Bipolar Disorder
Conditions
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.
Interventions
BEHAVIORALCulturally 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.
DRUGTreatment as Usual (TaU)
This group of patients will receive routine treatment, which in Nigeria means attending the outpatient clinic and taking prescribed medication.
Sponsors
University of Toronto
Teesside University
University of Manchester
Nottingham Trent University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction | Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention | Patients' pain reduction would be assessed by the Visual Analogue Scale. For example, 0 = No pain and 10 = worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Bipolar knowledge and attitude would be assessed using the Bipolar Knowledge & attitude questionnaire |
| Medication adherence | Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention | Medication adherence would be assessed using the Morisky measure of medication adherence survey |
| 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 | Severity of mood symptoms would be assessed using the Young Mania Rating Scale (YMRS) or Beck's Depression Inventory |
| Quality of life | Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention | Quality of life would be assessed using the Health-related quality of life was also measured using EuroQoL (EQ-5D) |
Outcome results
None listed