From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management

NCT ID: NCT00192751

Last Updated: 2005-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-12-31

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.

Conditions

Patients Diagnosed With Severe Mental Illness

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: ECT
• Blinding Strategy: NONE

Interventions

Psychoeducational group sessions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Principal Investigators

Yael Caspi, Sc.D., M.A.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Rambam Medical Center

Ehud Klein, MD

Role: STUDY_CHAIR

Department of Psychiatry, Rambam Health Center

Locations

Department of Psychiatry, Rambam Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yael Caspi, Sc.D., M.A.

Role: CONTACT

Phone: +972-4-854-1987

Email: y_caspi@rambam.health.gov.il

Other Identifiers

compliance_CTIL

Identifier Type: -

Identifier Source: org_study_id