Effectiveness of The Step Up Wellness Program for People With Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Step Up Wellness Program for Depression, Physical Inactivity, and Smoking

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Step Up Wellness Program
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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: Self-report of bipolar disorder or schizophrenia Currently receiving specialty mental health care or smoking cessation treatment If on an antidepressant, has been taking it less than 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Control<br>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<br>* Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.<br>|
| Experimental: Step Up Intervention<br>Participants will receive the Step Up Wellness Program. The intervention is detailed below. | Behavioral: Step Up Wellness Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Smoking, Physical Activity