A Randomised Controlled Feasibility Trial of Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria
Study Details
Study Description
Brief Summary
Bipolar Disorders (BDs) are chronic mental health disorders that often result in functional impairment which constitutes a significant disease burden (Husain et al. 2017). It also accounts for 7% of the disability-adjusted life years (DALY) caused by mental disorders (Whiteford et al. 2013). Four out of 10 persons with a probable diagnosis of BDs received no mental health care within the preceding 12 months (Humpston et al. 2021). Compared to the general population, individuals with BDs tend to have a significantly higher rate of associated suicide mortality (Crump et al., 2013). Within the last decade, these mortality rates have substantially increased (Lomholt et al. 2019), suggesting the need for targeted research to address the unresolved needs of individuals suffering from BDs. A recent meta-analysis found that compared to the general population, bipolar patients had reduced life expectancy with about 13 years of potential life loss (Chan et al. 2022).
BDs are historically under-researched compared to other mental health disorders, especially in Sub-Saharan Africa and Nigeria (Jidong et al., 2023). Our recent study on "Bipolar disorders in Nigeria" (Jidong et al., 2023) provided insight into contextual knowledge and beliefs about BDs, including the lived experiences of patients with BDs, their caregivers, and clinicians in Nigeria. The study recommended culturally adapted psychosocial intervention for bipolar patients, and hence the proposed study titled "A randomised controlled feasibility trial of Culturally adapted Psychoeducation (CaPE) for bipolar disorders in Nigeria".
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Culturally adapted Psychoeducation (CaPE)
|
Behavioral: Culturally adapted Psychoeducation (CaPE)
This intervention consisted of 12 psychoeducation sessions, one session per week, that would be administered on an individual patient basis and to be added to treatment as usual. Each session lasted for approximately 1 h, beginning with a 20-30 min 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 relapse). The content is a reduced and modified version of the Barcelona Psychoeducation Program for bipolar disorders.
|
| Active Comparator: Treatment as Usual (TaU)
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Drug: Treatment as Usual (TaU)
This group of patients will receive routine treatment, which in Nigeria means attending the outpatient clinic and taking prescribed medication.
|
Outcome Measures
Primary Outcome Measures
- Change in patient satisfaction [Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
Primary outcome measure would be assessed using the Visual Analogue Scale (VAS)
Secondary Outcome Measures
- Change in bipolar knowledge and attitude [Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
Secondary outcome measure would be assessed using the Bipolar Knowledge & attitude questionnaire (BKAQ)
- Change in medication adherence [Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
Secondary outcome measure would be assessed using the Morisky measure of medication adherence survey (MMAS-4)
- Change in the severity of mood symptoms [Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
Secondary outcome measure would be assessed using the Young Mania Rating Scale (YMRS) or Beck's Depression Inventory (BDI)
- Change in quality of life [Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention]
Secondary outcome measure would be assessed using the Health-related quality of life was also measured using EuroQoL (EQ-5D)
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of DSM IV bipolar affective disorder
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currently euthymic (BDI < 12 and YMRS < 8)
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age 18-65 years, participants engaged with the mental health services for the preceding 6 months
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able to give written informed consent
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resident of the trial catchment area and
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the ability to speak English.
Exclusion Criteria:
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severe cognitive impairment
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currently experiencing relapse (mania, hypomania, mixed or depressive)
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being actively suicidal
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the presence of any comorbid psychiatric illness such as substance misuse or alcohol dependence according to DSM IV criteria.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nottingham Trent University
- University of Toronto
- Teesside University
- University of Manchester
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0000-0001-5034-0335e