- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05223959
Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial (CaPE)
September 22, 2022 updated by: Pakistan Institute of Living and Learning
Study objectives:
- To determine the effectiveness of the CaPE intervention compared to treatment as usual (TAU) in reducing the time to recurrence for people with bipolar disorder (BD) I/II, currently in remission in Pakistan
- To determine the impact of the CaPE intervention compared to TAU on clinical outcomes, quality of life and functioning; and
- To estimate the cost-effectiveness of CaPE in a low-resource setting (i.e., Pakistan) (if the RCT confirms the effectiveness of CaPE in BD.
Study design and setting:
This will be a multi-centre, assessor blind, individual, parallel-arm randomized controlled trial (RCT) with Pakistani patients with BD.
Sample Size:
The study aims to recruit a total of N=300 participants in total.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Psychoeducation (PE) is an effective adjunctive treatment option in BD, however, despite the clear benefits, there are only limited, underpowered studies of PE from LMICs, including Pakistan.
Therefore, the current study aims to test the effectiveness of Culturally adapted PsychoEducation (CaPE) intervention for people with BD in Pakistan.
The study will include a total of N=300 people with BD from psychiatric units of teaching and non-teaching hospitals in 8 centres across Pakistan including Karachi, Lahore, Multan, Rawalpindi, Peshawar, Hyderabad, Shaheed Benazirabad and Quetta.
Consented participants meeting eligibility criteria will be randomised in a 1:1 allocation to CaPE or TAU.
Randomization will be computer generated and use a random permuted block method with variable block sizes stratified by site, bipolar type (I or II) and self-reported sex.
Participants in CaPE intervention group will receive 12-weekly one-to-one psychoeducation sessions.
Each CaPE session will last for approximately 1 hour, beginning with a 20-30-minute presentation on the topic of the day, followed by a related exercise (e.g., drawing a life chart or compiling a list of potential triggers for recurrence).
Sessions will be delivered by trained psychologists who will receive regular weekly supervision to maintain fidelity.
The other group will receive TAU/control group.
Assessments will be carried out at baseline, months 3, 6, and 12 either in-person and/or via secure videoconference software (alternatives to in-person for COVID-19 or travel restrictions) by trained, blinded research analysts (RAs).
The treatment groups will be compared with each other at baseline and then at subsequent follow-ups at 3, 6 and 12 months.
We will also conduct in-depth, one-to-one interviews with service users from the intervention arm (15-20), carers (15-20) and all therapists involved in the trial.
A cost-utility analysis from a healthcare system and societal perspective will be conducted to establish the cost-effectiveness of CaPE against TAU.
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MUQADDAS ASIF
- Phone Number: 042-35842310
- Email: muqaddas.asif@pill.org.pk
Study Contact Backup
- Name: Madeha Umer
- Email: Madeha.Umer@camh.ca
Study Locations
-
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Select An Option…
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Lahore, Select An Option…, Pakistan, 55000
- Recruiting
- Lahore general hospital
-
Contact:
- MUQADDAS ASIF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult outpatients age 18 and above
- Diagnosis of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) bipolar disorder (both BD I and BD II), currently in remission, confirmed by Structured Clinical Interview for DSM-5 (SCID)
- Currently euthymic (Hamilton Depression Rating Scale, HDRS-17 < 8 and Young Mania Rating Scale, YMRS <8)
- Able to give written informed consent
- On stable psychiatric medication regimen for at least 3 months
- Resident of the trial catchment area.
Exclusion Criteria:
- Active substance use disorder, based on DSM-5 criteria
- Currently experiencing recurrence (mania, hypomania, mixed or depressive
- Active suicidal ideation
- Unstable residential arrangements that reduce likelihood of being available for the duration of trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CaPE Intervention
CaPE is a manualized intervention consisting of 12 one-to-one psychoeducation sessions, one session per week.
Each session will last for 60 minutes.
All sessions will be delivered by a trained therapist who will receive two months training from senior therapists before starting intervention.
|
This is a culturally adapted psychoeducation program consisting of 12 sessions.
Each CaPE session lasts for approximately 60 minutes, beginning with a 20-30-minute presentation on the topic of the day, followed by a related exercise (e.g., drawing a life chart or compiling a list of potential triggers for recurrence).
|
No Intervention: Treatment as Usual
Treatment as usual (TAU) will be ascertained by the participant's treating physician.
Research staff will record the nature and intensity of TAU delivered to each participant over a period of 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longitudinal Interval Follow-up Evaluation
Time Frame: Change in scores from baseline to months 3, 6, and 12
|
Longitudinal Interval Follow-up Evaluation (LIFE) is an integrated system for assessing the longitudinal course of psychiatric disorders.
The assessment will consist of a semi-structured interview, during which an interviewer uses the LIFE to collect detailed psychosocial, psychopathologic, and treatment information for the follow-up interval.
The weekly psychopathology measures are ordinal symptom-based scales with categories defined to match the criteria of the DSM-5.
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Change in scores from baseline to months 3, 6, and 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic Questionnaire
Time Frame: Baseline
|
Demographic Questionnaire will be used to assess baseline demographics including age, gender, self-reported sex, marital status, smoking status, employment status, education and monthly income.
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Baseline
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Young Mania Rating Scale
Time Frame: Change in scores from baseline to months 3, 6, and 12
|
Young Mania Rating Scale (YMRS) will be used to assess manic symptom severity.
The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours.
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Change in scores from baseline to months 3, 6, and 12
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Hamilton Depression Rating Scale
Time Frame: Change in scores from baseline to months 3, 6, and 12
|
Hamilton Depression Rating Scale (HDRS-17) is a clinician-administered scale that will be used to measure severity of depression symptoms.
|
Change in scores from baseline to months 3, 6, and 12
|
Quality of life scale
Time Frame: Change in scores from baseline to months 3, 6, and 12
|
EuroQol-5D (EQ- 5D) EQ-5D will be used to assess health-related quality of life over 5 dimensions (mobility, self-care, daily activities, pain-discomfort, anxiety and depression) 44.
It also includes and a Visual Analogue Scale that evaluates patients' perceived health status.
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Change in scores from baseline to months 3, 6, and 12
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Bipolar Recovery Questionnaire
Time Frame: Change in scores from baseline to months 3, 6, and 12
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Bipolar Recovery Questionnaire (BRQ) is a 36-item questionnaire that will be used to measure functioning and personal experiences of recovery specific to patients with BD.
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Change in scores from baseline to months 3, 6, and 12
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Morisky Medication Adherence Scale-4 items
Time Frame: Change in scores from baseline to months 3, 6, and 12
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Morisky Medication Adherence Scale-4-item will be used to measure medication adherence.
|
Change in scores from baseline to months 3, 6, and 12
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Bipolar Knowledge and Attitudes Questionnaire
Time Frame: Change in scores from baseline to months 3, 6, and 12
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Bipolar Knowledge and Attitudes Questionnaire (BKAQ) is a 25-item questionnaire developed for use in primary care to assess knowledge and attitudes towards bipolar disorder.
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Change in scores from baseline to months 3, 6, and 12
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Client Service Receipt Inventory
Time Frame: From baseline to months 3, 6, and 12
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Client Service Receipt Inventory (CSRI) is a tool used to collect information on the whole range of services and supports study participants may be accessing.
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From baseline to months 3, 6, and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nasim Chaudhry, MD, Pakistan Institute of Living and Learning
- Principal Investigator: Muhammad Ishrat Husain, MD, Centre for Addiction and Mental Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2022
Primary Completion (Anticipated)
March 1, 2026
Study Completion (Anticipated)
June 1, 2026
Study Registration Dates
First Submitted
January 25, 2022
First Submitted That Met QC Criteria
January 25, 2022
First Posted (Actual)
February 4, 2022
Study Record Updates
Last Update Posted (Actual)
September 26, 2022
Last Update Submitted That Met QC Criteria
September 22, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PILL-CaPE-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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