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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02593734
Other study ID # JFR
Secondary ID
Status Completed
Phase Phase 4
First received November 25, 2013
Last updated October 30, 2015
Start date July 2013
Est. completion date July 2015

Study information

Verified date October 2015
Source University of Ghana Medical School
Contact n/a
Is FDA regulated No
Health authority Ghana: Ministry of Health
Study type Interventional

Clinical 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 after the intervention.


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.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. > 18 years,<70

2. Will benefit from treatment

3. Not suffering from physical condition

4. Resident at the prayer camp

5. Not likely to be discharged from camp within six weeks

6. Speaks either English or twi

7. Able to give consent

8. Not already on medication

Exclusion Criteria:

1. likely to be discharged within 6 weeks of commencement of medication

2. Patients already on medication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Drug:
olanzapine
oral antipsychotic drug therapy
risperidone
oral antipsychotic drug therapy
amitryptaline
oral antidepressant drug therapy
fluoxetine
oral drug therapy for depression

Locations

Country Name City State
Ghana Mount Horeb Prayer Centre Mamfe

Sponsors (1)

Lead Sponsor Collaborator
University of Ghana Medical School

Country where clinical trial is conducted

Ghana, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief Psychiatric Rating Scale (BPRS) 6 weeks No
Secondary Clinical Global Impressions(CGI) 6 weeks No
Secondary Global Assessment of functioning(GAF) 6 weeks No
Secondary De-chaining, The number of days in each week that the patient was NOT restrained with physical restraints such as chains 6 weeks No
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