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/NCT06002087</url>
    </required_header>
    <id_info>
      <org_study_id>0988/Ethic/01/S3H/083/DBS</org_study_id>
      <nct_id>NCT06002087</nct_id>
    </id_info>
    <brief_title>Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults</brief_title>
    <official_title>Unified Protocol for Transdiagnostic Treatment: An Adaptation and Pilot RCT for the Treatment of Depression and Anxiety in Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National University of Science and Technology, Pakistan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National University of Science and Technology, Pakistan</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>
        To conduct a pilot randomized controlled trial (RCT) of a culturally adapted Unified Protocol&#xD;
        (UP) for transdiagnostic psychological treatment in adults (age 18 and above) with anxiety&#xD;
        and/or depression to assess the feasibility and acceptability of UP treatment.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. To assess the estimates of likely recruitment rates including how many approached,&#xD;
             volunteered, screened, retained, and complete the treatment and what is the dropout&#xD;
             rate?&#xD;
  &#xD;
          2. To what degree do participants adhere and engage with the treatment procedures?&#xD;
  &#xD;
          3. To what extent do the participants feel satisfied with the treatment?&#xD;
  &#xD;
          4. To what degree do participants complete self-report and clinician-administered measures&#xD;
             of anxiety, depression, functional impairment, and emotion regulation?&#xD;
  &#xD;
          5. What is the treatment outcome with regard to emotion regulation, symptoms of anxiety,&#xD;
             depression, functional impairment, and emotion regulation?&#xD;
  &#xD;
        The participants will be randomized to either the treatment group or the control group. The&#xD;
        treatment group will receive 14 sessions of one-on-one individual treatment with the Unified&#xD;
        Protocol. The control group will receive no treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Most patients with depression and anxiety in low-resource settings don't get evidence-based&#xD;
        treatment. Transdiagnostic approaches like UP are promising for these settings because they&#xD;
        are multi-problem, modular, flexible, and have low complexity. The present study aimed to&#xD;
        investigate the initial acceptability and feasibility of the adapted Unified Protocol (UP) in&#xD;
        relation to its quantitative and qualitative effects on attendance, homework compliance,&#xD;
        satisfaction, and perceived usefulness of the intervention. Additionally, the study aimed to&#xD;
        evaluate the preliminary effects of the adapted UP on depression, anxiety, functional&#xD;
        impairment, and emotion regulation among adults suffering from anxiety, depression, and/or&#xD;
        comorbidity of both disorders.&#xD;
  &#xD;
        A sample size of approximately 50 adults will be recruited from mental health facilities and&#xD;
        online dissemination of the study. After screening through the Beck Depression Inventory-II&#xD;
        (BDI-II) and Beck Anxiety Inventory (BAI), and assessing the inclusion and exclusion&#xD;
        criteria, those who demonstrate moderate to severe scores on the BDI-II and BAI will be&#xD;
        further evaluated by the principal investigator using the Structured Clinical Interviews for&#xD;
        DSM-5 (Research Version) (SCID-5-RV) to determine their diagnosis. Once the eligibility&#xD;
        criteria are met, participants will be randomly assigned to one of two study conditions:&#xD;
  &#xD;
        Experimental group: Participants in the experimental group will receive the Unified Protocol&#xD;
        (UP) treatment.&#xD;
  &#xD;
        Control group: Participants in the control group will be placed on a waitlist and will not&#xD;
        receive any treatment until the end of the study.&#xD;
  &#xD;
        Participants from both groups will complete several assessment measures at baseline,&#xD;
        mid-treatment (only at week 7 of the UP), and post-treatment.&#xD;
  &#xD;
        To ensure protocol quality and fidelity, the therapist has a master's degree in Clinical&#xD;
        Psychology and two years of previous supervised clinical experience in cognitive behavioral&#xD;
        therapy (CBT). The therapist also participated in introductory and intermediate-level&#xD;
        training workshops for the Unified Protocol (UP) and received UP Therapist Certification. The&#xD;
        therapist has received supervision from the UP-certified psychologist and received 18 weeks&#xD;
        of individualized supervision on a course of treatment utilizing the UP. Weekly supervision&#xD;
        sessions were conducted via video-conferencing (Zoom), and transcripts of the sessions were&#xD;
        reviewed for adherence to the protocol and competence in protocol delivery throughout the&#xD;
        course of treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Experimental group: Participants in the experimental group will receive the Unified Protocol (UP) treatment.&#xD;
  Control group: Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>To ensure blinding of participants and intervention facilitator, a randomizing researcher, who is different from the facilitator, will generate the sequences and assign an ID (1-50) to one of the groups based on the sequence. The sealed envelopes will be given to the facilitator, who will open the envelope in the interview and inform the participants about their allocated group. This will ensure that neither the participants nor the facilitator will know which group they are assigned to, which will help to minimize bias in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility- Recruitment method</measure>
      <time_frame>14 weeks</time_frame>
      <description>The number of participants recruited by each of the three methods used for recruiting. The methods will be: mental health facilities, online dissemination, and referrals and recommendations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility- Recruitment rate</measure>
      <time_frame>14 weeks</time_frame>
      <description>To assess the estimates of likely recruitment rates, including:&#xD;
  How many participants approached? How many participants volunteered? How many participants were screened? How many participants were retained in the study? What was the dropout rate? The number of participants completing the final assessment (assessed through a record made at each session).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility- Weekly face-to-face sessions</measure>
      <time_frame>14 weeks</time_frame>
      <description>The nature of barriers that may lead to participants dropping out of treatment can be assessed by examining the number and type of problems that they experienced while attending weekly sessions. These problems include transportation difficulties, work or educational demands, childcare difficulties, scheduling conflicts, and treatment procedures interfering with daily life. Followed by an open-ended question that will assess any other reason to discontinue the treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility: Eligibility criteria</measure>
      <time_frame>14 weeks</time_frame>
      <description>Assessed through the number of participants fulfilling the eligibility criteria from the total number of participants registered, number of ineligible participants, and reasons for ineligibility.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility - Treatment adherence and engagement</measure>
      <time_frame>14 weeks</time_frame>
      <description>Engagement in treatment will be assessed using the Homework Rating Scale-Revised, a 12-item measure that assesses beliefs, consequences, and engagement with treatment homework activities. Total scores range from 0 to 48 on this scale, where higher scores indicate higher commitment to the treatment. Treatment adherence will be further assessed by tracking participant attendance, percentage of intervention completion, and number of sessions completed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility - Semi-structured Interview for treatment adherence and engagement</measure>
      <time_frame>14 weeks</time_frame>
      <description>Semi-structured questions will be asked by an independent interviewer to assess the reasons for adherence and non-adherence to the treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of randomization</measure>
      <time_frame>14 weeks</time_frame>
      <description>The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the treatment</measure>
      <time_frame>14 weeks</time_frame>
      <description>It will be measured through client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the treatment - Semi-structured interview</measure>
      <time_frame>14 weeks</time_frame>
      <description>Semi-structured interview by an independent interviewer will be conducted to obtain responses on a number of indicators including; Participants' overall satisfaction with the treatment, understand the overall content covered in the treatment, the perceived usefulness of the techniques learned, the discomfort it generated, the likelihood that participants would choose such a treatment again, their recommendation to friends or family, what they found most, what they find least helpful, any modifications they would recommend.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility of outcome measures</measure>
      <time_frame>14 weeks</time_frame>
      <description>Feasibility of outcome measures will be assessed through the assessment completion rates by participants.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Beck Depression Inventory-II</measure>
      <time_frame>14 weeks</time_frame>
      <description>It is a 21-item self-report questionnaire to assess depressive symptoms with scores ranging from 0 to 3. Higher scores indicate worse depressive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Beck Anxiety Inventory</measure>
      <time_frame>14 weeks</time_frame>
      <description>It is a 21-item self-report questionnaire to assess the severity of anxiety symptoms with scores ranging from 0 to 3. Higher scores indicate worse anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Work and Social Adjustment Scale</measure>
      <time_frame>14 weeks</time_frame>
      <description>It represents a simple measurement of impairment of functioning and consists of 5 items, each rated on an 8-point severity scale adding up to a maximum severity of 40 points. It is validated for use across the full spectrum of psychiatric disorders.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale</measure>
      <time_frame>14 weeks</time_frame>
      <description>It is a 36-item scale with 6 subscales that measure emotion dysregulation and emotional self-regulation strategies. The subscales are non-acceptance of emotional responses, difficulty in performing purposeful behavior, difficulty controlling impulse, lack of emotional awareness, limited access to emotion regulation strategies, and lack of clarity of emotion. The items are scored on a scale of 1 to 5, with higher scores indicating more severe difficulties in emotion regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive and Negative Affect Schedule</measure>
      <time_frame>14 weeks</time_frame>
      <description>It is a self-report measure that assesses the two broad dimensions of affect: positive affect and negative affect. It is a 20-item scale, and items are rated on a 5-point scale, with higher scores indicating higher experience of those emotions.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5, the Research Version</measure>
      <time_frame>14 weeks</time_frame>
      <description>The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 is a semi-structured interview guide for making the major Diagnostic and Statistical Manual of Mental Disorders-5 diagnoses. The current study is using this scale to ensure that all of the study subjects have symptoms that meet the DSM-5 criteria for Major Depressive Disorder and/or anxiety disorder and that all of the subjects with Substance Use Disorder, Bipolar Disorder, or Psychotic Disorders are excluded. The items are scored on a scale of 1 to 3. A higher score on this scale suggests the presence of a mental condition.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Experimental group: Unified Protocol (UP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 14 weekly individual sessions of 50-60 minutes each using the adapted UP treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group: Waitlist Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Unified Protocol for Transdiagnostic Treatment of Emotional Disorders</intervention_name>
      <description>The current researchers adapted the Unified Protocol (UP) treatment and used the adapted version in this study. UP outlines two complimentary modules for goal setting and psychoeducation followed by five core treatment modules: mindful emotion awareness, cognitive flexibility, countering emotional behaviors, awareness and tolerance of physical sensations, and emotion exposures, and an optional relapse prevention module to help people maintain their gains after treatment.</description>
      <arm_group_label>Experimental group: Unified Protocol (UP)</arm_group_label>
      <other_name>UP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18&#xD;
  &#xD;
            -  suffering from anxious and/or depressive disorder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  suicide risk at the time of assessment&#xD;
  &#xD;
            -  comorbidity of pervasive developmental disorder&#xD;
  &#xD;
            -  comorbidity of psychotic disorders&#xD;
  &#xD;
            -  severe physical illness&#xD;
  &#xD;
            -  receiving concurrent psychotherapy&#xD;
  &#xD;
            -  receiving psychopharmacological treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Salma Siddiqui</last_name>
      <role>Study Chair</role>
      <affiliation>National University of Science and Technology, Pakistan</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Amantia A. Ametaj</last_name>
      <role>Study Director</role>
      <affiliation>Harvard School of Public Health (HSPH)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Asma Nisa</last_name>
      <phone>92-345-5205498</phone>
      <email>asma.phdp19s3h@s3h.nust.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>National University of Sciences and Technology, Pakistan</name>
        <address>
          <city>Islamabad</city>
          <zip>44000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Asma Nisa</last_name>
        <phone>+92-345-5205498</phone>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 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>National University of Science and Technology, Pakistan</investigator_affiliation>
      <investigator_full_name>Asma Nisa</investigator_full_name>
      <investigator_title>Primary Researcher</investigator_title>
    </responsible_party>
    <keyword>Anxiety</keyword>
    <keyword>Depression</keyword>
    <keyword>Emotion Regulation</keyword>
    <keyword>Evidence-Based Treatment</keyword>
    <keyword>Transdiagnostic</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>Anxiety Disorders</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/NCT06002087
  org study id: 0988/Ethic/01/S3H/083/DBS
  nct id: NCT06002087
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To conduct a pilot randomized controlled trial (RCT) of a culturally adapted Unified Protocol
        (UP) for transdiagnostic psychological treatment in adults (age 18 and above) with anxiety
        and/or depression to assess the feasibility and acceptability of UP treatment.
  
        The main questions it aims to answer are:
  
          1. To assess the estimates of likely recruitment rates including how many approached,
             volunteered, screened, retained, and complete the treatment and what is the dropout
             rate?
  
          2. To what degree do participants adhere and engage with the treatment procedures?
  
          3. To what extent do the participants feel satisfied with the treatment?
  
          4. To what degree do participants complete self-report and clinician-administered measures
             of anxiety, depression, functional impairment, and emotion regulation?
  
          5. What is the treatment outcome with regard to emotion regulation, symptoms of anxiety,
             depression, functional impairment, and emotion regulation?
  
        The participants will be randomized to either the treatment group or the control group. The
        treatment group will receive 14 sessions of one-on-one individual treatment with the Unified
        Protocol. The control group will receive no treatment.
  Most patients with depression and anxiety in low-resource settings don't get evidence-based
        treatment. Transdiagnostic approaches like UP are promising for these settings because they
        are multi-problem, modular, flexible, and have low complexity. The present study aimed to
        investigate the initial acceptability and feasibility of the adapted Unified Protocol (UP) in
        relation to its quantitative and qualitative effects on attendance, homework compliance,
        satisfaction, and perceived usefulness of the intervention. Additionally, the study aimed to
        evaluate the preliminary effects of the adapted UP on depression, anxiety, functional
        impairment, and emotion regulation among adults suffering from anxiety, depression, and/or
        comorbidity of both disorders.
  
        A sample size of approximately 50 adults will be recruited from mental health facilities and
        online dissemination of the study. After screening through the Beck Depression Inventory-II
        (BDI-II) and Beck Anxiety Inventory (BAI), and assessing the inclusion and exclusion
        criteria, those who demonstrate moderate to severe scores on the BDI-II and BAI will be
        further evaluated by the principal investigator using the Structured Clinical Interviews for
        DSM-5 (Research Version) (SCID-5-RV) to determine their diagnosis. Once the eligibility
        criteria are met, participants will be randomly assigned to one of two study conditions:
  
        Experimental group: Participants in the experimental group will receive the Unified Protocol
        (UP) treatment.
  
        Control group: Participants in the control group will be placed on a waitlist and will not
        receive any treatment until the end of the study.
  
        Participants from both groups will complete several assessment measures at baseline,
        mid-treatment (only at week 7 of the UP), and post-treatment.
  
        To ensure protocol quality and fidelity, the therapist has a master's degree in Clinical
        Psychology and two years of previous supervised clinical experience in cognitive behavioral
        therapy (CBT). The therapist also participated in introductory and intermediate-level
        training workshops for the Unified Protocol (UP) and received UP Therapist Certification. The
        therapist has received supervision from the UP-certified psychologist and received 18 weeks
        of individualized supervision on a course of treatment utilizing the UP. Weekly supervision
        sessions were conducted via video-conferencing (Zoom), and transcripts of the sessions were
        reviewed for adherence to the protocol and competence in protocol delivery throughout the
        course of treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Experimental group: Participants in the experimental group will receive the Unified Protocol (UP) treatment.
  Control group: Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: To ensure blinding of participants and intervention facilitator, a randomizing researcher, who is different from the facilitator, will generate the sequences and assign an ID (1-50) to one of the groups based on the sequence. The sealed envelopes will be given to the facilitator, who will open the envelope in the interview and inform the participants about their allocated group. This will ensure that neither the participants nor the facilitator will know which group they are assigned to, which will help to minimize bias in the study.
  measure: Feasibility- Recruitment method
  time frame: 14 weeks
  description: The number of participants recruited by each of the three methods used for recruiting. The methods will be: mental health facilities, online dissemination, and referrals and recommendations.
  measure: Feasibility- Recruitment rate
  time frame: 14 weeks
  description: To assess the estimates of likely recruitment rates, including:
  How many participants approached? How many participants volunteered? How many participants were screened? How many participants were retained in the study? What was the dropout rate? The number of participants completing the final assessment (assessed through a record made at each session).
  measure: Feasibility- Weekly face-to-face sessions
  time frame: 14 weeks
  description: The nature of barriers that may lead to participants dropping out of treatment can be assessed by examining the number and type of problems that they experienced while attending weekly sessions. These problems include transportation difficulties, work or educational demands, childcare difficulties, scheduling conflicts, and treatment procedures interfering with daily life. Followed by an open-ended question that will assess any other reason to discontinue the treatment.
  measure: Feasibility: Eligibility criteria
  time frame: 14 weeks
  description: Assessed through the number of participants fulfilling the eligibility criteria from the total number of participants registered, number of ineligible participants, and reasons for ineligibility.
  measure: Feasibility - Treatment adherence and engagement
  time frame: 14 weeks
  description: Engagement in treatment will be assessed using the Homework Rating Scale-Revised, a 12-item measure that assesses beliefs, consequences, and engagement with treatment homework activities. Total scores range from 0 to 48 on this scale, where higher scores indicate higher commitment to the treatment. Treatment adherence will be further assessed by tracking participant attendance, percentage of intervention completion, and number of sessions completed.
  measure: Feasibility - Semi-structured Interview for treatment adherence and engagement
  time frame: 14 weeks
  description: Semi-structured questions will be asked by an independent interviewer to assess the reasons for adherence and non-adherence to the treatment.
  measure: Acceptability of randomization
  time frame: 14 weeks
  description: The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.
  measure: Acceptability of the treatment
  time frame: 14 weeks
  description: It will be measured through client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
  measure: Acceptability of the treatment - Semi-structured interview
  time frame: 14 weeks
  description: Semi-structured interview by an independent interviewer will be conducted to obtain responses on a number of indicators including; Participants' overall satisfaction with the treatment, understand the overall content covered in the treatment, the perceived usefulness of the techniques learned, the discomfort it generated, the likelihood that participants would choose such a treatment again, their recommendation to friends or family, what they found most, what they find least helpful, any modifications they would recommend.
  measure: Feasibility of outcome measures
  time frame: 14 weeks
  description: Feasibility of outcome measures will be assessed through the assessment completion rates by participants.
  measure: Beck Depression Inventory-II
  time frame: 14 weeks
  description: It is a 21-item self-report questionnaire to assess depressive symptoms with scores ranging from 0 to 3. Higher scores indicate worse depressive symptoms.
  measure: Beck Anxiety Inventory
  time frame: 14 weeks
  description: It is a 21-item self-report questionnaire to assess the severity of anxiety symptoms with scores ranging from 0 to 3. Higher scores indicate worse anxiety symptoms.
  measure: Work and Social Adjustment Scale
  time frame: 14 weeks
  description: It represents a simple measurement of impairment of functioning and consists of 5 items, each rated on an 8-point severity scale adding up to a maximum severity of 40 points. It is validated for use across the full spectrum of psychiatric disorders.
  measure: Difficulties in Emotion Regulation Scale
  time frame: 14 weeks
  description: It is a 36-item scale with 6 subscales that measure emotion dysregulation and emotional self-regulation strategies. The subscales are non-acceptance of emotional responses, difficulty in performing purposeful behavior, difficulty controlling impulse, lack of emotional awareness, limited access to emotion regulation strategies, and lack of clarity of emotion. The items are scored on a scale of 1 to 5, with higher scores indicating more severe difficulties in emotion regulation.
  measure: Positive and Negative Affect Schedule
  time frame: 14 weeks
  description: It is a self-report measure that assesses the two broad dimensions of affect: positive affect and negative affect. It is a 20-item scale, and items are rated on a 5-point scale, with higher scores indicating higher experience of those emotions.
  measure: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5, the Research Version
  time frame: 14 weeks
  description: The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 is a semi-structured interview guide for making the major Diagnostic and Statistical Manual of Mental Disorders-5 diagnoses. The current study is using this scale to ensure that all of the study subjects have symptoms that meet the DSM-5 criteria for Major Depressive Disorder and/or anxiety disorder and that all of the subjects with Substance Use Disorder, Bipolar Disorder, or Psychotic Disorders are excluded. The items are scored on a scale of 1 to 3. A higher score on this scale suggests the presence of a mental condition.
  arm group label: Experimental group: Unified Protocol (UP)
  arm group type: Experimental
  description: Participants will receive 14 weekly individual sessions of 50-60 minutes each using the adapted UP treatment.
  arm group label: Control group: Waitlist Control
  arm group type: No Intervention
  description: Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.
  intervention type: Behavioral
  intervention name: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
  description: The current researchers adapted the Unified Protocol (UP) treatment and used the adapted version in this study. UP outlines two complimentary modules for goal setting and psychoeducation followed by five core treatment modules: mindful emotion awareness, cognitive flexibility, countering emotional behaviors, awareness and tolerance of physical sensations, and emotion exposures, and an optional relapse prevention module to help people maintain their gains after treatment.
  arm group label: Experimental group: Unified Protocol (UP)
  other name: UP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Salma Siddiqui
  role: Study Chair
  affiliation: National University of Science and Technology, Pakistan
  last name: Amantia A. Ametaj
  role: Study Director
  affiliation: Harvard School of Public Health (HSPH)
  last name: Asma Nisa
  phone: 92-345-5205498
  email: asma.phdp19s3h@s3h.nust.edu.pk
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: National University of Science and Technology, Pakistan
  investigator full name: Asma Nisa
  investigator title: Primary Researcher
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders
  sharing ipd: No