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Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Sponsored by
National University of Science and Technology, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Anxiety, Depression, Emotion Regulation, Evidence-Based Treatment, Transdiagnostic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 suffering from anxious and/or depressive disorder Exclusion Criteria: suicide risk at the time of assessment comorbidity of pervasive developmental disorder comorbidity of psychotic disorders severe physical illness receiving concurrent psychotherapy receiving psychopharmacological treatment

Sites / Locations

  • National University of Sciences and Technology, PakistanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group: Unified Protocol (UP)

Control group: Waitlist Control

Arm Description

Participants will receive 14 weekly individual sessions of 50-60 minutes each using the adapted UP treatment.

Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.

Outcomes

Primary Outcome Measures

Feasibility- Recruitment method
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.
Feasibility- Recruitment rate
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).
Feasibility- Weekly face-to-face sessions
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.
Feasibility: Eligibility criteria
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.
Feasibility - Treatment adherence and engagement
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.
Feasibility - Semi-structured Interview for treatment adherence and engagement
Semi-structured questions will be asked by an independent interviewer to assess the reasons for adherence and non-adherence to the treatment.
Acceptability of randomization
The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.
Acceptability of the treatment
It will be measured through client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Acceptability of the treatment - Semi-structured interview
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.
Feasibility of outcome measures
Feasibility of outcome measures will be assessed through the assessment completion rates by participants.

Secondary Outcome Measures

Beck Depression Inventory-II
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.
Beck Anxiety Inventory
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.
Work and Social Adjustment Scale
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.
Difficulties in Emotion Regulation Scale
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.
Positive and Negative Affect Schedule
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.

Full Information

First Posted
August 3, 2023
Last Updated
August 31, 2023
Sponsor
National University of Science and Technology, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT06002087
Brief Title
Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults
Official Title
Unified Protocol for Transdiagnostic Treatment: An Adaptation and Pilot RCT for the Treatment of Depression and Anxiety in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Science and Technology, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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: 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? To what degree do participants adhere and engage with the treatment procedures? To what extent do the participants feel satisfied with the treatment? To what degree do participants complete self-report and clinician-administered measures of anxiety, depression, functional impairment, and emotion regulation? 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Anxiety, Depression, Emotion Regulation, Evidence-Based Treatment, Transdiagnostic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group: Unified Protocol (UP)
Arm Type
Experimental
Arm Description
Participants will receive 14 weekly individual sessions of 50-60 minutes each using the adapted UP treatment.
Arm Title
Control group: Waitlist Control
Arm Type
No Intervention
Arm 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(s)
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Other Intervention Name(s)
UP
Intervention 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.
Primary Outcome Measure Information:
Title
Feasibility- Recruitment method
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.
Time Frame
14 weeks
Title
Feasibility- Recruitment rate
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).
Time Frame
14 weeks
Title
Feasibility- Weekly face-to-face sessions
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.
Time Frame
14 weeks
Title
Feasibility: Eligibility criteria
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.
Time Frame
14 weeks
Title
Feasibility - Treatment adherence and engagement
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.
Time Frame
14 weeks
Title
Feasibility - Semi-structured Interview for treatment adherence and engagement
Description
Semi-structured questions will be asked by an independent interviewer to assess the reasons for adherence and non-adherence to the treatment.
Time Frame
14 weeks
Title
Acceptability of randomization
Description
The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.
Time Frame
14 weeks
Title
Acceptability of the treatment
Description
It will be measured through client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Time Frame
14 weeks
Title
Acceptability of the treatment - Semi-structured interview
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.
Time Frame
14 weeks
Title
Feasibility of outcome measures
Description
Feasibility of outcome measures will be assessed through the assessment completion rates by participants.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory-II
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.
Time Frame
14 weeks
Title
Beck Anxiety Inventory
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.
Time Frame
14 weeks
Title
Work and Social Adjustment Scale
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.
Time Frame
14 weeks
Title
Difficulties in Emotion Regulation Scale
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.
Time Frame
14 weeks
Title
Positive and Negative Affect Schedule
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.
Time Frame
14 weeks
Other Pre-specified Outcome Measures:
Title
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5, the Research Version
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.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 suffering from anxious and/or depressive disorder Exclusion Criteria: suicide risk at the time of assessment comorbidity of pervasive developmental disorder comorbidity of psychotic disorders severe physical illness receiving concurrent psychotherapy receiving psychopharmacological treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asma Nisa
Phone
92-345-5205498
Email
asma.phdp19s3h@s3h.nust.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salma Siddiqui
Organizational Affiliation
National University of Science and Technology, Pakistan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amantia A. Ametaj
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Study Director
Facility Information:
Facility Name
National University of Sciences and Technology, Pakistan
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asma Nisa
Phone
+92-345-5205498

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults

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