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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00644995 |
This study will evaluate the effectiveness of a mental and physical wellness program in improving mood, physical activity, and health behaviors of people with depression who also are physically inactive and smoke cigarettes.
Condition | Intervention | Phase |
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Depression |
Behavioral: Step Up Wellness Program Behavioral: Usual care |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Step Up Wellness Program for Depression, Physical Inactivity, and Smoking |
Estimated Enrollment: | 80 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Active Comparator
Participants will receive usual care.
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Behavioral: Usual care
Participants will receive usual care for depression for 3 months.
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II: Experimental
Participants will receive the Step Up Wellness Program.
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Behavioral: Step Up Wellness Program
Participants in the 3-month Step Up Wellness program will be invited to join a walking group that will meet three times per week for about 1 hour each session. Participants will also receive weekly 30- to 45-minute phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking.
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Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. People with depression often experience a constant feeling of tiredness, which makes it difficult for them to remain physically active or to carry out other health promoting behaviors. The benefits of exercise as a treatment for mental disorders has been long recognized. Although exercise may not cure a person's depression, the physical and psychological advantages of exercise may help in relieving the symptoms of depression. It is believed that exercise provides a distraction from the negative thoughts and anxiety of depression and provides an increase in self-esteem. It is also important for people with depression to stay physically active to prevent the development of more serious illnesses, such as diabetes and heart disease. The Step Up Wellness Program, a group mental and physical wellness program, may be an effective way of helping people with depression to exercise and thus, may alleviate their depressive symptoms. This study will evaluate the effectiveness of the Step Up Wellness Program in improving mood, physical activity, and health behaviors of people with depression who also are physically inactive and smoke cigarettes.
Participation in this study will last 6 months. All participants will first complete a baseline survey that will include questions about medical history, mood, smoking, alcohol consumption, and other health-related behaviors.
Participants will then be assigned randomly to receive the Step Up Wellness Program or usual care for 3 months.
Participants in the Step Up Wellness program will be invited to join a walking group that will meet three times per week for about 1 hour each session. Participants will also receive weekly 30- to 45-minute phone calls from a study health coach. During these calls, the coach will discuss ways to improve and manage mood, increase physical activity, and prepare to quit smoking. Participants will also be given program materials that they will be asked to review between calls. Participants in the usual care group will receive standard care for depression. All participants will repeat the baseline interview at Months 3 and 6 of follow-up. Participants in the Step Up Wellness Program will additionally be asked their opinions about the program during the Month 3 interview.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
Group Health Center for Health Studies | |
Seattle, Washington, United States, 98101 |
Principal Investigator: | Jennifer McClure, PhD | Group Health Center for Health Studies |
Responsible Party: | Group Health Center for Health Studies ( Jennifer McClure, Principal Investigator ) |
Study ID Numbers: | R34 MH080658, DAHBR 96-BHB |
Study First Received: | March 25, 2008 |
Last Updated: | March 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00644995 History of Changes |
Health Authority: | United States: Federal Government |
Depression Smoking Physical Activity |
Smoking Depression Mental Disorders |
Mood Disorders Depressive Disorder Behavioral Symptoms |
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |