Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults

NCT06002087 | Completed

• 1 other identifier: 0988/Ethic/01/S3H/083/DBS
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.To what degree do participants adhere and engage with the treatment procedures?
3. 3.To what extent do the participants feel satisfied with the treatment?
4. 4.To what degree do participants complete self-report and clinician-administered measures of anxiety, depression, functional impairment, and emotion regulation?
5. 5.What is the treatment outcome with regard to emotion regulation, symptoms of anxiety, depression, functional impairment, and emotion regulation?

Conditions

Depression; Anxiety

Keywords

Anxiety; Depression; Emotion Regulation; Evidence-Based Treatment; Transdiagnostic

Outcome Measures

Primary Outcomes (10)

• 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.

  14 weeks

• 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).

  14 weeks

• 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.

  14 weeks

• 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.

  14 weeks

• 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.

  14 weeks

• 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.

  14 weeks

• Acceptability of randomization

  The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.

  14 weeks

• 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.

  14 weeks

• 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.

  14 weeks

• Feasibility of outcome measures

  Feasibility of outcome measures will be assessed through the assessment completion rates by participants.

  14 weeks

Secondary Outcomes (5)

• Beck Depression Inventory-II

  14 weeks

• Beck Anxiety Inventory

  14 weeks

• Work and Social Adjustment Scale

  14 weeks

• Difficulties in Emotion Regulation Scale

  14 weeks

• Positive and Negative Affect Schedule

  14 weeks

Other Outcomes (1)

• Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5, the Research Version

  14 weeks

Study Arms (2)

Experimental group: Unified Protocol (UP)

EXPERIMENTAL

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

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Control group: Waitlist Control

NO INTERVENTION

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

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders BEHAVIORAL

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.

Also known as: UP

Experimental group: Unified Protocol (UP)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18
• suffering from anxious and/or depressive disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Science and Technology, Pakistan: lead

Study Sites (1)

National University of Sciences and Technology, Pakistan

Islamabad, Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Self-Control; Social Behavior

Study Officials

• Salma Siddiqui

  National University of Science and Technology, Pakistan

  STUDY CHAIR

• Amantia A. Ametaj

  Harvard School of Public Health (HSPH)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Researcher

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 15, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)