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NCT Number: NCT06158763

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Association of Cognitive Therapists

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based CBT guided self-help Interventions

Behavioral

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.

Primary outcomes

  1. Feasibility of CBT-based transcultural, transdiagnostic interactive web app will be assessed

    Time frame: 12 weeks

    Feasibility \\will be assessed through trial procedure, recruitment, retention and informal feedback from participants.

  2. Acceptability of CBT-based transcultural, transdiagnostic interactive web app will be assessed

    Time frame: 12 weeks

    Acceptability will be assessed through trial procedure, recruitment, retention and informal feedback from participants.

Secondary outcomes

  1. Clinical Measures

    Time frame: 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.

  2. The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pakistan Association of Cognitive Therapists

Other

Collaborators

  • World Psychiatric Association (WPA)

Registry information

Official study title

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

Acronym: WCBT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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