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

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ClinicalTrials.gov Identifier: NCT02593734
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
University of Ghana Medical School

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Mood Disorders, Anxiety Disorder Drug: olanzapine Drug: risperidone Drug: amitryptaline Drug: fluoxetine Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Joining Forces: Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
Study Start Date : July 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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 Name: Zyprexa

Drug: risperidone
oral antipsychotic drug therapy
Other Name: Risperdal

Drug: amitryptaline
oral antidepressant drug therapy
Other Name: Elavil

Drug: fluoxetine
oral drug therapy for depression
Other Name: Prozac




Primary Outcome Measures :
  1. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impressions(CGI) [ Time Frame: 6 weeks ]
  2. Global Assessment of functioning(GAF) [ Time Frame: 6 weeks ]
  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593734


Locations
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Ghana
Mount Horeb Prayer Centre
Mamfe, Ghana, 00233
Sponsors and Collaborators
University of Ghana Medical School
Investigators
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Principal Investigator: Angela L Ofori-Atta, PhD University of Ghana Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Ghana Medical School
ClinicalTrials.gov Identifier: NCT02593734     History of Changes
Other Study ID Numbers: JFR
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: November 2, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Disease
Schizophrenia
Anxiety Disorders
Mental Disorders
Psychotic Disorders
Mood Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Olanzapine
Risperidone
Antipsychotic Agents
Fluoxetine
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation