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

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Developing a Self-Management Program for People With Depression and Chronic Medical Illness
Official Title  Self-Management of Depression and Medical Illness
Brief Summary

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

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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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 ]
Secondary Outcome Measure 
Condition  Depression
Intervention  Behavioral: Chronic Disease Self-Management Program
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  48
Start Date  February 2006
Completion Date June 2008
Eligibility 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
Gender Both
Ages 18 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Jennifer Green, MSW     323-442-4044     jennifmg@usc.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00523029
Organization ID R34 MH72631
Secondary IDs †† DSIR 82-SEPC
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Isabel T. Lagomasino, MD, MSHS     University of Southern California    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date March 2008
First Received Date  August 28, 2007
Last Updated Date March 6, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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