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

NCT ID: NCT06158763

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2024-10-01

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental Group

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

Group Type: EXPERIMENTAL

Web-based CBT guided self-help Interventions

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Psychiatric Association (WPA)

UNKNOWN

Sponsor Role: collaborator

Pakistan Association of Cognitive Therapists

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pakistan Association of Cognitive Therapists

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

PACTwCBT

Identifier Type: -

Identifier Source: org_study_id