Clinical trial NCT00192751: From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management
Official title: Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Diagnosed With Severe Mental Illness
Keywords: Schizophrenia
Major depression
Bipolar disorder
Compliance
Relapse prevention
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of severe mental illness, younger than 70 years of age, recently discharged from psychiatric inpatient services at the Rambam Medical Health Center.

Exclusion Criteria:

Diagnoses other than schizophrenia, major depression and bipolar disorders; 70 + years of age; organic problems

Primary outcomes:
measure: Relapse prevention
measure: Illness management
Secondary outcomes:
measure: Satisfaction with care
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Psychiatry, Rambam Medical Center
Study officials:
affiliation: Department of Psychiatry, Rambam Medical Center
name: Yael Caspi, Sc.D., M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, Rambam Health Center
name: Ehud Klein, MD
role: STUDY_CHAIR
References: