Clinical trial NCT00523029: Developing a Self-Management Program for People With Depression and Chronic Medical Illness
Official title: Self-Management of Depression and Medical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Self-management programs
Chronic medical illness
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-08-30
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PRIME-MD Patient Health Questionnaire (PHQ-9)
timeFrame: Measured at Week 8
measure: Qualitative interviews of participants and leaders
timeFrame: Measured at Week 8
measure: Post-intervention assessments, including self-efficacy, health behaviors, health status, and service utilization
timeFrame: Measured at Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Edward R. Roybal Comprehensive Health Center
state: California
city: Los Angeles
country: United States
facility: LAC and USC Medical Center, Outpatient Department
state: California
Study officials:
affiliation: University of Southern California
name: Isabel T. Lagomasino, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References: