Patients Diagnosed With Severe Mental Illness Clinical Trial
Official title:
Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services
The purpose of this study is to determine the benefit and impact on relapse prevention,adherence to treatment and general health indices of participation in psycho-eduational group intervention among psychiatric patients with severe mental illness,recently discharged from inpatient services.
Medication non-compliance, estimated to affect 50% of all psychiatric patients, was shown to
be strongly associated with an elevated risk for relapse, readmission to psychiatric
inpatient care, longer length of stay and suicide, resulting in elevated costs across the
health care system. The proposed project seeks to bridge the gap between the significant
progress of recent years in psycho-pharmacology that produced more efficient ‘newer
generation’ medications, and the continuing unanswered problem of non-compliance, by
applying knowledge from clinical decision-making theories and recent evidence-based research
on the management of severe mental illness.
In Phase I of the project, an epidemiological survey will be conducted to evaluate the
magnitude and correlates of the problem in patients attending walk-in crisis clinic , using
Treatment Compliance Assessment and Decision-Making Assessment Tools, both developed by the
researchers. An 8-module psycho-educational intervention protocol emphasizing illness
management and optimization of health care decision-making will then be designed and
implemented.
In Phase II, eligible outpatient clients will be randomly assigned to either Intervention or
Standard Care conditions, and followed for a period of 15 months. Repeated assessments will
include pre-post measures of knowledge, treatment compliance, and decision-making, and on
outcome measures of relapse such as hospitalizations and symptoms, functioning,
self-efficacy, quality of life, and satisfaction with services.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training