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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Evaluation of a CBT-based Transdiagnostic Transcultural Web App for Mental Health Problems in Low and Middle-income Countries.

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Web-based CBT guided self-help Interventions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be a randomized controlled trial to evaluate the feasibility and acceptability of delivering a new intervention. Participants who meet the inclusion criteria will be randomly allocated to intervention or control groups in a 1:1 ratio.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>In the experimental group, a web-based application intervention will be provided. | Behavioral: Web-based CBT guided self-help Interventions<br>* An existing CBT-based transdiagnostic self-help manual (Naeem et al., 2014) that has been used successfully in RCTs (Amin et al., 2020; Naeem et al., 2014) and has been used as an online intervention (http://khushiorkhatoon.com/) will be further adapted. The intervention consists of seven modules, including cognitive restructuring, problem-solving and behavioural activation.<br>|
| No Intervention: Control Group<br>In the control group, the patients screened for depression or anxiety received treatment as usual (TAU). TAU consisted of standard care under the responsible family physician. TAU in low-income countries largely consists of pharmacological treatment with anti-depressant medication and follow-up in an outpatient clinic. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Measures | 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. | 12 weeks | 
| The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, web application, depression, anxiety, self-help manual