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Clinical Trials/NCT00644995
NCT00644995
Completed
N/A

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

Kaiser Permanente1 site in 1 country52 target enrollmentNovember 2008
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Kaiser Permanente
Enrollment
52
Locations
1
Primary Endpoint
Depression Score
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
September 2010
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Number of Cigarettes Smoked Per Day(4 months)
  • Quit Attempt(6 months)

Study Sites (1)

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