<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/NCT04498949</url>
  </required_header>
  <id_info>
    <org_study_id>Unified Protocol</org_study_id>
    <nct_id>NCT04498949</nct_id>
  </id_info>
  <brief_title>Transdiagnostic Treatment for Emotional Disorders</brief_title>
  <acronym>UP</acronym>
  <official_title>Transdiagnostic Treatment for University Students at Risk of Emotional Disorders: a Web Based Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohamad hasan yousefi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bamyan University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Background and study aims Depression is more prevalent in younger populations. The age of&#xD;
      first onset of depression has become younger, yet many adolescents with depressive symptoms&#xD;
      remain untreated. Rates of anxiety and depression are increasing among children and young&#xD;
      people.postsecondary education also represents a peak onset period for the occurrence of&#xD;
      mental disorders. It is estimated that 12-46% of all university students are affected by&#xD;
      mental health disorders in any given year. Who can participate? Afghan students over 18 years&#xD;
      old fluent in Persian or Pashto, and access to an internet connection. What does the study&#xD;
      involve? Participants will be randomly allocated to receive training in skills and coping&#xD;
      strategies which are useful in stressful conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Condition Depressive symptoms, anxiety symptom, emotional problems Interventions Participants&#xD;
      in experimental group Receive 12 weeks training according to the guideline below Participants&#xD;
      in control Receive treatment as usual, also the experts will respond to their questions. The&#xD;
      unified protocol can track its basis from cognitive-behavioral therapy approaches. As in the&#xD;
      traditional CBT approaches, the unified protocol has several modules whose base is the&#xD;
      emotions . The modules focus on increasing awareness of interaction and the function of the&#xD;
      model of emotion components which include thoughts, physical sensations, and behaviors. The&#xD;
      final bit of the unified protocol is to change the components to a present moment awareness.&#xD;
      The unified protocol is used to treat different emotional disorders unlike the traditional&#xD;
      CBT approaches. This is done by targeting the underlying mechanisms that form part of all&#xD;
      emotional disorders. The 5 core skills above are delivered to patients through five core&#xD;
      modules. Before the key modules, there are 2 modules for introduction and learning about&#xD;
      emotions. After the 5 core modules there is a module for treatment progress appraisal and&#xD;
      making plans to prevent relapse.&#xD;
&#xD;
      The unified protocol modules are as follows:&#xD;
&#xD;
      Module 1: Setting the treatment goals and motivation augmentation Module 2: Using&#xD;
      psychoeducation to learn the function of emotions and their development Module 3: Mindful&#xD;
      (present-focused and non-judgmental) emotional awareness- Core module Module 4: Cognitive&#xD;
      flexibility- Core module Module 5: Identifying and countering emotional avoidance behaviors-&#xD;
      core module Module 6: Increasing awareness and confronting physical sensations/ interoceptive&#xD;
      sensitivity- core module Module 7: Both situational and interoceptive emotion-focused&#xD;
      exposures- Core module Module 8: Recognizing accomplishments and looking to the future&#xD;
      (relapse prevention) Primary outcome measure&#xD;
&#xD;
      At baseline and 12 weeks:&#xD;
&#xD;
        1. Anxiety measured using the Beck Anxiety Inventory (BAI)&#xD;
&#xD;
        2. Depression measured using the Beck Depression Inventory (BDI-II) Secondary outcome&#xD;
           measures&#xD;
&#xD;
      At baseline and 12 weeks:&#xD;
&#xD;
        1. Mental health measured using:&#xD;
&#xD;
           1.1. Overall Anxiety Severity and Impairment Scale (OASIS) 1.2. Overall Depression&#xD;
           Severity and Impairment Scale (ODSIS) 1.3. Positive and Negative Affect Scale (PANAS)&#xD;
&#xD;
        2. Quality of life measured using the qolwbref questionnaire) Eligibility Participant&#xD;
           inclusion criteria&#xD;
&#xD;
      1. 18 years or older 2. Ability to understand and read Persian or Pashto 3. Access to&#xD;
      Internet at home and having an email address 4. Meeting the DSM-IV diagnostic criteria for ED&#xD;
      (MDD, DD, MDNOS, PD, A, SAD, GAD, ADNOS, OCD) 5. Providing written, informed consent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Beck anxiety inventory</measure>
    <time_frame>Baseline</time_frame>
    <description>This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week. Each item is rated from 0 to 3 (i.e. not at all, mildly, moderately, severely), added together to obtain a maximum score of 63. The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity . Cronbach's alpha for the BAI in the present study was excellent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck anxiety inventory</measure>
    <time_frame>12 weeks after basel8ne</time_frame>
    <description>This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week. Each item is rated from 0 to 3 (i.e. not at all, mildly, moderately, severely), added together to obtain a maximum score of 63. The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity . Cronbach's alpha for the BAI in the present study was excellent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck anxiety inventory</measure>
    <time_frame>Three month follow up</time_frame>
    <description>This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week. Each item is rated from 0 to 3 (i.e. not at all, mildly, moderately, severely), added together to obtain a maximum score of 63. The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity . Cronbach's alpha for the BAI in the present study was excellent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Anxiety Severity and Impairment Scale (OASIS)</measure>
    <time_frame>12 weeks after baseline</time_frame>
    <description>he OASIS is a 5-item self-report scale that evaluates the frequency and severity of anxiety symptoms, the functional impairment related to these symptoms (i.e. school, work, home, or social impairment), and behavioral avoidance. Each item instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20. Previous studies have shown high internal consistency.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Depression Severity and Impairment Scale (ODSIS</measure>
    <time_frame>Baseline</time_frame>
    <description>.The Overall Depression Severity and Impairment Scale (ODSIS; Bentley et al., 2014) is a 5-item self-report measure that was designed for assessing the frequency and intensity of depression symptoms, the functional impairment related to these depressive symptoms, as well as behavioral avoidance across emotional disorders. Each item of the ODSIS instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional style questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale. Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always). Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional style questionnaire</measure>
    <time_frame>12 weeks after baseline</time_frame>
    <description>Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale. Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always). Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional style questionnaire</measure>
    <time_frame>Three month follow up</time_frame>
    <description>Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale. Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always). Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difficulties in Emotion Regulation Scale (DERS-16)</measure>
    <time_frame>Baseline, :</time_frame>
    <description>Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items). As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always). Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difficulties in Emotion Regulation Scale (DERS-16)</measure>
    <time_frame>12 weeks after baseline</time_frame>
    <description>Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items). As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always). Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difficulties in Emotion Regulation Scale (DERS-16)</measure>
    <time_frame>Three month follow up</time_frame>
    <description>Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items). As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always). Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Positive and Negative Affect Schedule or (PANAS)</measure>
    <time_frame>12 weeks after baseline</time_frame>
    <description>The Positive and Negative Affect Schedule or (PANAS) is a scale that consists of different words that describe feelings and emotions.The PANAS is designed around 20 items of affect. The scale is comprised of several words that describe different emotions and feelings. (Magyar-Moe, 2009).Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. (Watson, D., Clark, L. A., &amp; Tellegan, A., 1988).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Positive and Negative Affect Schedule or (PANAS)</measure>
    <time_frame>Three months follow up</time_frame>
    <description>The Positive and Negative Affect Schedule or (PANAS) is a scale that consists of different words that describe feelings and emotions.The PANAS is designed around 20 items of affect. The scale is comprised of several words that describe different emotions and feelings. (Magyar-Moe, 2009).Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. (Watson, D., Clark, L. A., &amp; Tellegan, A., 1988).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Depressive Symptoms</condition>
  <condition>Anxiety</condition>
  <condition>Emotional Problem</condition>
  <arm_group>
    <arm_group_label>Exprimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The unified protocol modules are as follows:&#xD;
Module 1: Setting the treatment goals and motivation augmentation Module 2: Using psychoeducation to learn the function of emotions and their development Module 3: Mindful (present-focused and non-judgmental) emotional awareness- Core module Module 4: Cognitive flexibility- Core module Module 5: Identifying and countering emotional avoidance behaviors- core module Module 6: Increasing awareness and confronting physical sensations/ interoceptive sensitivity- core module Module 7: Both situational and interoceptive emotion-focused exposures- Core module Module 8: Recognizing accomplishments and looking to the future (relapse prevention)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as usual care, Recieve consulting not included unified protocol Recieve supportive cares</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>UP</intervention_name>
    <description>The unified protocol modules are as follows:&#xD;
Module 1: Setting the treatment goals and motivation augmentation Module 2: Using psychoeducation to learn the function of emotions and their development Module 3: Mindful (present-focused and non-judgmental) emotional awareness- Core module Module 4: Cognitive flexibility- Core module Module 5: Identifying and countering emotional avoidance behaviors- core module Module 6: Increasing awareness and confronting physical sensations/ interoceptive sensitivity- core module Module 7: Both situational and interoceptive emotion-focused exposures- Core module Module 8: Recognizing accomplishments and looking to the future (relapse prevention)</description>
    <arm_group_label>Exprimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Diagnostic test. Psychoeducation Supoortive care</description>
    <arm_group_label>Treatment as usual</arm_group_label>
    <other_name>TAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Ability to understand and read Persian or Pashto&#xD;
&#xD;
          -  Access to Internet at home and having an email address&#xD;
&#xD;
          -  Meeting the DSM-IV diagnostic criteria for ED (MDD, DD, MDNOS, PD, A, SAD, GAD, ADNOS,&#xD;
             OCD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffering from a severe mental disorder (schizophrenia, bipolar disorder, and alcohol&#xD;
             and/or substance dependence disorder)&#xD;
&#xD;
          -  The presence of a high risk of suicide&#xD;
&#xD;
          -  other chronic or Medical disease/condition that prevents the participant&#xD;
&#xD;
          -  receiving another psychological treatment during the last six month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Internet</name>
      <address>
        <city>Bamyan</city>
        <country>Afghanistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Afghanistan</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bamyan University</investigator_affiliation>
    <investigator_full_name>Mohamad hasan yousefi</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Planned publication in a high-impact peer-reviewed journal.&#xD;
IPD sharing statement:&#xD;
The datasets generated during and/or analysed during the current study are available from the corresponding</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Between July 2022 to December 2022</ipd_time_frame>
    <ipd_access_criteria>Resonable request via academic email</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04498949
org study id: Unified Protocol
nct id: NCT04498949
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background and study aims Depression is more prevalent in younger populations. The age of
      first onset of depression has become younger, yet many adolescents with depressive symptoms
      remain untreated. Rates of anxiety and depression are increasing among children and young
      people.postsecondary education also represents a peak onset period for the occurrence of
      mental disorders. It is estimated that 12-46% of all university students are affected by
      mental health disorders in any given year. Who can participate? Afghan students over 18 years
      old fluent in Persian or Pashto, and access to an internet connection. What does the study
      involve? Participants will be randomly allocated to receive training in skills and coping
      strategies which are useful in stressful conditions.
Condition Depressive symptoms, anxiety symptom, emotional problems Interventions Participants
      in experimental group Receive 12 weeks training according to the guideline below Participants
      in control Receive treatment as usual, also the experts will respond to their questions. The
      unified protocol can track its basis from cognitive-behavioral therapy approaches. As in the
      traditional CBT approaches, the unified protocol has several modules whose base is the
      emotions . The modules focus on increasing awareness of interaction and the function of the
      model of emotion components which include thoughts, physical sensations, and behaviors. The
      final bit of the unified protocol is to change the components to a present moment awareness.
      The unified protocol is used to treat different emotional disorders unlike the traditional
      CBT approaches. This is done by targeting the underlying mechanisms that form part of all
      emotional disorders. The 5 core skills above are delivered to patients through five core
      modules. Before the key modules, there are 2 modules for introduction and learning about
      emotions. After the 5 core modules there is a module for treatment progress appraisal and
      making plans to prevent relapse.

      The unified protocol modules are as follows:

      Module 1: Setting the treatment goals and motivation augmentation Module 2: Using
      psychoeducation to learn the function of emotions and their development Module 3: Mindful
      (present-focused and non-judgmental) emotional awareness- Core module Module 4: Cognitive
      flexibility- Core module Module 5: Identifying and countering emotional avoidance behaviors-
      core module Module 6: Increasing awareness and confronting physical sensations/ interoceptive
      sensitivity- core module Module 7: Both situational and interoceptive emotion-focused
      exposures- Core module Module 8: Recognizing accomplishments and looking to the future
      (relapse prevention) Primary outcome measure

      At baseline and 12 weeks:

        1. Anxiety measured using the Beck Anxiety Inventory (BAI)

        2. Depression measured using the Beck Depression Inventory (BDI-II) Secondary outcome
           measures

      At baseline and 12 weeks:

        1. Mental health measured using:

           1.1. Overall Anxiety Severity and Impairment Scale (OASIS) 1.2. Overall Depression
           Severity and Impairment Scale (ODSIS) 1.3. Positive and Negative Affect Scale (PANAS)

        2. Quality of life measured using the qolwbref questionnaire) Eligibility Participant
           inclusion criteria

      1. 18 years or older 2. Ability to understand and read Persian or Pashto 3. Access to
      Internet at home and having an email address 4. Meeting the DSM-IV diagnostic criteria for ED
      (MDD, DD, MDNOS, PD, A, SAD, GAD, ADNOS, OCD) 5. Providing written, informed consent
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Beck anxiety inventory
time frame: Baseline
description: This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week. Each item is rated from 0 to 3 (i.e. not at all, mildly, moderately, severely), added together to obtain a maximum score of 63. The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity . Cronbach's alpha for the BAI in the present study was excellent
measure: Beck anxiety inventory
time frame: 12 weeks after basel8ne
description: This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week. Each item is rated from 0 to 3 (i.e. not at all, mildly, moderately, severely), added together to obtain a maximum score of 63. The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity . Cronbach's alpha for the BAI in the present study was excellent
measure: Beck anxiety inventory
time frame: Three month follow up
description: This is a 21-item self-report questionnaire for the measurement of anxiety symptoms experienced during the past week. Each item is rated from 0 to 3 (i.e. not at all, mildly, moderately, severely), added together to obtain a maximum score of 63. The BAI has demonstrated good to excellent internal consistency in prior validations of the scale (.85-.94), as well as adequate convergent and divergent validity . Cronbach's alpha for the BAI in the present study was excellent
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
time frame: 12 weeks after baseline
description: he OASIS is a 5-item self-report scale that evaluates the frequency and severity of anxiety symptoms, the functional impairment related to these symptoms (i.e. school, work, home, or social impairment), and behavioral avoidance. Each item instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20. Previous studies have shown high internal consistency.
measure: Overall Depression Severity and Impairment Scale (ODSIS
time frame: Baseline
description: .The Overall Depression Severity and Impairment Scale (ODSIS; Bentley et al., 2014) is a 5-item self-report measure that was designed for assessing the frequency and intensity of depression symptoms, the functional impairment related to these depressive symptoms, as well as behavioral avoidance across emotional disorders. Each item of the ODSIS instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4 and can be summed to obtain a total score ranging from 0 to 20.
measure: Emotional style questionnaire
time frame: baseline
description: Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale. Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always). Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.
measure: Emotional style questionnaire
time frame: 12 weeks after baseline
description: Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale. Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always). Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.
measure: Emotional style questionnaire
time frame: Three month follow up
description: Emotional style questionnaire consists of 24 items that assess the following dimensions of emotional wellbeing: resilience, outlook; self-awareness, sensitivity to context; social intuition, and attention four item for each sub-scale. Respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 7 (almost always). Total scores can range from 24 to 168, with higher scores reflecting greater levels of emotional wellbeing.
measure: Difficulties in Emotion Regulation Scale (DERS-16)
time frame: Baseline, :
description: Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items). As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always). Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.
measure: Difficulties in Emotion Regulation Scale (DERS-16)
time frame: 12 weeks after baseline
description: Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items). As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always). Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.
measure: Difficulties in Emotion Regulation Scale (DERS-16)
time frame: Three month follow up
description: Difficulties in Emotion Regulation Scale (DERS-16) consists of 16 items that assess the following dimensions of emotion regulation difficulties: nonacceptance of negative emotions (three items), inability to engage in goal-directed behaviors when distressed (three items), difficulties controlling impulsive behaviors when distressed (three items), limited access to emotion regulation strategies perceived as effective (five items), and lack of emotional clarity (two items). As with the original DERS, respondents rate the extent to which each item applies to them on a 5-point Likert-type scale from 1 (almost never) to 5 (almost always). Total scores on the DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.
measure: The Positive and Negative Affect Schedule or (PANAS)
time frame: 12 weeks after baseline
description: The Positive and Negative Affect Schedule or (PANAS) is a scale that consists of different words that describe feelings and emotions.The PANAS is designed around 20 items of affect. The scale is comprised of several words that describe different emotions and feelings. (Magyar-Moe, 2009).Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. (Watson, D., Clark, L. A., & Tellegan, A., 1988).
measure: The Positive and Negative Affect Schedule or (PANAS)
time frame: Three months follow up
description: The Positive and Negative Affect Schedule or (PANAS) is a scale that consists of different words that describe feelings and emotions.The PANAS is designed around 20 items of affect. The scale is comprised of several words that describe different emotions and feelings. (Magyar-Moe, 2009).Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. (Watson, D., Clark, L. A., & Tellegan, A., 1988).
arm group label: Exprimental
arm group type: Experimental
description: The unified protocol modules are as follows:
Module 1: Setting the treatment goals and motivation augmentation Module 2: Using psychoeducation to learn the function of emotions and their development Module 3: Mindful (present-focused and non-judgmental) emotional awareness- Core module Module 4: Cognitive flexibility- Core module Module 5: Identifying and countering emotional avoidance behaviors- core module Module 6: Increasing awareness and confronting physical sensations/ interoceptive sensitivity- core module Module 7: Both situational and interoceptive emotion-focused exposures- Core module Module 8: Recognizing accomplishments and looking to the future (relapse prevention)
arm group label: Treatment as usual
arm group type: Active Comparator
description: Treatment as usual care, Recieve consulting not included unified protocol Recieve supportive cares
intervention type: Behavioral
intervention name: UP
description: The unified protocol modules are as follows:
Module 1: Setting the treatment goals and motivation augmentation Module 2: Using psychoeducation to learn the function of emotions and their development Module 3: Mindful (present-focused and non-judgmental) emotional awareness- Core module Module 4: Cognitive flexibility- Core module Module 5: Identifying and countering emotional avoidance behaviors- core module Module 6: Increasing awareness and confronting physical sensations/ interoceptive sensitivity- core module Module 7: Both situational and interoceptive emotion-focused exposures- Core module Module 8: Recognizing accomplishments and looking to the future (relapse prevention)
arm group label: Exprimental
intervention type: Other
intervention name: Treatment as usual
description: Diagnostic test. Psychoeducation Supoortive care
arm group label: Treatment as usual
other name: TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Afghanistan
responsible party type: Sponsor-Investigator
investigator affiliation: Bamyan University
investigator full name: Mohamad hasan yousefi
investigator title: PhD student
mesh term: Depression
sharing ipd: Yes
ipd description: Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding
ipd info type: Clinical Study Report (CSR)
ipd time frame: Between July 2022 to December 2022
ipd access criteria: Resonable request via academic email