Feasibility and Acceptability Trial of a Culturally Adapted Manual Versus Standard CBT Manual: A Randomized Control Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPakistan Association of Cognitive Therapists

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals aged 18 to 65 years

5 years of education

Symptoms of depression and anxiety

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Culturally adapted CBT (CaCBT) based guided self-help manual

    Behavioral

    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 Manual

    Behavioral

    The standard CBT manual will follow conventional CBT techniques without specific cultural adaptations

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: culturally adapted CaCBT manualExperimental treatment 1 intervention
Group B: standard CBT manualExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility and acceptability measures

Feasibility and acceptability and Client's satisfaction will be measured through standardized measures of anxiety and depression

Time frame
12 weeks
2

Clinical Measures

Depression and Anxiety, measured by Hosptal and Anxiety Scale (HADS)

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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