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

Depression Clinical Trial

Official title:

Self-Management of Depression and Medical Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523029
• Other study ID #: R34MH072631
• Secondary ID: R34MH072631DSIR
• Status: Completed
• Phase: N/A
• First received: August 28, 2007
• Last updated: December 9, 2013
• Start date: February 2006
• Est. completion date: June 2008

Study information

• Verified date: December 2013
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Edward R. Roybal Comprehensive Health Center	Los Angeles	California
United States	LAC and USC Medical Center, Outpatient Department	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRIME-MD Patient Health Questionnaire (PHQ-9)		Measured at Week 8	No
Primary	Qualitative interviews of participants and leaders		Measured at Week 8	No
Primary	Post-intervention assessments, including self-efficacy, health behaviors, health status, and service utilization		Measured at Week 8	No