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CompletedNCT06158763WCBTUpdated Nov 19, 2025

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

An interventional study of Web-based CBT guided self-help Interventions in Depression and Anxiety, sponsored by Pakistan Association of Cognitive Therapists. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Pakistan Association of Cognitive Therapists · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Nov 2021, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Depression
  • Anxiety

Keywords

  • CBT
  • web application
  • depression
  • anxiety
  • self-help manual
03

In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 50 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Pakistan Association of Cognitive Therapists is the lead sponsor of 13 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Experimental Group

    In the experimental group, a web-based application intervention will be provided.

    Behavioral: Web-based CBT guided self-help Interventions

  • No intervention
    Control Group

    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.

Interventions

  • BehavioralWeb-based CBT guided self-help Interventions

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Pakistan Association of Cognitive Therapists
    Lahore, Punjab Province 54000, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06158763
Lead sponsor
Pakistan Association of Cognitive Therapists
Collaborators
World Psychiatric Association (WPA)
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Nov 1, 2021
Primary completion
Jan 31, 2024
Completion
Oct 1, 2024
Last update
Nov 19, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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