Effectiveness of The Step Up Wellness Program for People With Depression
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ClinicalTrials.gov Identifier: NCT00644995 |
Recruitment Status :
Completed
First Posted : March 27, 2008
Results First Posted : July 24, 2014
Last Update Posted : October 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.
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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.
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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

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 |
Responsible Party: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT00644995 |
Other Study ID Numbers: |
R34MH080658 ( U.S. NIH Grant/Contract ) R34MH080658 ( U.S. NIH Grant/Contract ) |
First Posted: | March 27, 2008 Key Record Dates |
Results First Posted: | July 24, 2014 |
Last Update Posted: | October 13, 2017 |
Last Verified: | October 2017 |
Depression Smoking Physical Activity |
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |