Group Health Research Institute
Seattle, Washington, 98101, United States
NCT Number: NCT00644995
This randomized pilot study will evaluate the feasibility and acceptability of a phone-based wellness program for improving mood, physical activity, and smoking abstinence rates among people with depression who also are physically inactive and smoke cigarettes.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98101, United States
This pilot study will evaluate the feasibility, acceptability, and potential effectiveness of the Step Up Wellness Program among people with depression who also are physically inactive and smoke cigarettes.
Participation in this study will last 6 months. All participants will complete a baseline survey and then be assigned randomly to receive the Step Up Wellness Program or usual care for 3 months. Participants in the Step Up program will receive weekly 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 materials to review and homework assignments between calls. Participants in the usual care group will receive standard care which includes referrals for treatment of depression and nicotine dependence, as well as self-help information on physical activity. All participants will be surveyed at 4 and 6 months post-enrollment. Participants will also provide qualitative feedback on the program.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the Step Up Wellness program will receive weekly 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 receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.
Time frame: 6 months
% with significant change (50% reduction in SCL [Symptom Checklist] depression score)
Time frame: 6 months
self-reported 7 day point prevalent abstinence with non-responders coded as smokers
Time frame: 6 months
Mean change in days walk per week from baseline
Time frame: 6 months
Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months
Mean change from baseline assessed using IPAQ physical activity scale
Time frame: 4 months
Mean change in cigarettes smoked per day from baseline
Time frame: 6 months
% who made a quit attempt, defined as intentionally not smoking for at least 24 hours
Kaiser Permanente
Other
Step Up Wellness Program for Depression, Physical Inactivity, and Smoking
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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