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

October 30, 2015 updated by: University of Ghana Medical School

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Mamfe, Ghana, 00233
        • Mount Horeb Prayer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.
Drug: olanzapine
oral antipsychotic drug therapy
Other Names:
  • Zyprexa
Drug: risperidone
oral antipsychotic drug therapy
Other Names:
  • Risperdal
Drug: amitryptaline
oral antidepressant drug therapy
Other Names:
  • Elavil
Drug: fluoxetine
oral drug therapy for depression
Other Names:
  • Prozac

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Psychiatric Rating Scale (BPRS)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impressions(CGI)
Time Frame: 6 weeks
6 weeks
Global Assessment of functioning(GAF)
Time Frame: 6 weeks
6 weeks
De-chaining,
Time Frame: 6 weeks
The number of days in each week that the patient was NOT restrained with physical restraints such as chains
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ghana Medical School

Investigators

  • Principal Investigator: Angela L Ofori-Atta, PhD, University of Ghana Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

October 30, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JFR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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