Clinical trial NCT06158763: Development and Evaluation of a CBT-based Transdiagnostic Transcultural Web App for Mental Health Problems
Official title: Development and Evaluation of a CBT-based Transdiagnostic Transcultural Web App for Mental Health Problems in Low and Middle-income Countries.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: CBT
web application
depression
anxiety
self-help manual
Lead sponsor: Pakistan Association of Cognitive Therapists
Sponsor class: OTHER
Collaborators: name: World Psychiatric Association (WPA)
First posted: 2023-12-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility of CBT-based transcultural, transdiagnostic interactive web app will be assessed
timeFrame: 12 weeks
measure: Acceptability of CBT-based transcultural, transdiagnostic interactive web app will be assessed
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Measures
timeFrame: 12 weeks
measure: The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Association of Cognitive Therapists
state: Punjab
Study officials:
References: