Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults

Depression Clinical Trial

Official title:

Unified Protocol for Transdiagnostic Treatment: An Adaptation and Pilot RCT for the Treatment of Depression and Anxiety in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002087
• Other study ID #: 0988/Ethic/01/S3H/083/DBS
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: National University of Science and Technology, Pakistan
• Contact: Asma Nisa
• Phone: 92-345-5205498
• Email: asma.phdp19s3h[@]s3h.nust.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Pakistan	National University of Sciences and Technology, Pakistan	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
National University of Science and Technology, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5, the Research Version	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.	14 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Acceptability of randomization	The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.	14 weeks
Primary	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
Primary	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
Primary	Feasibility of outcome measures	Feasibility of outcome measures will be assessed through the assessment completion rates by participants.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks
Secondary	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.	14 weeks