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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. |
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| 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. |
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| 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 ] |
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| 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:
Inclusion Criteria for Group Leaders:
Exclusion Criteria for Patients:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| 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 † |
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| 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 | ||||