xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06023732</url>
    </required_header>
    <id_info>
      <org_study_id>ERDEP</org_study_id>
      <nct_id>NCT06023732</nct_id>
    </id_info>
    <brief_title>Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression</brief_title>
    <official_title>Behavioral Activation and Emotion-focused Interventions in the Treatment of Depression, A Single-case Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Stockholm</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Region Stockholm</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is a single-case intervention study, evaluating effects of the treatment Behavioral&#xD;
        activation and emotion-focused interventions for depression.&#xD;
  &#xD;
        Research question and hypothesis&#xD;
  &#xD;
          1. What is the effect of behavioural activation and emotion-focused interventions on&#xD;
             patients' ratings of depressive symptoms, behavioural activation and emotion regulation&#xD;
             difficulties?&#xD;
  &#xD;
          2. What is the effect of behavioural activation and emotion-focused interventions on&#xD;
             patients' overall psychiatric state, with regards to ratings of anxiety, quality of&#xD;
             life, level of functioning?&#xD;
  &#xD;
          3. How does patient ratings of behavioural activation and emotion regulation difficulties&#xD;
             and skills change during the course of treatment, in relation to treatment/session&#xD;
             content?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Procedure The study will be carried out by the authors or experienced clinicians (master&#xD;
        level students at the Psychotherapy program at the Karolinska Institute), recruiting and&#xD;
        treating patients with recurring depression at a primary care unit in the Stockholm region. 7&#xD;
        patients will be treated during 15 weeks. The treatment will be carried out in a blended&#xD;
        format with an internet-based treatment supported with therapist face-to-face sessions. The&#xD;
        initial behavioural activation phase lasts up to 6 weeks followed by additional emotion&#xD;
        focused interventions. The treatment is initiated by a therapist session, thereafter&#xD;
        therapist sessions are planned approximately every 3rd week.&#xD;
  &#xD;
        To be included in the study participants must meet diagnostic criteria for depression as&#xD;
        their primary problem according to DSM-5 (Diagnostic and Statistical Manual), have basic&#xD;
        reading and writing skills in Swedish, and not express acute suicidal ideation. Patients with&#xD;
        concurrent co-morbid psychiatric problems are eligible for inclusion unless another&#xD;
        psychiatric diagnosis is assessed as primary to depression. Patients will be recruited from&#xD;
        the regular flow of patients who seek treatment for psychological problems in the selected&#xD;
        clinic. If interested they will be contacted by the study therapists and screened and&#xD;
        assessed for eligibility after signing an informed consent.&#xD;
  &#xD;
        Participants meeting inclusion criteria and not exclusion criteria will be offered&#xD;
        participation in the study, and randomized to one of the 7 baseline lengths.&#xD;
  &#xD;
        Methodology/approach/data analysis The research question will be investigated using a&#xD;
        multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and&#xD;
        14 days, assessing the pattern of depression, behavioral activation and difficulties in&#xD;
        emotion regulation before the intervention. Phase B comprise behavioral activation and&#xD;
        emotion focused interventions as the independent variable and makes it possible to evaluate&#xD;
        the effect of treatment on the dependent variable depressive symptoms. The B-phase will last&#xD;
        15 weeks and include the full internet-based treatment supported with 5-10 face-to-face&#xD;
        therapist sessions .&#xD;
  &#xD;
        Single-case experimental design (SCED) is particularly useful when evaluating a novel&#xD;
        treatment in a clinical context as it produces reliable results even with a small sample&#xD;
        size. Also, it is particularly helpful for studying the details of how the intervention works&#xD;
        for each individual patient, through detailed and repeated measures of several dependent&#xD;
        variables and processes. It is recommended that the effect of the intervention is assessed in&#xD;
        at least 3 individuals (1), however, we will recruit at least 7 participants to allow for&#xD;
        higher statistical power and as a safety measure for drop out and missing data.&#xD;
  &#xD;
        Primary treatment effects in terms of depression, behavioural activation and emotion&#xD;
        regulation will be assessed daily from day of inclusion to end of follow-up, with brief&#xD;
        versions of self-rated measures with good reliability and validity. Brief versions of the&#xD;
        following scales will be used for the daily assessment; depressive symptoms PHQ-2 (2),&#xD;
        difficulties in emotion regulation, and daily behavioural activation BADS (3). Longitudinal&#xD;
        data will be analyzed with non-parametric statistical tests (1). Visual inspection will be&#xD;
        used to analyse variability, trends and patterns of change in the daily assessments over the&#xD;
        phases of treatment.&#xD;
  &#xD;
        Kendal's Tau is a non-overlap statistical test that has been developed for analysing SCED&#xD;
        time series data with adequate statistical power. It will be used to analyse statistical&#xD;
        differences in the dependent variables between phases. Kendal's Tau will be complemented with&#xD;
        Tau-U tests if there are statistical trends in the data-series. Statistical power is very&#xD;
        difficult to calculate for this test but given the expected medium effect sizes of the&#xD;
        interventions and the replication across five participants, the statistical power is assessed&#xD;
        as adequate. Pre, post and follow-up data will be assessed at start of phase A, start of&#xD;
        phase B, after phase B and at follow up 3 months post treatment. The measures used will be&#xD;
        PHQ-9 (4) for depression, GAD-7 (5) for anxiety symptoms, WSAS (6) for disability and ISI (7)&#xD;
        for symptoms of insomnia. To measure if the treatment affects emotion regulation,&#xD;
        self-ratings of DERS 16 (8) will be used. Post treatment the CSQ-8 (9) will be used to assess&#xD;
        treatment satisfaction and NEQ (10) to asses negative effects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 20, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The research question will be investigated using a multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and 14 days, assessing the pattern of depression, behavioral activation and difficulties in emotion regulation before the intervention. Phase B comprise behavioral activation and emotion focused interventions as the independent variable and makes it possible to evaluate the effect of treatment on the dependent variable depressive symptoms.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Health Questionnaire-2 (PHQ-2)</measure>
      <time_frame>Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)</time_frame>
      <description>The PHQ-2 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 6. Higher scores indicating more symptoms. The items correspond to the core criteria for depression in the DSM-IV.&#xD;
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.&#xD;
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps are scored from 0 to 3 and summed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>2 item Behavioral Activation for Depression Scale (BADS)</measure>
      <time_frame>Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)</time_frame>
      <description>The scale is designed to be administered weekly to measure changes over the course of Behavioral Activation for depression. The 2 most central items concerning rumination and behavioral activation are chosen and rated 0-6 from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-12.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Emotion Regulation</measure>
      <time_frame>Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)</time_frame>
      <description>2 items regarding self rated emotion regulation. Items: Today I have been able to understand my emotions and needs, Today I have been able to accept my emotions and needs are rated from 1-5 where 1= Almost never and 5= Almost always. Total score ranges from 2-10 where higher scores indicate more sufficient emotion regulation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)</measure>
      <time_frame>Change from pre intervention to post intervention (15 weeks post intervention start)</time_frame>
      <description>Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)</measure>
      <time_frame>Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)</time_frame>
      <description>Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)</measure>
      <time_frame>Change from pre intervention to follow up 6 months post intervention start</time_frame>
      <description>Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)</measure>
      <time_frame>Change from pre intervention to follow up 12 months post intervention start</time_frame>
      <description>Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Change from pre intervention to post intervention (15 weeks post intervention start)</time_frame>
      <description>The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.&#xD;
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.&#xD;
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)</time_frame>
      <description>The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.&#xD;
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.&#xD;
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Change from pre intervention to post intervention follow up 6 months post intervention start</time_frame>
      <description>The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.&#xD;
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.&#xD;
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Change from pre intervention to follow up 12 months post intervention start</time_frame>
      <description>The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.&#xD;
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.&#xD;
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavioral Activation for Depression Scale (BADS) short version 9 items</measure>
      <time_frame>Change from pre intervention to post intervention (15 weeks post intervention start)</time_frame>
      <description>The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavioral Activation for Depression Scale (BADS) short version 9 items</measure>
      <time_frame>Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)</time_frame>
      <description>The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavioral Activation for Depression Scale (BADS) short version 9 items</measure>
      <time_frame>Change from pre intervention to follow up 6 months post intervention start</time_frame>
      <description>The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavioral Activation for Depression Scale (BADS) short version 9 items</measure>
      <time_frame>Change from pre intervention to follow up 12 months post intervention start</time_frame>
      <description>The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder 7-item scale (GAD-7)</measure>
      <time_frame>Change from pre intervention to post intervention (15 weeks post intervention start)</time_frame>
      <description>The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder 7-item scale (GAD-7)</measure>
      <time_frame>Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)</time_frame>
      <description>The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder 7-item scale (GAD-7)</measure>
      <time_frame>Change from pre intervention to follow up 6 months post intervention start</time_frame>
      <description>The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder 7-item scale (GAD-7)</measure>
      <time_frame>Change from pre intervention to follow up 12 months post intervention start</time_frame>
      <description>The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Change from pre intervention to post intervention (15 weeks post intervention start)</time_frame>
      <description>A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for &quot;not at all&quot; and 4 stands for &quot;very much&quot;. The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)</time_frame>
      <description>A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for &quot;not at all&quot; and 4 stands for &quot;very much&quot;. The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Change from pre intervention to follow up 6 months post intervention start</time_frame>
      <description>A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for &quot;not at all&quot; and 4 stands for &quot;very much&quot;. The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Change from pre intervention to follow up 12 months post intervention start</time_frame>
      <description>A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for &quot;not at all&quot; and 4 stands for &quot;very much&quot;. The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Change from pre intervention to post intervention (15 weeks post intervention start)</time_frame>
      <description>The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Change from pre intervention to post post Behavioral activation phase (5 weeks post intervention start)</time_frame>
      <description>The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Change from pre intervention to follow up 6 months post intervention start</time_frame>
      <description>The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Change from pre intervention to follow up 12 months post intervention start</time_frame>
      <description>The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Satisfaction Questionnaire (CSQ-8)</measure>
      <time_frame>Immediately post intervention</time_frame>
      <description>Self rated questionnaire to rate satisfaction with treatment. 8 items rated from 1-4 and summarized. Lower scores indicating less satisfaction. Scale ranging from 0-32</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative Effects Questionnaire (NEQ)</measure>
      <time_frame>Immediately post intervention</time_frame>
      <description>self-rating form to measure negative effects of psychological treatment The NEQ consists of 20 statements that are answered on a 0-4 Likert scale. Furthermore, there is an open question to try to capture such negative effects that are not included in the self-report form, but which may be of theoretical or clinical relevance. In addition, the respondent is asked to answer whether the negative effects experienced were due to the treatment they underwent or other circumstances. The scale ranges from 0-80, higher scores indicate more negative effects. However the scale is more descriptive than designed to calculate negative effects</description>
    </secondary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">7</enrollment>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Baseline 7 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baseline 8 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baseline 9 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baseline 10 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baseline 11 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baseline 12 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baseline 13 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baseline 14 days</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioral activation and emotion-focused interventions</intervention_name>
      <description>Behavioral activation with emotion-focused interventions comprises two consecutive phases. In the first phase, treatment focus is behavioral activation in line with Brief behavioral activation treatment for depression - revised (BATD-R; 11) During the second phase, treatment focus shifts to address participants' emotions. Difficulties in understanding, tolerating, and labeling emotions is addressed by observing and describing emotions (12). Under the guidance of the therapist, participants are instructed to explore emotions normally avoided or ruminated on. This is conceptualized as a form of exposure to aversive emotions, thoughts and memories, to initiate emotional processing (13).</description>
      <arm_group_label>Baseline 10 days</arm_group_label>
      <arm_group_label>Baseline 11 days</arm_group_label>
      <arm_group_label>Baseline 12 days</arm_group_label>
      <arm_group_label>Baseline 13 days</arm_group_label>
      <arm_group_label>Baseline 14 days</arm_group_label>
      <arm_group_label>Baseline 7 days</arm_group_label>
      <arm_group_label>Baseline 8 days</arm_group_label>
      <arm_group_label>Baseline 9 days</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  meet diagnostic criteria for depression as their primary problem according to DSM-5&#xD;
  &#xD;
            -  have basic reading and writing skills in Swedish&#xD;
  &#xD;
            -  not express acute suicidal ideation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  concurrent comorbid psychiatric problems assessed as primary to depression.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sigrid Salomonsson, PhD</last_name>
      <phone>0708442283</phone>
      <email>sigrid.salomonsson@regionstockholm.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hanna Sahlin, PhD</last_name>
      <email>hanna.sahlin@ki.se</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Liljeholmens primary care centre</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
      <contact>
        <last_name>Sigrid Salomonsson</last_name>
        <email>sigrid.salomonsson@ki.se</email>
      </contact>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <reference>
      <citation>Dugard P, File, P., Todman, J. Singel-case and Small-n experimental designs. New york: Routledge; 2001.</citation>
    </reference>
    <reference>
      <citation>Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.</citation>
      <PMID>14583691</PMID>
    </reference>
    <reference>
      <citation>Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. The Behavioral Activation for Depression Scale (BADS): Psychometric Properties and Factor Structure. Journal of Psychopathology and Behavioral Assessment. 2006;29(3):191.</citation>
    </reference>
    <reference>
      <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.</citation>
      <PMID>11556941</PMID>
    </reference>
    <reference>
      <citation>Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.</citation>
      <PMID>16717171</PMID>
    </reference>
    <reference>
      <citation>Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.</citation>
      <PMID>11983645</PMID>
    </reference>
    <reference>
      <citation>Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.</citation>
      <PMID>11438246</PMID>
    </reference>
    <reference>
      <citation>Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.</citation>
      <PMID>27239096</PMID>
    </reference>
    <reference>
      <citation>Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.</citation>
      <PMID>10259963</PMID>
    </reference>
    <reference>
      <citation>Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.</citation>
      <PMID>30871650</PMID>
    </reference>
    <reference>
      <citation>Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.</citation>
      <PMID>21324944</PMID>
    </reference>
    <reference>
      <citation>Linehan MM. Cognitive Behavioral Treatment of Borderline Personality Disorder. New York: Guilford Press; 1993.</citation>
    </reference>
    <reference>
      <citation>Greenberg, Leslie S. and Goldman, Rhonda N. Clinical Handbook of Emotion-Focused Therapy. American Psychological Association. (2018).</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06023732
  org study id: ERDEP
  nct id: NCT06023732
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is a single-case intervention study, evaluating effects of the treatment Behavioral
        activation and emotion-focused interventions for depression.
  
        Research question and hypothesis
  
          1. What is the effect of behavioural activation and emotion-focused interventions on
             patients' ratings of depressive symptoms, behavioural activation and emotion regulation
             difficulties?
  
          2. What is the effect of behavioural activation and emotion-focused interventions on
             patients' overall psychiatric state, with regards to ratings of anxiety, quality of
             life, level of functioning?
  
          3. How does patient ratings of behavioural activation and emotion regulation difficulties
             and skills change during the course of treatment, in relation to treatment/session
             content?
  Procedure The study will be carried out by the authors or experienced clinicians (master
        level students at the Psychotherapy program at the Karolinska Institute), recruiting and
        treating patients with recurring depression at a primary care unit in the Stockholm region. 7
        patients will be treated during 15 weeks. The treatment will be carried out in a blended
        format with an internet-based treatment supported with therapist face-to-face sessions. The
        initial behavioural activation phase lasts up to 6 weeks followed by additional emotion
        focused interventions. The treatment is initiated by a therapist session, thereafter
        therapist sessions are planned approximately every 3rd week.
  
        To be included in the study participants must meet diagnostic criteria for depression as
        their primary problem according to DSM-5 (Diagnostic and Statistical Manual), have basic
        reading and writing skills in Swedish, and not express acute suicidal ideation. Patients with
        concurrent co-morbid psychiatric problems are eligible for inclusion unless another
        psychiatric diagnosis is assessed as primary to depression. Patients will be recruited from
        the regular flow of patients who seek treatment for psychological problems in the selected
        clinic. If interested they will be contacted by the study therapists and screened and
        assessed for eligibility after signing an informed consent.
  
        Participants meeting inclusion criteria and not exclusion criteria will be offered
        participation in the study, and randomized to one of the 7 baseline lengths.
  
        Methodology/approach/data analysis The research question will be investigated using a
        multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and
        14 days, assessing the pattern of depression, behavioral activation and difficulties in
        emotion regulation before the intervention. Phase B comprise behavioral activation and
        emotion focused interventions as the independent variable and makes it possible to evaluate
        the effect of treatment on the dependent variable depressive symptoms. The B-phase will last
        15 weeks and include the full internet-based treatment supported with 5-10 face-to-face
        therapist sessions .
  
        Single-case experimental design (SCED) is particularly useful when evaluating a novel
        treatment in a clinical context as it produces reliable results even with a small sample
        size. Also, it is particularly helpful for studying the details of how the intervention works
        for each individual patient, through detailed and repeated measures of several dependent
        variables and processes. It is recommended that the effect of the intervention is assessed in
        at least 3 individuals (1), however, we will recruit at least 7 participants to allow for
        higher statistical power and as a safety measure for drop out and missing data.
  
        Primary treatment effects in terms of depression, behavioural activation and emotion
        regulation will be assessed daily from day of inclusion to end of follow-up, with brief
        versions of self-rated measures with good reliability and validity. Brief versions of the
        following scales will be used for the daily assessment; depressive symptoms PHQ-2 (2),
        difficulties in emotion regulation, and daily behavioural activation BADS (3). Longitudinal
        data will be analyzed with non-parametric statistical tests (1). Visual inspection will be
        used to analyse variability, trends and patterns of change in the daily assessments over the
        phases of treatment.
  
        Kendal's Tau is a non-overlap statistical test that has been developed for analysing SCED
        time series data with adequate statistical power. It will be used to analyse statistical
        differences in the dependent variables between phases. Kendal's Tau will be complemented with
        Tau-U tests if there are statistical trends in the data-series. Statistical power is very
        difficult to calculate for this test but given the expected medium effect sizes of the
        interventions and the replication across five participants, the statistical power is assessed
        as adequate. Pre, post and follow-up data will be assessed at start of phase A, start of
        phase B, after phase B and at follow up 3 months post treatment. The measures used will be
        PHQ-9 (4) for depression, GAD-7 (5) for anxiety symptoms, WSAS (6) for disability and ISI (7)
        for symptoms of insomnia. To measure if the treatment affects emotion regulation,
        self-ratings of DERS 16 (8) will be used. Post treatment the CSQ-8 (9) will be used to assess
        treatment satisfaction and NEQ (10) to asses negative effects.
  allocation: Randomized
  intervention model: Single Group Assignment
  intervention model description: The research question will be investigated using a multiple baseline single-case A-B design. A will be the baseline phase, varying between 7 and 14 days, assessing the pattern of depression, behavioral activation and difficulties in emotion regulation before the intervention. Phase B comprise behavioral activation and emotion focused interventions as the independent variable and makes it possible to evaluate the effect of treatment on the dependent variable depressive symptoms.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Patient Health Questionnaire-2 (PHQ-2)
  time frame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
  description: The PHQ-2 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 6. Higher scores indicating more symptoms. The items correspond to the core criteria for depression in the DSM-IV.
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps are scored from 0 to 3 and summed.
  measure: 2 item Behavioral Activation for Depression Scale (BADS)
  time frame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
  description: The scale is designed to be administered weekly to measure changes over the course of Behavioral Activation for depression. The 2 most central items concerning rumination and behavioral activation are chosen and rated 0-6 from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-12.
  measure: Emotion Regulation
  time frame: Change from baseline (pre intervention start) to post intervention (15 weeks post intervention start)
  description: 2 items regarding self rated emotion regulation. Items: Today I have been able to understand my emotions and needs, Today I have been able to accept my emotions and needs are rated from 1-5 where 1= Almost never and 5= Almost always. Total score ranges from 2-10 where higher scores indicate more sufficient emotion regulation.
  measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
  time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
  description: Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
  measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
  time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
  description: Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
  measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
  time frame: Change from pre intervention to follow up 6 months post intervention start
  description: Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
  measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
  time frame: Change from pre intervention to follow up 12 months post intervention start
  description: Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
  description: The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
  description: The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: Change from pre intervention to post intervention follow up 6 months post intervention start
  description: The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: Change from pre intervention to follow up 12 months post intervention start
  description: The PHQ-9 is a brief self-rating scale for screening major depression according to DSMIV and measuring current symptom level of depression. Min 0 max 27. Higher scores indicating more symptoms. The first nine items in the PHQ-9 correspond to the nine criteria for depression in the DSM-IV. The tenth item is a simple function scale.
  The scale can be used as screening for the criteria for a depressive syndrome may be present according to DSM-IV.
  You can also use the sum score as a measure of the current level of symptoms to assess the depth of depression and follow a course over time. The scale steps for the first 9 items are scored from 0 to 3 and summed.
  measure: Behavioral Activation for Depression Scale (BADS) short version 9 items
  time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
  description: The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.
  measure: Behavioral Activation for Depression Scale (BADS) short version 9 items
  time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
  description: The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.
  measure: Behavioral Activation for Depression Scale (BADS) short version 9 items
  time frame: Change from pre intervention to follow up 6 months post intervention start
  description: The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.
  measure: Behavioral Activation for Depression Scale (BADS) short version 9 items
  time frame: Change from pre intervention to follow up 12 months post intervention start
  description: The questionnaire is designed to measure changes in avoidance and activation over the course of Behavioral Activation for depression. Items are rated from Not at all to Completely, where higher scores indicate more sufficient behavioral activation (less depressed behavior). Total score ranges from 0-54.
  measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
  time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
  description: The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.
  measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
  time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
  description: The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.
  measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
  time frame: Change from pre intervention to follow up 6 months post intervention start
  description: The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.
  measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
  time frame: Change from pre intervention to follow up 12 months post intervention start
  description: The GAD-7 is an instrument developed to help people who have anxiety symptoms that can be described as GAD. The test is only indicative and can never replace a doctor's visit and accurate diagnostics. The questions can be a help for the customer to identify any problems together with their doctor. If the client is already undergoing treatment for GAD, it may also be valuable to do a self-assessment from time to time to evaluate the effect of the treatment. A good opportunity can be in connection with and before a return visit to a doctor or psychologist or alternatively in connection with the renewal of a prescription. The customer can print out and take the test result to their doctor. The seven questions are scored from 0 (Not at all) to 3 (Daily) and summed. The total score is thus within the range 0-21.
  measure: Insomnia Severity Index (ISI)
  time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
  description: A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.
  measure: Insomnia Severity Index (ISI)
  time frame: Change from pre intervention to post Behavioral activation phase (5 weeks post intervention start)
  description: A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.
  measure: Insomnia Severity Index (ISI)
  time frame: Change from pre intervention to follow up 6 months post intervention start
  description: A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.
  measure: Insomnia Severity Index (ISI)
  time frame: Change from pre intervention to follow up 12 months post intervention start
  description: A self-report questionnaire intended to measure insomnia. The purpose of the form is to quickly obtain a measure of the severity of sleep problems. The scale consists of 7 questions that evaluate falling asleep, sleep during the night, early awakening, the feeling of being rested, how sleep problems affect daily life and how the sleep pattern worries the individual. For each question, the participants must take a position on how they have experienced their sleeping habits in the past two weeks and then indicate the answers on a five-point Likert scale from 0 to 4, where 0 stands for "not at all" and 4 stands for "very much". The points are then added up. The total can be from 0 to 28 points. High scores indicate more severe sleep problems.
  measure: The Work and Social Adjustment Scale (WSAS)
  time frame: Change from pre intervention to post intervention (15 weeks post intervention start)
  description: The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
  measure: The Work and Social Adjustment Scale (WSAS)
  time frame: Change from pre intervention to post post Behavioral activation phase (5 weeks post intervention start)
  description: The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
  measure: The Work and Social Adjustment Scale (WSAS)
  time frame: Change from pre intervention to follow up 6 months post intervention start
  description: The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
  measure: The Work and Social Adjustment Scale (WSAS)
  time frame: Change from pre intervention to follow up 12 months post intervention start
  description: The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
  measure: Client Satisfaction Questionnaire (CSQ-8)
  time frame: Immediately post intervention
  description: Self rated questionnaire to rate satisfaction with treatment. 8 items rated from 1-4 and summarized. Lower scores indicating less satisfaction. Scale ranging from 0-32
  measure: Negative Effects Questionnaire (NEQ)
  time frame: Immediately post intervention
  description: self-rating form to measure negative effects of psychological treatment The NEQ consists of 20 statements that are answered on a 0-4 Likert scale. Furthermore, there is an open question to try to capture such negative effects that are not included in the self-report form, but which may be of theoretical or clinical relevance. In addition, the respondent is asked to answer whether the negative effects experienced were due to the treatment they underwent or other circumstances. The scale ranges from 0-80, higher scores indicate more negative effects. However the scale is more descriptive than designed to calculate negative effects
  arm group label: Baseline 7 days
  arm group type: Experimental
  description: Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
  arm group label: Baseline 8 days
  arm group type: Experimental
  description: Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
  arm group label: Baseline 9 days
  arm group type: Experimental
  description: Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
  arm group label: Baseline 10 days
  arm group type: Experimental
  description: Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
  arm group label: Baseline 11 days
  arm group type: Experimental
  description: Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
  arm group label: Baseline 12 days
  arm group type: Experimental
  description: Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
  arm group label: Baseline 13 days
  arm group type: Experimental
  description: Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
  arm group label: Baseline 14 days
  arm group type: Experimental
  description: Behavioral activation and emotion-focused interventions Baseline randomized length 7-14 days
  intervention type: Behavioral
  intervention name: Behavioral activation and emotion-focused interventions
  description: Behavioral activation with emotion-focused interventions comprises two consecutive phases. In the first phase, treatment focus is behavioral activation in line with Brief behavioral activation treatment for depression - revised (BATD-R; 11) During the second phase, treatment focus shifts to address participants' emotions. Difficulties in understanding, tolerating, and labeling emotions is addressed by observing and describing emotions (12). Under the guidance of the therapist, participants are instructed to explore emotions normally avoided or ruminated on. This is conceptualized as a form of exposure to aversive emotions, thoughts and memories, to initiate emotional processing (13).
  arm group label: Baseline 10 days
  arm group label: Baseline 11 days
  arm group label: Baseline 12 days
  arm group label: Baseline 13 days
  arm group label: Baseline 14 days
  arm group label: Baseline 7 days
  arm group label: Baseline 8 days
  arm group label: Baseline 9 days
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sigrid Salomonsson, PhD
  phone: 0708442283
  email: sigrid.salomonsson@regionstockholm.se
  last name: Hanna Sahlin, PhD
  email: hanna.sahlin@ki.se
  facility: 
  contact: 
  country: Sweden
  citation: Dugard P, File, P., Todman, J. Singel-case and Small-n experimental designs. New york: Routledge; 2001.
  citation: Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003 Nov;41(11):1284-92. doi: 10.1097/01.MLR.0000093487.78664.3C.
  PMID: 14583691
  citation: Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. The Behavioral Activation for Depression Scale (BADS): Psychometric Properties and Factor Structure. Journal of Psychopathology and Behavioral Assessment. 2006;29(3):191.
  citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
  PMID: 11556941
  citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
  PMID: 16717171
  citation: Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
  PMID: 11983645
  citation: Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
  PMID: 11438246
  citation: Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.
  PMID: 27239096
  citation: Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
  PMID: 10259963
  citation: Rozental A, Kottorp A, Forsstrom D, Mansson K, Boettcher J, Andersson G, Furmark T, Carlbring P. The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments. Behav Cogn Psychother. 2019 Sep;47(5):559-572. doi: 10.1017/S1352465819000018. Epub 2019 Mar 15.
  PMID: 30871650
  citation: Lejuez CW, Hopko DR, Acierno R, Daughters SB, Pagoto SL. Ten year revision of the brief behavioral activation treatment for depression: revised treatment manual. Behav Modif. 2011 Mar;35(2):111-61. doi: 10.1177/0145445510390929.
  PMID: 21324944
  citation: Linehan MM. Cognitive Behavioral Treatment of Borderline Personality Disorder. New York: Guilford Press; 1993.
  citation: Greenberg, Leslie S. and Goldman, Rhonda N. Clinical Handbook of Emotion-Focused Therapy. American Psychological Association. (2018).
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: No