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

Primary Purpose

Schizophrenia, Mood Disorders,, Anxiety Disorder

Status
Completed
Phase
Phase 4
Locations
Ghana
Study Type
Interventional
Intervention
olanzapine
risperidone
amitryptaline
fluoxetine
Sponsored by
University of Ghana Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Horeb Prayer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Experimental

Arm Description

No intervention

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.

Outcomes

Primary Outcome Measures

Brief Psychiatric Rating Scale (BPRS)

Secondary Outcome Measures

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

Full Information

First Posted
November 25, 2013
Last Updated
October 30, 2015
Sponsor
University of Ghana Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02593734
Brief Title
Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
Acronym
JFR
Official Title
Joining Forces: Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ghana Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Mood Disorders,, Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
olanzapine
Other Intervention Name(s)
Zyprexa
Intervention Description
oral antipsychotic drug therapy
Intervention Type
Drug
Intervention Name(s)
risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
oral antipsychotic drug therapy
Intervention Type
Drug
Intervention Name(s)
amitryptaline
Other Intervention Name(s)
Elavil
Intervention Description
oral antidepressant drug therapy
Intervention Type
Drug
Intervention Name(s)
fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
oral drug therapy for depression
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions(CGI)
Time Frame
6 weeks
Title
Global Assessment of functioning(GAF)
Time Frame
6 weeks
Title
De-chaining,
Description
The number of days in each week that the patient was NOT restrained with physical restraints such as chains
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 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 Exclusion Criteria: likely to be discharged within 6 weeks of commencement of medication Patients already on medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela L Ofori-Atta, PhD
Organizational Affiliation
University of Ghana Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Horeb Prayer Centre
City
Mamfe
ZIP/Postal Code
00233
Country
Ghana

12. IPD Sharing Statement

Citations:
PubMed Identifier
29433613
Citation
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.
Results Reference
derived

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

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