Effectiveness of The Step Up Wellness Program for People With Depression
|ClinicalTrials.gov Identifier: NCT00644995|
Recruitment Status : Completed
First Posted : March 27, 2008
Results First Posted : July 24, 2014
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Step Up Wellness Program Behavioral: Usual care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Step Up Wellness Program for Depression, Physical Inactivity, and Smoking|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||September 2010|
Active Comparator: Usual Care Control
Participants will receive usual care which includes advice to stop smoking and referral to standard care treatment available through participants' health insurance and health plan.
Behavioral: Usual care
Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.
Experimental: Step Up Intervention
Participants will receive the Step Up Wellness Program. The intervention is detailed below.
Behavioral: Step Up Wellness Program
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.
- Depression Score [ Time Frame: 6 months ]% with significant change (50% reduction in SCL [Symptom Checklist] depression score)
- Abstinent From Smoking [ Time Frame: 6 months ]self-reported 7 day point prevalent abstinence with non-responders coded as smokers
- Days Walk Per Week [ Time Frame: 6 months ]Mean change in days walk per week from baseline
- Minutes Per Week of Moderate Physical Activity [ Time Frame: 6 months ]Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)
- Minutes Per Week of Vigorous Physical Activity [ Time Frame: 6 months ]Mean change from baseline assessed using IPAQ physical activity scale
- Number of Cigarettes Smoked Per Day [ Time Frame: 4 months ]Mean change in cigarettes smoked per day from baseline
- Quit Attempt [ Time Frame: 6 months ]% who made a quit attempt, defined as intentionally not smoking for at least 24 hours
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644995
|United States, Washington|
|Group Health Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Jennifer McClure, PhD||Group Heatlh Research Institute|