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

November 28, 2023 updated by: Pakistan Association of Cognitive Therapists

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Pakistan Association of Cognitive Therapists
        • Contact:
        • Principal Investigator:
          • Farooq Naeem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
In the experimental group, a web-based application intervention will be provided.
Behavioral: Web-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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Association of Cognitive Therapists

Collaborators

World Psychiatric Association (WPA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

February 15, 2024

Study Registration Dates

First Submitted

September 1, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACTwCBT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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