Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria

Bipolar Disorder Clinical Trial

Official title:

Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria: A Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05721196
• Other study ID #: 0000-0001-5034-0335e
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2023
• Source: Nottingham Trent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bipolar disorders are chronic mental health disorders that often result in functional impairment, constituting a significant disease burden. It also accounts for seven per cent of disability-adjusted life years caused by mental disorders. Four out of ten persons with a probable diagnosis of bipolar disorders received no mental health care within the preceding twelve months. Compared to the general population, individuals with bipolar disorders tend to have a significantly higher rate of associated suicide mortality. Within the last decade, these mortality rates have substantially increased, suggesting the need for targeted research to address the unresolved needs of individuals suffering from bipolar disorders. A recent meta-analysis found that compared to the general population, bipolar patients had reduced life expectancy with about thirteen years of potential life loss.

Bipolar disorders are historically under-researched compared to other mental health disorders, especially in Sub-Saharan Africa and Nigeria. Our recent study on bipolar disorders in Nigeria provided insight into contextual knowledge and beliefs about bipolar disorders, including the lived experiences of patients with bipolar disorders, their caregivers, and clinicians in Nigeria. The study recommended culturally adapted psychosocial intervention for bipolar patients, hence the proposed research.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• diagnosis of DSM IV bipolar affective disorder

• currently euthymic (BDI < 12 and YMRS < 8)

• age 18-65 years, participants engaged with the mental health services for the preceding 6 months

• able to give written informed consent

• resident of the trial catchment area and

• the ability to speak English.

Exclusion Criteria:

• severe cognitive impairment

• currently experiencing relapse (mania, hypomania, mixed or depressive)

• being actively suicidal

• the presence of any comorbid psychiatric illness such as substance misuse or alcohol dependence according to DSM IV criteria.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Nottingham Trent University	Teesside University, University of Manchester, University of Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Patients' pain reduction would be assessed by the Visual Analogue Scale. For example, 0 = No pain and 10 = worst pain.	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Secondary	Bipolar knowledge and attitude	Bipolar knowledge and attitude would be assessed using the Bipolar Knowledge & attitude questionnaire	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Secondary	Medication adherence	Medication adherence would be assessed using the Morisky measure of medication adherence survey	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Secondary	Severity of mood symptoms	Severity of mood symptoms would be assessed using the Young Mania Rating Scale (YMRS) or Beck's Depression Inventory	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Secondary	Quality of life	Quality of life would be assessed using the Health-related quality of life was also measured using EuroQoL (EQ-5D)	Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention