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Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults

NCT06002087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-06-29

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • National University of Science and Technology, Pakistan

    lead OTHER

Principal Investigators

  • Salma Siddiqui · National University of Science and Technology, Pakistan

  • Amantia A. Ametaj · Harvard School of Public Health (HSPH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2023-12-31
Completion
2024-03-15

Countries

  • Pakistan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002087 on ClinicalTrials.gov