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Developing a Self-Management Program for People With Depression and Chronic Medical Illness
This study has been completed.
Study NCT00523029   Information provided by National Institute of Mental Health (NIMH)
First Received: August 28, 2007   Last Updated: March 10, 2009   History of Changes

August 28, 2007
March 10, 2009
February 2006
June 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • PRIME-MD Patient Health Questionnaire (PHQ-9) [ Time Frame: Measured at Week 8 ]
  • Qualitative interviews of participants and leaders [ Time Frame: Measured at Week 8 ]
  • Post-intervention assessments, including self-efficacy, health behaviors, health status, and service utilization [ Time Frame: Measured at Week 8 ]
Complete list of historical versions of study NCT00523029 on ClinicalTrials.gov Archive Site
 
 
 
Developing a Self-Management Program for People With Depression and Chronic Medical Illness
Self-Management of Depression and Medical Illness

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

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.

 
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Depression
Behavioral: Chronic Disease Self-Management Program
Experimental: Participants will receive a chronic disease self-management program
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
83
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00523029
Isabel Lagomasino, MD, MSHS, University of Southern California
R34 MH072631, DSIR 82-SEPC
National Institute of Mental Health (NIMH)
 
Principal Investigator: Isabel T. Lagomasino, MD, MSHS University of Southern California
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP