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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Isabel T. Lagomasino, MD, MSHS, University of Southern California
ClinicalTrials.gov Identifier:
NCT00523029
First received: August 28, 2007
Last updated: December 9, 2013
Last verified: December 2013
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-Management of Depression and Medical Illness

Resource links provided by NLM:


Further study details as provided by University of Southern California:

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 ]

Enrollment: 104
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
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Southern California
Investigators
Principal Investigator: Isabel T. Lagomasino, MD, MSHS University of Southern California
  More Information

No publications provided

Responsible Party: Isabel T. Lagomasino, MD, MSHS, Study Principal Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT00523029     History of Changes
Other Study ID Numbers: R34 MH072631, R34MH072631, DSIR 82-SEPC
Study First Received: August 28, 2007
Last Updated: December 9, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
Self-management programs
Chronic medical illness

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014