Development and Evaluation of a CBT-based Transdiagnostic Transcultural Web App for Mental Health Problems

Not Applicable

Recruiting

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Web-based CBT guided self-help Interventions

• Registration Number: NCT06158763
• Lead Sponsor: Pakistan Association of Cognitive Therapists

Brief Summary

This study aims to (1) develop a CBT-based transcultural, transdiagnostic interactive web app and (2) assess the feasibility, acceptability, and preliminary efficacy of this intervention.

Detailed Description

Three-quarters of the global burden of mental disorders, including depression and anxiety, lies in low and middle-income countries (LMICs) (WHO, 2017). However, the treatment gap for common mental disorders in LMICs is significant, with an estimated 90% of people in these settings unable to access appropriate mental health care (Vos et al., 2015).

Despite the strong evidence supporting effectiveness in several disorders, cognitive behaviour therapy (CBT) remains underutilized internationally due to the limited availability of comprehensive training programmes and qualified CBT-trained staff. (Myhr \& Payne, 2006). However, self-help and GSH can be delivered online and have been found to be effective and feasible for individuals with depression and anxiety (Andrews et al., 2018). Furthermore, leveraging the unprecedented increase in cell phone users and internet technologies, as well as the decline in prices of handheld mobile devices, may overcome barriers to care and address the substantial mental health treatment gap in these settings (Lambert \& Littlefield, 2009; Lewis et al., 2012; UN Foundation-Vodafone Foundation Partnership, 2020; WHO, 2011). We, therefore, propose the development and evaluation of a CBT-based transcultural, transdiagnostic interactive web app to address symptoms of depression, anxiety and stress.

Study Timeline

• Study First Submitted: 2023-09-01
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Study Start: 2023-12-01
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-01-31
• Study Completion: 2024-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Individuals aged 18 to 65 years
• At least 5 years of education
• Computer literate
• Owning a smartphone or a personal computer with a reliable internet connection
• Score of 8 or higher on Hospital Anxiety and Depression Scale-Depression or Anxiety scales as measured by their primary care clinician.

Exclusion Criteria

• Substance use disorder according to DSM-5 criteria
• Significant cognitive impairment (for example, profound learning disability or dementia)
• Active psychosis as determined by their primary care clinician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	Web-based CBT guided self-help Interventions	In the experimental group, a web-based application intervention will be provided.

Primary Outcome Measures

Name	Time	Method
Acceptability of CBT-based transcultural, transdiagnostic interactive web app will be assessed	12 weeks	Acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants.
Feasibility of CBT-based transcultural, transdiagnostic interactive web app will be assessed	12 weeks	Feasibility \\will be assessed through trial procedure, recruitment, retention and informal feedback from participants.

Secondary Outcome Measures

Name	Time	Method
Clinical Measures	12 weeks	The Hospital Anxiety and Depression Scale (HADS) will be used to measure Anxiety and Depression. The HADS is a rating scale consisting of 14 items, Each of the items is scored on a 4-point Likert scale from 0 (not present) to 3 (considerable). The sum of the individual items provides subscale scores on the HADS-D and the HADS-A, which may range between 0 and 21. A cut-off point of ≥8 for each of the constituent subscales is used to indicate probable caseness.
The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	12 weeks	The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) will measure the functioning and disability. It covers 6 Domains, the scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed.

Trial Locations

Locations (1)

Pakistan Association of Cognitive Therapists; 🇵🇰 Lahore, Punjab, Pakistan