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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Disease Self-Management Program
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Self-management programs, Chronic medical illness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Edward R. Roybal Comprehensive Health Center
  • LAC and USC Medical Center, Outpatient Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Participants will receive a chronic disease self-management program

Outcomes

Primary Outcome Measures

PRIME-MD Patient Health Questionnaire (PHQ-9)
Qualitative interviews of participants and leaders
Post-intervention assessments, including self-efficacy, health behaviors, health status, and service utilization

Secondary Outcome Measures

Full Information

First Posted
August 28, 2007
Last Updated
December 9, 2013
Sponsor
University of Southern California
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00523029
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Self-management programs, Chronic medical illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive a chronic disease self-management program
Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Self-Management Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
PRIME-MD Patient Health Questionnaire (PHQ-9)
Time Frame
Measured at Week 8
Title
Qualitative interviews of participants and leaders
Time Frame
Measured at Week 8
Title
Post-intervention assessments, including self-efficacy, health behaviors, health status, and service utilization
Time Frame
Measured at Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel T. Lagomasino, MD, MSHS
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward R. Roybal Comprehensive Health Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
LAC and USC Medical Center, Outpatient Department
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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

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