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Completed

NCT Number: NCT00644995

Effectiveness of The Step Up Wellness Program for People With Depression

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group Health Research Institute

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step Up Wellness Program

Behavioral

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.

Usual Care

Behavioral

Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.

Primary outcomes

  1. Depression Score

    Time frame: 6 months

    % with significant change (50% reduction in SCL [Symptom Checklist] depression score)

  2. Abstinent From Smoking

    Time frame: 6 months

    self-reported 7 day point prevalent abstinence with non-responders coded as smokers

  3. Days Walk Per Week

    Time frame: 6 months

    Mean change in days walk per week from baseline

  4. Minutes Per Week of Moderate Physical Activity

    Time frame: 6 months

    Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)

  5. Minutes Per Week of Vigorous Physical Activity

    Time frame: 6 months

    Mean change from baseline assessed using IPAQ physical activity scale

Secondary outcomes

  1. Number of Cigarettes Smoked Per Day

    Time frame: 4 months

    Mean change in cigarettes smoked per day from baseline

  2. Quit Attempt

    Time frame: 6 months

    % who made a quit attempt, defined as intentionally not smoking for at least 24 hours

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 27, 2008
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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