Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults

NCT ID: NCT06002087

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-03-15

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. 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.

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group: Unified Protocol (UP)

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

Group Type: EXPERIMENTAL

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type: 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.

Control group: Waitlist Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

UP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Science and Technology, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Asma Nisa

Primary Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salma Siddiqui

Role: STUDY_CHAIR

National University of Science and Technology, Pakistan

Amantia A. Ametaj

Role: STUDY_DIRECTOR

Harvard School of Public Health (HSPH)

Locations

National University of Sciences and Technology, Pakistan

Islamabad, Islamabad, Pakistan

Countries

Pakistan

Other Identifiers

0988/Ethic/01/S3H/083/DBS

Identifier Type: -

Identifier Source: org_study_id