Effectiveness of The Step Up Wellness Program for People With Depression

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Member of Group Health insurance plan
Aged 18 to 75
Experiencing at least moderate depressive symptoms
Low physical activity defined as failure to meet Centers for Disease Control (CDC) guidelines for weekly activity OR low to moderate physical activity as assessed by International Physical Activity Questionnaire (IPAQ)
Current smoker
Has a phone
Able to read and speak in English
No mobility or physical impairments that would prevent engaging in moderate physical activity
Without a hearing impairment that would prevent participation with the phone-based counseling or assessments

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Usual Care Control	Usual care	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.
Step Up Intervention	Step Up Wellness Program	Participants will receive the Step Up Wellness Program. The intervention is detailed below.

Primary Outcome Measures

Name	Time	Method
Days Walk Per Week	6 months	Mean change in days walk per week from baseline
Depression Score	6 months	% with significant change (50% reduction in SCL \[Symptom Checklist\] depression score)
Abstinent From Smoking	6 months	self-reported 7 day point prevalent abstinence with non-responders coded as smokers
Minutes Per Week of Moderate Physical Activity	6 months	Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)
Minutes Per Week of Vigorous Physical Activity	6 months	Mean change from baseline assessed using IPAQ physical activity scale

Secondary Outcome Measures

Name	Time	Method
Number of Cigarettes Smoked Per Day	4 months	Mean change in cigarettes smoked per day from baseline
Quit Attempt	6 months	% who made a quit attempt, defined as intentionally not smoking for at least 24 hours