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From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management

Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00192751
Enrollment
150
Registered
2005-09-19
Start date
2004-02-29
Completion date
2006-12-31
Last updated
2005-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Diagnosed With Severe Mental Illness

Keywords

Schizophrenia, Major depression, Bipolar disorder, Compliance, Relapse prevention

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.

Interventions

BEHAVIORALPsychoeducational group sessions

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Relapse prevention
Illness management

Secondary

MeasureTime frame
Satisfaction with care

Countries

Israel

Contacts

Primary ContactYael Caspi, Sc.D., M.A.
y_caspi@rambam.health.gov.il+972-4-854-1987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026