Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria

NCT05721196 | Unknown

• 1 other identifier: 0000-0001-5034-0335e
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Medication adherence

  Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

• 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

• Quality of life

  Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Study Arms (2)

Culturally adapted Psychoeducation (CaPE)

EXPERIMENTAL

Behavioral: Culturally adapted Psychoeducation (CaPE)

Treatment as Usual (TaU)

ACTIVE COMPARATOR

Drug: Treatment as Usual (TaU)

Interventions

Culturally adapted Psychoeducation (CaPE) BEHAVIORAL

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.

Culturally adapted Psychoeducation (CaPE)

Treatment as Usual (TaU) DRUG

This group of patients will receive routine treatment, which in Nigeria means attending the outpatient clinic and taking prescribed medication.

Treatment as Usual (TaU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham Trent University: lead
• University of Toronto: collaborator
• Teesside University: collaborator
• University of Manchester: collaborator

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: August 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share