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/NCT06022913</url>
    </required_header>
    <id_info>
      <org_study_id>BD0323</org_study_id>
      <nct_id>NCT06022913</nct_id>
    </id_info>
    <brief_title>Behavioural Activation for Bipolar Depression</brief_title>
    <official_title>Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Reykjavik University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Landspitali University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Reykjavik University</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>
        Bipolar disorder (BD) affects between 1-3% of the world's population. People with BD&#xD;
        experience episodes of mania or hypomania and in most cases, they experience periods of&#xD;
        depression which can cause difficulties in daily life. Psychological therapies for people&#xD;
        experiencing depression without mania or hypomania are widely available, but there is little&#xD;
        research into how effective these therapies are for people with BD. Behavioral activation&#xD;
        therapy (BA) is based on behavioral theory and has been proven to be an effective treatment&#xD;
        for unipolar depression. It helps people re-establish healthier activity patterns and sleep&#xD;
        regulation, especially in BD for mood stabilization. BA is theoretically and clinically well&#xD;
        matched to the treatment of bipolar depression, but there is still very little research into&#xD;
        offering BA to people with BD.&#xD;
  &#xD;
        The first aim of the current research is to implement BA for people with depression in&#xD;
        Bipolar Disorder and study if it is feasible for this patient group. The second aim is to do&#xD;
        a pilot study on the effectiveness of the treatment for this patient group. The research will&#xD;
        be implemented with people seeking treatment at the specialized service for bipolar disorder&#xD;
        at Landspítali University Hospital in Iceland. The participants will receive treatment as&#xD;
        usual and the BA will be adjunctive.&#xD;
  &#xD;
        At least ten people, that are currently experiencing Bipolar Depression and are willing to&#xD;
        take part, will receive up to 20 individual therapy sessions of BA that have been adapted for&#xD;
        Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews.&#xD;
  &#xD;
        The study will be a replication study to validate the previous study's findings by Kim, W. et&#xD;
        al., 2022 in another setting.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Parallel Assignment</intervention_model>
      <intervention_model_description>This is a case series using a multiple baseline design whereby participants are randomly allocated to one of 6 durations of wait at baseline before commencing treatment.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>It is not possible to blind the assessor to phase or baseline duration of participants in the case-series, as the length of time between assessments will reveal this. Nevertheless, the assessor and clients will be asked not to disclose which therapist is treating them. Use of self-report measures as the primary outcome measure is intended to minimize potential biases on the side of the researcher.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Minimally clinically significant improvement in depression symptoms for a majority of participants (&gt;60%)</measure>
      <time_frame>through study completion, an average of 7 months</time_frame>
      <description>Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Therapy uptake rate</measure>
      <time_frame>through study completion, an average of 7 months</time_frame>
      <description>Number of participants randomised who attend at least 1 treatment session</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Therapy completion rate</measure>
      <time_frame>through study completion, an average of 7 months</time_frame>
      <description>Proportion of participants that attend at least 8 treatment sessions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in activity levels as measured by consumer connected health devices</measure>
      <time_frame>through study completion, an average of 7 months</time_frame>
      <description>Measures of activity levels as by Withings health devices</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Sleep Duration measured by health device</measure>
      <time_frame>through study completion, an average of 7 months</time_frame>
      <description>Measures of sleep duration by Withings health devices</description>
    </primary_outcome>
    <primary_outcome>
      <measure>No significant adverse reaction for participants</measure>
      <time_frame>through study completion, an average of 7 months</time_frame>
      <description>Participant reports of adverse events elicited by researchers and therapists</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Altman Self-Rating Mania Scale (ASRM)</measure>
      <time_frame>1 week</time_frame>
      <description>5 item self-report measure of hypomania symptoms over the past week</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>24 hours</time_frame>
      <description>5 item self-report scale of functional impairment attributable to an identified problem</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hamilton Depression Scale (HAM-D)</measure>
      <time_frame>1 week</time_frame>
      <description>17 item observer-rated scale measuring symptoms of depression over the past week</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Quality of Life in Bipolar Disorder (Brief QoLBD)</measure>
      <time_frame>1 week</time_frame>
      <description>12 item self-report measure of disorder-specific quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Anxiety Disorder Assessment - 7 (GAD7)</measure>
      <time_frame>2 weeks</time_frame>
      <description>7 item self-report measure of anxiety symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Behavioral Activation for Depression Scale (BADS)</measure>
      <time_frame>1 week</time_frame>
      <description>25 item self-report measure of changes in activation and avoidance over the past week</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Snaith-Hamilton Pleasure Scale (SHAPS)</measure>
      <time_frame>1 week</time_frame>
      <description>14 item self-report measure of level of anhedonia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mini International Neuropsychiatric Interview (MINI) 7.0.2</measure>
      <time_frame>Six months</time_frame>
      <description>Standardized interview to establish whether the participant meets research diagnostic criteria for lifetime Bipolar I or II Disorder, current depressive episode, and to establish whether they are experiencing current substance dependence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Young mania rating scale</measure>
      <time_frame>48 hours</time_frame>
      <description>11 item observer-rated scale measuring the severity of manic states</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six daily questions</measure>
      <time_frame>24 hours</time_frame>
      <description>Six daily questions in mobile about goal achievement, mood, sleep etc</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Quality of Behavioral Activation Scale (Q-BAS)</measure>
      <time_frame>1 week</time_frame>
      <description>To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Bipolar Depression</condition>
    <arm_group>
      <arm_group_label>2 week wait</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participant waits for 2 weeks after their baseline assessment before commencing therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3 week wait</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participant waits for 3 weeks after their baseline assessment before commencing therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>4 week wait</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participant waits for 4 weeks after their baseline assessment before commencing therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>5 week wait</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participant waits for 5 weeks after their baseline assessment before commencing therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Behavioural Activation (BA)</intervention_name>
      <description>BA is based on the assumption that depression may be precipitated and is maintained by a reduction in &quot;healthy&quot;, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term.&#xD;
  The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.</description>
      <arm_group_label>2 week wait</arm_group_label>
      <arm_group_label>3 week wait</arm_group_label>
      <arm_group_label>4 week wait</arm_group_label>
      <arm_group_label>5 week wait</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  scoring in the clinical range on a self-report measure of depression severity (the&#xD;
               PHQ-9) meeting diagnostic criteria for depression based on a diagnosis on Mini&#xD;
               International Neuropsychiatric Interview (MINI) 7.0.2 meeting diagnostic criteria for&#xD;
               Bipolar I or II Disorder (MINI) participants will require a working knowledge of&#xD;
               written and spoken Icelandic, sufficient to make use of therapy and complete research&#xD;
               assessments without the need for a translator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  current/past learning disability, organic brain change, substance dependence (drugs&#xD;
               and alcohol) that would compromise the ability to use therapy&#xD;
  &#xD;
            -  current marked risk to self (i.e., self-harm or suicide) that we deem could not be&#xD;
               appropriately managed in the Bipolar outpatient clinic at Landspitali.&#xD;
  &#xD;
            -  currently lacking the capacity to give informed consent&#xD;
  &#xD;
            -  currently receiving other psychosocial therapy for depression or bipolar disorder&#xD;
  &#xD;
            -  presence of another area of difficulty that the therapist and client believe should be&#xD;
               the primary focus of intervention (for example, Post-Traumatic Stress Disorder,&#xD;
               psychosis)&#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_official>
      <last_name>Brynja B Magnúsdóttir, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Reykjavik University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Anna S Islind, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Reykjavik University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Steinunn G Sigurðardóttir, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Reykjavik University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Halla Ó Ólafsdóttir, Cand. psych</last_name>
      <phone>8688371</phone>
      <email>hallaosh@landspitali.is</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Brynja Bj Magnúsdóttir, PhD</last_name>
      <phone>8489685</phone>
      <email>brynjabm@ru.is</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Landspitali university hospital</name>
        <address>
          <city>Reykjavík</city>
          <zip>101</zip>
          <country>Iceland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Halla Ó Ólafsdóttir, Cand. psych</last_name>
        <phone>003548688371</phone>
        <email>hallaosh@landspitali.is</email>
      </contact>
      <contact_backup>
        <last_name>Brynja B Magnúsdóttir, PhD, cand psych</last_name>
        <phone>003548489685</phone>
        <email>brynjabm@ru.is</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Iceland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Reykjavik University</investigator_affiliation>
      <investigator_full_name>Brynja Bjork Magnusdottir</investigator_full_name>
      <investigator_title>Assistant professor, Psychologist</investigator_title>
    </responsible_party>
    <keyword>Bipolar depression</keyword>
    <keyword>Bipolar Disorder</keyword>
    <keyword>Behavioural Activation</keyword>
    <keyword>Depression</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Bipolar Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>Access will be possible from the date of publication.</ipd_time_frame>
      <ipd_access_criteria>The dataset will be anonymous and registered with a metadata-only record, allowing the research team to control access to the dataset, and restricting it to appropriately qualified third parties.</ipd_access_criteria>
    </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/NCT06022913
  org study id: BD0323
  nct id: NCT06022913
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Bipolar disorder (BD) affects between 1-3% of the world's population. People with BD
        experience episodes of mania or hypomania and in most cases, they experience periods of
        depression which can cause difficulties in daily life. Psychological therapies for people
        experiencing depression without mania or hypomania are widely available, but there is little
        research into how effective these therapies are for people with BD. Behavioral activation
        therapy (BA) is based on behavioral theory and has been proven to be an effective treatment
        for unipolar depression. It helps people re-establish healthier activity patterns and sleep
        regulation, especially in BD for mood stabilization. BA is theoretically and clinically well
        matched to the treatment of bipolar depression, but there is still very little research into
        offering BA to people with BD.
  
        The first aim of the current research is to implement BA for people with depression in
        Bipolar Disorder and study if it is feasible for this patient group. The second aim is to do
        a pilot study on the effectiveness of the treatment for this patient group. The research will
        be implemented with people seeking treatment at the specialized service for bipolar disorder
        at Landspítali University Hospital in Iceland. The participants will receive treatment as
        usual and the BA will be adjunctive.
  
        At least ten people, that are currently experiencing Bipolar Depression and are willing to
        take part, will receive up to 20 individual therapy sessions of BA that have been adapted for
        Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews.
  
        The study will be a replication study to validate the previous study's findings by Kim, W. et
        al., 2022 in another setting.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a case series using a multiple baseline design whereby participants are randomly allocated to one of 6 durations of wait at baseline before commencing treatment.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: It is not possible to blind the assessor to phase or baseline duration of participants in the case-series, as the length of time between assessments will reveal this. Nevertheless, the assessor and clients will be asked not to disclose which therapist is treating them. Use of self-report measures as the primary outcome measure is intended to minimize potential biases on the side of the researcher.
  measure: Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
  time frame: through study completion, an average of 7 months
  description: Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
  measure: Therapy uptake rate
  time frame: through study completion, an average of 7 months
  description: Number of participants randomised who attend at least 1 treatment session
  measure: Therapy completion rate
  time frame: through study completion, an average of 7 months
  description: Proportion of participants that attend at least 8 treatment sessions
  measure: Change in activity levels as measured by consumer connected health devices
  time frame: through study completion, an average of 7 months
  description: Measures of activity levels as by Withings health devices
  measure: Change in Sleep Duration measured by health device
  time frame: through study completion, an average of 7 months
  description: Measures of sleep duration by Withings health devices
  measure: No significant adverse reaction for participants
  time frame: through study completion, an average of 7 months
  description: Participant reports of adverse events elicited by researchers and therapists
  measure: Altman Self-Rating Mania Scale (ASRM)
  time frame: 1 week
  description: 5 item self-report measure of hypomania symptoms over the past week
  measure: Work and Social Adjustment Scale (WSAS)
  time frame: 24 hours
  description: 5 item self-report scale of functional impairment attributable to an identified problem
  measure: Hamilton Depression Scale (HAM-D)
  time frame: 1 week
  description: 17 item observer-rated scale measuring symptoms of depression over the past week
  measure: Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
  time frame: 1 week
  description: 12 item self-report measure of disorder-specific quality of life
  measure: General Anxiety Disorder Assessment - 7 (GAD7)
  time frame: 2 weeks
  description: 7 item self-report measure of anxiety symptoms
  measure: Behavioral Activation for Depression Scale (BADS)
  time frame: 1 week
  description: 25 item self-report measure of changes in activation and avoidance over the past week
  measure: Snaith-Hamilton Pleasure Scale (SHAPS)
  time frame: 1 week
  description: 14 item self-report measure of level of anhedonia
  measure: Mini International Neuropsychiatric Interview (MINI) 7.0.2
  time frame: Six months
  description: Standardized interview to establish whether the participant meets research diagnostic criteria for lifetime Bipolar I or II Disorder, current depressive episode, and to establish whether they are experiencing current substance dependence
  measure: Young mania rating scale
  time frame: 48 hours
  description: 11 item observer-rated scale measuring the severity of manic states
  measure: Six daily questions
  time frame: 24 hours
  description: Six daily questions in mobile about goal achievement, mood, sleep etc
  measure: The Quality of Behavioral Activation Scale (Q-BAS)
  time frame: 1 week
  description: To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions
  arm group label: 2 week wait
  arm group type: Other
  description: Participant waits for 2 weeks after their baseline assessment before commencing therapy.
  arm group label: 3 week wait
  arm group type: Other
  description: Participant waits for 3 weeks after their baseline assessment before commencing therapy.
  arm group label: 4 week wait
  arm group type: Other
  description: Participant waits for 4 weeks after their baseline assessment before commencing therapy.
  arm group label: 5 week wait
  arm group type: Other
  description: Participant waits for 5 weeks after their baseline assessment before commencing therapy.
  intervention type: Behavioral
  intervention name: Behavioural Activation (BA)
  description: BA is based on the assumption that depression may be precipitated and is maintained by a reduction in "healthy", adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term.
  The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.
  arm group label: 2 week wait
  arm group label: 3 week wait
  arm group label: 4 week wait
  arm group label: 5 week wait
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brynja B Magnúsdóttir, PhD
  role: Study Chair
  affiliation: Reykjavik University
  last name: Anna S Islind, PhD
  role: Principal Investigator
  affiliation: Reykjavik University
  last name: Steinunn G Sigurðardóttir, MSc
  role: Principal Investigator
  affiliation: Reykjavik University
  last name: Halla Ó Ólafsdóttir, Cand. psych
  phone: 8688371
  email: hallaosh@landspitali.is
  last name: Brynja Bj Magnúsdóttir, PhD
  phone: 8489685
  email: brynjabm@ru.is
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Iceland
  responsible party type: Principal Investigator
  investigator affiliation: Reykjavik University
  investigator full name: Brynja Bjork Magnusdottir
  investigator title: Assistant professor, Psychologist
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Bipolar Disorder
  sharing ipd: Yes
  ipd description: All data that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: Access will be possible from the date of publication.
  ipd access criteria: The dataset will be anonymous and registered with a metadata-only record, allowing the research team to control access to the dataset, and restricting it to appropriately qualified third parties.