DepressionWCBTNCT06158763
Development and Evaluation of a CBT-based Transdiagnostic Transcultural Web App for Mental Health Problems
A study testing Web-based CBT guided self-help Interventions in people with Depression and Anxiety, run by Pakistan Association of Cognitive Therapists at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Web-based CBT guided self-help Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Association of Cognitive Therapists
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read the 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
- Being tested
- Web-based CBT guided self-help Interventions
- Keywords
- CBT, web application, depression, anxiety, self-help manual
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based CBT guided self-help InterventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In the experimental group, a web-based application intervention will be provided. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Nov 2021
- Primary completion31 Jan 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Association of Cognitive Therapists
- Sponsor type
- University, hospital or other
- Collaborators
- World Psychiatric Association (WPA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158763
- Sponsor's protocol ID
- PACTwCBT
- Acronym
- WCBT
- Status last verified
- Nov 2025
- First submitted
- 1 Sep 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a CBT-based Transdiagnostic Transcultural Web App for Mental Health Problems in Low and Middle-income Countries.
- ClinicalTrials.gov ID
- NCT06158763
- Acronym / sponsor ID
- WCBT / PACTwCBT
- Conditions
- Depression, Anxiety
- Keywords
- CBT, web application, depression, anxiety, self-help manual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pakistan Association of Cognitive TherapistsUniversity, hospital or other
- Collaborators
- World Psychiatric Association (WPA)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Web-based CBT guided self-help InterventionsIn the experimental group, a web-based application intervention will be provided. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based CBT guided self-help InterventionsAn 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. | Behavioural | Experimental Group |
Primary outcome
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.
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.
2 secondary outcomes
Clinical Measures
Time frame: 12 weeks
The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based CBT guided self-help Interventions in people with Depression and Anxiety, run by Pakistan Association of Cognitive Therapists at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of CBT-based transcultural, transdiagnostic interactive web app will be assessed (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.