AnxietyNCT06646900
Feasibility and Acceptability Trial of a Culturally Adapted Manual Versus Standard CBT Manual: A Randomized Control Trial
A study testing Culturally adapted CBT (CaCBT) based guided self-help manual and Standard CBT Manual in people with Anxiety and Depression, run by Pakistan Association of Cognitive Therapists at 1 site in Pakistan.
Trial summary
This randomized controlled trial (RCT) will compare the efficacy and feasibility and acceptability of a culturally adapted CBT manual with a standard CBT manual, focusing on addressing cultural factors in therapy delivery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Culturally adapted CBT (CaCBT) based guided self-help manual and Standard CBT Manual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2024to 31 Dec 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
- 5 years of education
- Symptoms of depression and anxiety
Who cannot join
- Substance use disorder according to DSM-5 criteria as determined by primary care clinician
- Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician
- Active psychosis as determined by their primary care clinician
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Association of Cognitive Therapists
Lahore, Punjab Province, 54000
Taj Magsi, 00923233914614, tajmagsi2017@gmail.com
Farooq Naeem
About this study
This randomized controlled trial (RCT) will compare the efficacy and feasibility and acceptability of a culturally adapted CBT manual with a standard CBT manual, focusing on addressing cultural factors in therapy delivery.
Read the detailed description
Randomized Controlled Trial (RCT): Participants will be randomly assigned to either the culturally adapted CBT manual group or the standard CBT manual group. A culturally adapted manual will integrate cultural values, norms, and idioms of suffering into CBT techniques, ensuring relevance and acceptance within the target cultural group. The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations.
- Conditions
- Anxiety, Depression
- Being tested
- Culturally adapted CBT (CaCBT) based guided self-help manual, Standard CBT Manual
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted CBT (CaCBT) based guided self-help manualBehavioural
The intervention consists of seven modules including cognitive restructuring, problem solving, behavioural activation and conflict management. Three additional modules focus on interpersonal relationships, mental health wellbeing and self-care. Each module is delivered over one week. The intervention uses culturally appropriate stories, drawings, examples from local folklore and religious context to describe the concepts of CBT.
Standard CBT ManualBehavioural
The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations
| Study group | Role | What they receive |
|---|---|---|
| culturally adapted CaCBT manual | Experimental | Not described Receives: Behavioral: Culturally adapted CBT (CaCBT) based guided self-help manual |
| standard CBT manual | Experimental | Not described Receives: Behavioral: Standard CBT Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability measures
Feasibility and acceptability and Client's satisfaction will be measured through standardized measures of anxiety and depression
Measured: 12 weeks
Clinical Measures
Depression and Anxiety, measured by Hosptal and Anxiety Scale (HADS)
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 posted17 Oct 2024
- Study start20 Nov 2024 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Association of Cognitive Therapists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646900
- Sponsor's protocol ID
- PACTMN24
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Trial of a Culturally Adapted Manual Versus Standard CBT Manual: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06646900
- Acronym / sponsor ID
- PACTMN24
- Conditions
- Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pakistan Association of Cognitive TherapistsUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Oct 2024 (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 randomized controlled trial (RCT) will compare the efficacy and feasibility and acceptability of a culturally adapted CBT manual with a standard CBT manual, focusing on addressing cultural factors in therapy delivery.
Detailed description
Randomized Controlled Trial (RCT): Participants will be randomly assigned to either the culturally adapted CBT manual group or the standard CBT manual group. A culturally adapted manual will integrate cultural values, norms, and idioms of suffering into CBT techniques, ensuring relevance and acceptance within the target cultural group. The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations.
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 |
|---|---|---|
| culturally adapted CaCBT manual | Experimental | Behavioral: Culturally adapted CBT (CaCBT) based guided self-help manual |
| standard CBT manual | Experimental | Behavioral: Standard CBT Manual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18 to 65 years
- 5 years of education
- Symptoms of depression and anxiety
Key exclusion criteria (3 listed)
- Substance use disorder according to DSM-5 criteria as determined by primary care clinician
- Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician
- 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 |
|---|---|---|
| Culturally adapted CBT (CaCBT) based guided self-help manualThe intervention consists of seven modules including cognitive restructuring, problem solving, behavioural activation and conflict management. Three additional modules focus on interpersonal relationships, mental health wellbeing and self-care. Each module is delivered over one week. The intervention uses culturally appropriate stories, drawings, examples from local folklore and religious context to describe the concepts of CBT. | Behavioural | culturally adapted CaCBT manual |
| Standard CBT ManualThe standard CBT manual will follow conventional CBT techniques without specific cultural adaptations | Behavioural | standard CBT manual |
Primary outcome
Feasibility and acceptability measures
Time frame: 12 weeks
Feasibility and acceptability and Client's satisfaction will be measured through standardized measures of anxiety and depression
Clinical Measures
Time frame: 12 weeks
Depression and Anxiety, measured by Hosptal and Anxiety Scale (HADS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted CBT (CaCBT) based guided self-help manual and Standard CBT Manual in people with Anxiety and Depression, 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 3 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability measures (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 17 Oct 2024.