Bipolar DisorderCaPENCT05223959
Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
A study testing Culturally adapted Psychoeducation in people with Bipolar Disorder, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Study objectives: 1. 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 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Culturally adapted Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2022to 28 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Culturally adapted Psychoeducation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted PsychoeducationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| CaPE Intervention | Experimental | 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. Receives: Behavioral: Culturally adapted Psychoeducation |
| Treatment as Usual | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Interval Follow-up Evaluation
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.
Measured: Change in scores from baseline to months 3, 6, and 12
Secondary outcomes (8)
Demographic Questionnaire
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.
Measured: Baseline
Young Mania Rating Scale
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.
Measured: Change in scores from baseline to months 3, 6, and 12
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale (HDRS-17) is a clinician-administered scale that will be used to measure severity of depression symptoms.
Measured: Change in scores from baseline to months 3, 6, and 12
Quality of life scale
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.
Measured: Change in scores from baseline to months 3, 6, and 12
Bipolar Recovery Questionnaire
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.
Measured: Change in scores from baseline to months 3, 6, and 12
Morisky Medication Adherence Scale-4 items
Morisky Medication Adherence Scale-4-item will be used to measure medication adherence.
Measured: Change in scores from baseline to months 3, 6, and 12
Bipolar Knowledge and Attitudes Questionnaire
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.
Measured: Change in scores from baseline to months 3, 6, and 12
Client Service Receipt Inventory
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.
Measured: From baseline to months 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start20 Jun 2022
- Primary completion30 Mar 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Responsible party
- Sponsor
- Investigators
- Muhammad Ishrat Husain, MD, Principal investigator, Centre for Addiction and Mental HealthNasim Chaudhry, MD, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223959
- Sponsor's protocol ID
- PILL-CaPE-002
- Acronym
- CaPE
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Husain MI, Asif M, Khoso AB, Umer M, Shakoor S, Kiran T, Tahir MR, Rajput AH, Saqib M, Husain MO, Masood S, Mufti AA, Naeem F, Bhatia MR, Siddiqui KMS, Tamizuddin A, de Oliveira C, Wang W, Xue S, Zaheer J, Husain N, Chaudhry N, Mulsant BH, Chaudhry IB. Culturally adapted psychoeducation for bipolar disorder: a multicentre, assessor-masked, randomised controlled trial. EClinicalMedicine. 2026 Oct 24;101:104271. doi: 10.1016/j.eclinm.2026.104271. eCollection 2026 Nov.
PubMed 42964307Husain MI, Umer M, Asif M, Khoso AB, Kiran T, Ansari M, Aslam H, Bhatia MR, Dogar FA, Husain MO, Khan HA, Mufti AA, Mulsant BH, Naeem F, Naqvi HA, de Oliviera C, Siddiqui MS, Tamizuddin A, Wang W, Zaheer J, Husain N, Chaudhry N, Chaudhry IB. Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial. BJPsych Open. 2022 Nov 25;8(6):e206. doi: 10.1192/bjo.2022.598.
PubMed 36426568
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Psychoeducation for Bipolar Disorder in a Low-resource Setting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05223959
- Acronym / sponsor ID
- CaPE / PILL-CaPE-002
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 4 Feb 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CaPE Intervention | Experimental | Behavioral: Culturally adapted PsychoeducationCaPE 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. |
| Treatment as Usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 PsychoeducationThis 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). | Behavioural | CaPE Intervention |
Primary outcome
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.
8 secondary outcomes
Demographic Questionnaire
Time frame: Baseline
Young Mania Rating Scale
Time frame: Change in scores from baseline to months 3, 6, and 12
Hamilton Depression Rating Scale
Time frame: 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
Bipolar Recovery Questionnaire
Time frame: Change in scores from baseline to months 3, 6, and 12
Morisky Medication Adherence Scale-4 items
Time frame: Change in scores from baseline to months 3, 6, and 12
Bipolar Knowledge and Attitudes Questionnaire
Time frame: Change in scores from baseline to months 3, 6, and 12
Client Service Receipt Inventory
Time frame: From baseline to months 3, 6, and 12
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 5 May 2026.
- Derived from this study: PubMed 42964307Husain MI, Asif M, Khoso AB, Umer M, Shakoor S, Kiran T, Tahir MR, Rajput AH, Saqib M, Husain MO, Masood S, Mufti AA, Naeem F, Bhatia MR, Siddiqui KMS, Tamizuddin A, de Oliveira C, Wang W, Xue S, Zaheer J, Husain N, Chaudhry N, Mulsant BH, Chaudhry IB. Culturally adapted psychoeducation for bipolar disorder: a multicentre, assessor-masked, randomised controlled trial. EClinicalMedicine. 2026 Oct 24;101:104271. doi: 10.1016/j.eclinm.2026.104271. eCollection 2026 Nov.
- Derived from this study: PubMed 36426568Husain MI, Umer M, Asif M, Khoso AB, Kiran T, Ansari M, Aslam H, Bhatia MR, Dogar FA, Husain MO, Khan HA, Mufti AA, Mulsant BH, Naeem F, Naqvi HA, de Oliviera C, Siddiqui MS, Tamizuddin A, Wang W, Zaheer J, Husain N, Chaudhry N, Chaudhry IB. Culturally adapted psychoeducation for bipolar disorder in a low-resource setting: protocol for a multicentre randomised controlled trial. BJPsych Open. 2022 Nov 25;8(6):e206. doi: 10.1192/bjo.2022.598.
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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.
Muhammad Ishrat Husain, MD principal investigator
Centre for Addiction and Mental Health
Nasim Chaudhry, MD principal investigator
Pakistan Institute of Living and Learning
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 Psychoeducation in people with Bipolar Disorder, run by Pakistan Institute of Living and Learning 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 6 inclusion and 4 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 5 May 2026. 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?
Longitudinal Interval Follow-up Evaluation (time frame: Change in scores from baseline to months 3, 6, and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05223959, which also lists 2 linked publications.
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 5 May 2026.