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

NCT06158763 | Completed DMC

• 1 other identifier: PACTwCBT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

CBT; web application; depression; anxiety; self-help manual

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Clinical Measures

  12 weeks

• The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

  12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: Web-based CBT guided self-help Interventions

Control Group

NO INTERVENTION

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

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Association of Cognitive Therapists: lead
• World Psychiatric Association (WPA): collaborator

Study Sites (1)

Pakistan Association of Cognitive Therapists

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: December 6, 2023
• Study Start: November 1, 2021
• Primary Completion: January 31, 2024
• Study Completion: October 1, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

PA (1)