Developing a Self-Management Program for People With Depression and Chronic Medical Illness - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00523029

Purpose

This study seeks to adapt an existing chronic disease self-management program for people with both chronic medical illness and depression.

Condition	Intervention
Depression	Behavioral: Chronic Disease Self-Management Program

MedlinePlus related topics: Coping with Chronic Illness Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Self-Management of Depression and Medical Illness

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

PRIME-MD Patient Health Questionnaire (PHQ-9) [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Qualitative interviews of participants and leaders [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Post-intervention assessments, including self-efficacy, health behaviors, health status, and service utilization [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	February 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive a chronic disease self-management program	Behavioral: Chronic Disease Self-Management Program Chronic disease self-management is a 6-week group program that teaches participants how to manage their chronic medical illness. Group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions.

Arms

Assigned Interventions

1: Experimental

Participants will receive a chronic disease self-management program

Behavioral: Chronic Disease Self-Management Program

Chronic disease self-management is a 6-week group program that teaches participants how to manage their chronic medical illness. Group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions.

Detailed Description:

Depression is a common but serious disorder that affects millions of people every year. Depression can severely impact people's lives, causing them to often feel sad and hopeless as well as affecting their sleep patterns, concentration, and energy levels. Treatment typically includes a combination of antidepressant medication and talk therapy. This study will evaluate the effectiveness of an adapted group education program typically used for chronic medical illness in improving the health status, health behaviors, and use of health care services among people with depression and a chronic illness.

Participants in this open-label study will attend a group education program used to manage chronic medical illness. Group sessions will be held for 2.5 hours, once a week, for 6 weeks. Group leaders, also suffering from a chronic medical condition, will lead discussions based on the following topics: nutrition; exercise; appropriate use of medications; ways to communicate effectively with family, friends, and health care professionals; and how to make informed treatment decisions. Participants will also complete two surveys: one at the beginning of the study and one at the end. The first survey will ask basic questions related to participants' health status and any feelings of stress, anxiety, or sadness. The second survey will include a brief interview that will require participants to describe their experience in the group sessions and to suggest ways of improving the program to better accommodate people with depression and chronic illness. Responses to questions will be used to enhance the effectiveness of the group education program for treating people with both depression and a chronic medical condition.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria for Patients:

Currently attending the Edward R. Roybal Comprehensive Health Center or the LAC+USC Outpatient Department for primary care
English- or Spanish-speaking
Screens positive for major depressive disorder or minor depression based on the PRIME MD PHQ-9
Suffers from a chronic medical illness (e.g., lung disease, asthma, emphysema or trouble breathing; heart disease or heart problems; high blood sugar or diabetes; arthritis or rheumatism)

Inclusion Criteria for Group Leaders:

Prior experience facilitating a chronic disease self-management program within 6 to 9 months of study entry (including the groups held at Roybal Comprehensive Health Center)

Exclusion Criteria for Patients:

Acutely suicidal
Screens positive for bipolar disorder, psychotic disorder, or cognitive impairment disorder
History of alcohol or drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523029

Locations

United States, California
Edward R. Roybal Comprehensive Health Center
Los Angeles, California, United States, 90022
LAC and USC Medical Center, Outpatient Department
Los Angeles, California, United States, 90033

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Isabel T. Lagomasino, MD, MSHS

University of Southern California

More Information

Responsible Party:	University of Southern California ( Isabel Lagomasino, MD, MSHS )
Study ID Numbers:	R34 MH72631, DSIR 82-SEPC
Study First Received:	August 28, 2007
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00523029
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Self-management programs
Chronic medical illness

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009