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

Depression Clinical Trial

— WCBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158763
• Other study ID #: PACTwCBT
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: November 2023
• Source: Pakistan Association of Cognitive Therapists
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 15, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Pakistan Association of Cognitive Therapists	Lahore	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Association of Cognitive Therapists	World Psychiatric Association (WPA)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	12 weeks
Secondary	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.	12 weeks