Ignite Creation Date:
2024-05-06 @ 7:45 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02593734
Status:
COMPLETED
Last Update Posted:
2015-11-01
First Post:
2013-11-25
Brief Title:
Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
Sponsor:
University of Ghana Medical School
Organization:
University of Ghana Medical School
Study Overview
Official Title:
Joining Forces Integrating Psychotropic Medication Into the Care of People With Mental Disorders in a Prayer Camp in Ghana
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JFR
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None