From Compliance to Alliance: Engaging Psychiatric Patients in Illness Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192751
Recruitment Status : Unknown
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : September 19, 2005
Last Update Posted : October 27, 2005
Information provided by:
Rambam Health Care Campus

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.

Condition or disease Intervention/treatment Phase
Patients Diagnosed With Severe Mental Illness Behavioral: Psychoeducational group sessions Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Impact of Psycho-Educational Intervention on Patients With Severe Mental Illness Recently Discharged From Psychiatric Inpatient Services
Study Start Date : February 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders
U.S. FDA Resources

Primary Outcome Measures :
  1. Relapse prevention
  2. Illness management

Secondary Outcome Measures :
  1. Satisfaction with care

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192751

Contact: Yael Caspi, Sc.D., M.A. +972-4-854-1987

Department of Psychiatry, Rambam Medical Center Recruiting
Haifa, Israel
Principal Investigator: Yael Caspi, Sc.D., M.A.         
Sub-Investigator: Ehud Klein, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Yael Caspi, Sc.D., M.A. Department of Psychiatry, Rambam Medical Center
Study Chair: Ehud Klein, MD Department of Psychiatry, Rambam Health Center Identifier: NCT00192751     History of Changes
Other Study ID Numbers: compliance_CTIL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 27, 2005
Last Verified: September 2005

Keywords provided by Rambam Health Care Campus:
Major depression
Bipolar disorder
Relapse prevention

Additional relevant MeSH terms:
Mental Disorders