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Completed

NCT Number: NCT02593734

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mount Horeb Prayer Centre

Mamfe, 00233, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

oral antipsychotic drug therapy

Other names: Zyprexa

Risperidone

Drug

oral antipsychotic drug therapy

Other names: Risperdal

amitryptaline

Drug

oral antidepressant drug therapy

Other names: Elavil

Fluoxetine

Drug

oral drug therapy for depression

Other names: Prozac

Primary outcomes

  1. Brief Psychiatric Rating Scale (BPRS)

    Time frame: 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ghana Medical School

Other

Registry information

Official study title

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

Acronym: JFR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2015
Registry last updated
Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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