SchizophreniaPhase 4JFRNCT02593734
Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
A Phase 4 study testing olanzapine, risperidone and amitryptaline in people with Schizophrenia and Mood Disorders,, run by University of Ghana Medical School at 1 site in Ghana.
Trial summary
The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and daily contact with a nurse for people with mental health disorders in a prayer camp and secondly to assess whether the attitudes of the prayer camp staff toward mental health disorders and conventional medicines remain the same… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Mood Disorders,, Anxiety Disorder
- What is being tested?
- olanzapine, risperidone and amitryptaline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteGhana
- Study dates
- Jul 2013to Jul 2015
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years,<70
- Will benefit from treatment
- Not suffering from physical condition
- Resident at the prayer camp
- Not likely to be discharged from camp within six weeks
- Speaks either English or twi
- Able to give consent
- Not already on medication
Who cannot join
- likely to be discharged within 6 weeks of commencement of medication
- Patients already on medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Joining Forces: Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and daily contact with a nurse for people with mental health disorders in a prayer camp and secondly to assess whether the attitudes of the prayer camp staff toward mental health disorders and conventional medicines remain the same after the intervention.
Read the detailed description
The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and daily contact with a nurse for people with mental health disorders in a prayer camp and secondly to assess whether the attitudes of the prayer camp staff toward mental health disorders and conventional medicines remain the same after the intervention.
In the proposed study, residents of the sanatorium at the Mount Horeb Prayer Center located in Mamfe, Ghana will be screened for psychiatric disorders by a psychiatrist. Those who are diagnosed with a psychiatric disorder requiring treatment (schizophrenia, or mood disorder) and who meet the other inclusion criteria (see below) will be randomly assigned to receive a daily dose of the appropriate psychotropic drug (according to standard procedures of care) as well as regular prayer camp treatment (intervention group) or to receive only regular prayer camp treatment (control group). After randomization, the patients in the intervention group will receive the bundled treatment for 6 weeks, while control group patients will receive regular prayer camp treatment, e.g. encouragement to pray. Psychiatrists blinded to group assignments will assess outcomes over a 6 - 8 week period. Following this, patients will be referred for continued care with health care facilities as close to their homes as possible on discharge and if they so desire. At the start of the intervention, pastors and attendants at the prayer camp will be qualitatively assessed through a semi-structured interview concerning their attributions of mental illness causation. They will be assessed -0, -6 weeks after and again -12 weeks after intervention. The investigators hypothesize that patients who receive the bundled intervention will have improved mental health outcomes and functioning and that prayer camp staff will develop more positive attitudes toward conventional medicine and will begin to conceptualize mental health disorders as treatable illnesses, rather than only as a spiritual disorder. The results will provide empirical evidence for or against an integrated model of community based care which encompasses the medical and spiritual. This is the first intervention study in Sub-Saharan Africa to promote the use of psychotropic drugs in a traditional or spiritual healing setting. Its findings may inform the implementation of national policies governing collaboration between primary health care and faith healing centers, expanding access to and improving the quality of mental health care services.
- Conditions
- Schizophrenia, Mood Disorders,, Anxiety Disorder
- Being tested
- olanzapine, risperidone, amitryptaline, fluoxetine
- Medical subject headings
- Schizophrenia, Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called Zyprexa
oral antipsychotic drug therapy
risperidoneDrug
Also called Risperdal
oral antipsychotic drug therapy
amitryptalineDrug
Also called Elavil
oral antidepressant drug therapy
fluoxetineDrug
Also called Prozac
oral drug therapy for depression
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Experimental | Experimental | The intervention is prescription and dispensing by a nurse of oral antipsychotic or antidepressant medication as clinically indicated. The mediations to be selected from include oral olanzapine, risperidone, amitryptaline or fluoxetine at doses prescribed by the treating psychiatrist. Receives: Drug: olanzapine; Drug: risperidone; Drug: amitryptaline; Drug: fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale (BPRS)
Measured: 6 weeks
Secondary outcomes (3)
Clinical Global Impressions(CGI)
Measured: 6 weeks
Global Assessment of functioning(GAF)
Measured: 6 weeks
De-chaining,
The number of days in each week that the patient was NOT restrained with physical restraints such as chains
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ghana Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela L Ofori-Atta, PhD, Principal investigator, University of Ghana Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593734
- Sponsor's protocol ID
- JFR
- Acronym
- JFR
- Status last verified
- Oct 2015
- First submitted
- 25 Nov 2013
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ofori-Atta A, Attafuah J, Jack H, Baning F, Rosenheck R; Joining Forces Research Consortium. Joining psychiatric care and faith healing in a prayer camp in Ghana: randomised trial. Br J Psychiatry. 2018 Jan;212(1):34-41. doi: 10.1192/bjp.2017.12.
PubMed 29433613
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joining Forces: Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
- ClinicalTrials.gov ID
- NCT02593734
- Acronym / sponsor ID
- JFR / JFR
- Conditions
- Schizophrenia, Mood Disorders,, Anxiety Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of Ghana Medical SchoolUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Nov 2015 (estimated)
- 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.
The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and daily contact with a nurse for people with mental health disorders in a prayer camp and secondly to assess whether the attitudes of the prayer camp staff toward mental health disorders and conventional medicines remain the same after the intervention.
Detailed description
The purpose of this study is to evaluate a bundled intervention of psychotropic drugs and daily contact with a nurse for people with mental health disorders in a prayer camp and secondly to assess whether the attitudes of the prayer camp staff toward mental health disorders and conventional medicines remain the same after the intervention.
In the proposed study, residents of the sanatorium at the Mount Horeb Prayer Center located in Mamfe, Ghana will be screened for psychiatric disorders by a psychiatrist. Those who are diagnosed with a psychiatric disorder requiring treatment (schizophrenia, or mood disorder) and who meet the other inclusion criteria (see below) will be randomly assigned to receive a daily dose of the appropriate psychotropic drug (according to standard procedures of care) as well as regular prayer camp treatment (intervention group) or to receive only regular prayer camp treatment (control group). After randomization, the patients in the intervention group will receive the bundled treatment for 6 weeks, while control group patients will receive regular prayer camp treatment, e.g. encouragement to pray. Psychiatrists blinded to group assignments will assess outcomes over a 6 - 8 week period. Following this, patients will be referred for continued care with health care facilities as close to their homes as possible on discharge and if they so desire. At the start of the intervention, pastors and attendants at the prayer camp will be qualitatively assessed through a semi-structured interview concerning their attributions of mental illness causation. They will be assessed -0, -6 weeks after and again -12 weeks after intervention. The investigators hypothesize that patients who receive the bundled intervention will have improved mental health outcomes and functioning and that prayer camp staff will develop more positive attitudes toward conventional medicine and will begin to conceptualize mental health disorders as treatable illnesses, rather than only as a spiritual disorder. The results will provide empirical evidence for or against an integrated model of community based care which encompasses the medical and spiritual. This is the first intervention study in Sub-Saharan Africa to promote the use of psychotropic drugs in a traditional or spiritual healing setting. Its findings may inform the implementation of national policies governing collaboration between primary health care and faith healing centers, expanding access to and improving the quality of mental health care services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Experimental | Experimental | Drug: olanzapine, Drug: risperidone, Drug: amitryptaline, Drug: fluoxetineThe intervention is prescription and dispensing by a nurse of oral antipsychotic or antidepressant medication as clinically indicated. The mediations to be selected from include oral olanzapine, risperidone, amitryptaline or fluoxetine at doses prescribed by the treating psychiatrist. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- > 18 years,<70
- Will benefit from treatment
- Not suffering from physical condition
- Resident at the prayer camp
- Not likely to be discharged from camp within six weeks
Key exclusion criteria (2 listed)
- likely to be discharged within 6 weeks of commencement of medication
- Patients already on medication
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 |
|---|---|---|
| olanzapineAlso: Zyprexaoral antipsychotic drug therapy | Drug | Experimental |
| risperidoneAlso: Risperdaloral antipsychotic drug therapy | Drug | Experimental |
| amitryptalineAlso: Elaviloral antidepressant drug therapy | Drug | Experimental |
| fluoxetineAlso: Prozacoral drug therapy for depression | Drug | Experimental |
Primary outcome
Brief Psychiatric Rating Scale (BPRS)
Time frame: 6 weeks
3 secondary outcomes
Clinical Global Impressions(CGI)
Time frame: 6 weeks
Global Assessment of functioning(GAF)
Time frame: 6 weeks
De-chaining,
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Derived from this study: PubMed 29433613Ofori-Atta A, Attafuah J, Jack H, Baning F, Rosenheck R; Joining Forces Research Consortium. Joining psychiatric care and faith healing in a prayer camp in Ghana: randomised trial. Br J Psychiatry. 2018 Jan;212(1):34-41. doi: 10.1192/bjp.2017.12.
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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.
Angela L Ofori-Atta, PhD principal investigator
University of Ghana Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olanzapine, risperidone and amitryptaline in people with Schizophrenia and Mood Disorders,, run by University of Ghana Medical School at 1 site in Ghana.
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief Psychiatric Rating Scale (BPRS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02593734, which also lists 1 linked publication.
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 2 Nov 2015.