Bipolar DisorderNCT05721196
Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria
A study testing Culturally adapted Psychoeducation (CaPE) and Treatment as Usual (TaU) in people with Bipolar Disorder, run by Nottingham Trent University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Culturally adapted Psychoeducation (CaPE) and Treatment as Usual (TaU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Jul 2024
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria: A Pilot Randomised Controlled Trial
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
- Being tested
- Culturally adapted Psychoeducation (CaPE), Treatment as Usual (TaU)
- 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 Psychoeducation (CaPE)Behavioural
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.
This group of patients will receive routine treatment, which in Nigeria means attending the outpatient clinic and taking prescribed medication.
| Study group | Role | What they receive |
|---|---|---|
| Culturally adapted Psychoeducation (CaPE) | Experimental | Not described Receives: Behavioral: Culturally adapted Psychoeducation (CaPE) |
| Treatment as Usual (TaU) | Active comparator | Not described Receives: Drug: Treatment as Usual (TaU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Patients' pain reduction would be assessed by the Visual Analogue Scale. For example, 0 = No pain and 10 = worst pain.
Measured: 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
Bipolar knowledge and attitude would be assessed using the Bipolar Knowledge \& attitude questionnaire
Measured: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Medication adherence
Medication adherence would be assessed using the Morisky measure of medication adherence survey
Measured: 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
Severity of mood symptoms would be assessed using the Young Mania Rating Scale (YMRS) or Beck's Depression Inventory
Measured: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Quality of life
Quality of life would be assessed using the Health-related quality of life was also measured using EuroQoL (EQ-5D)
Measured: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Teesside University, University of Manchester
- Responsible party
- Principal investigator, Dr Dung Jidong, PhD, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721196
- Sponsor's protocol ID
- 0000-0001-5034-0335e
- Status last verified
- Mar 2023
- First submitted
- 31 Jan 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05721196
- Acronym / sponsor ID
- 0000-0001-5034-0335e
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Collaborators
- University of Toronto, Teesside University, University of Manchester
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 9 Feb 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted Psychoeducation (CaPE) | Experimental | Behavioral: Culturally adapted Psychoeducation (CaPE) |
| Treatment as Usual (TaU) | Active comparator | Drug: Treatment as Usual (TaU) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 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. | Behavioural | Culturally adapted Psychoeducation (CaPE) |
| Treatment as Usual (TaU)This group of patients will receive routine treatment, which in Nigeria means attending the outpatient clinic and taking prescribed medication. | Drug | Treatment as Usual (TaU) |
Primary outcome
Pain reduction
Time frame: 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.
4 secondary outcomes
Bipolar knowledge and attitude
Time frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Medication adherence
Time frame: 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
Time frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Quality of life
Time frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted Psychoeducation (CaPE) and Treatment as Usual (TaU) in people with Bipolar Disorder, run by Nottingham Trent University.
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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Pain reduction (time frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.