Clinical trial NCT06002087: 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
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: Anxiety
Depression
Emotion Regulation
Evidence-Based Treatment
Transdiagnostic
Lead sponsor: National University of Science and Technology, Pakistan
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Feasibility- Recruitment method
timeFrame: 14 weeks
measure: Feasibility- Recruitment rate
timeFrame: 14 weeks
measure: Feasibility- Weekly face-to-face sessions
timeFrame: 14 weeks
measure: Feasibility: Eligibility criteria
timeFrame: 14 weeks
measure: Feasibility - Treatment adherence and engagement
timeFrame: 14 weeks
measure: Feasibility - Semi-structured Interview for treatment adherence and engagement
timeFrame: 14 weeks
measure: Acceptability of randomization
timeFrame: 14 weeks
measure: Acceptability of the treatment
timeFrame: 14 weeks
measure: Acceptability of the treatment - Semi-structured interview
timeFrame: 14 weeks
measure: Feasibility of outcome measures
timeFrame: 14 weeks
Secondary outcomes:
measure: Beck Depression Inventory-II
timeFrame: 14 weeks
measure: Beck Anxiety Inventory
timeFrame: 14 weeks
measure: Work and Social Adjustment Scale
timeFrame: 14 weeks
measure: Difficulties in Emotion Regulation Scale
timeFrame: 14 weeks
measure: Positive and Negative Affect Schedule
timeFrame: 14 weeks
Other outcomes:
measure: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5, the Research Version
timeFrame: 14 weeks
Locations:
city: Islamabad
country: Pakistan
facility: National University of Sciences and Technology, Pakistan
Study officials:
affiliation: National University of Science and Technology, Pakistan
name: Salma Siddiqui
role: STUDY_CHAIR
affiliation: Harvard School of Public Health (HSPH)
name: Amantia A. Ametaj
role: STUDY_DIRECTOR
References: