We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of The Step Up Wellness Program for People With Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00644995
Recruitment Status : Completed
First Posted : March 27, 2008
Results First Posted : July 24, 2014
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kaiser Permanente

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Step Up Wellness Program Behavioral: Usual care Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Jennifer McClure, PhD Group Heatlh Research Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
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
Keywords provided by Kaiser Permanente:
Depression
Smoking
Physical Activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders