Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana

Schizophrenia Clinical Trial

— JFR  

Official title:

Joining Forces: Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593734
• Other study ID #: JFR
• 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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Disease
• Mental Disorders
• Mood Disorders
• Mood Disorders,
• Psychotic Disorders
• Schizophrenia

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