Effectiveness of The Step Up Wellness Program for People With Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00644995
First received: March 25, 2008
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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 Intervention
Depression
Behavioral: Step Up Wellness Program
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Step Up Wellness Program for Depression, Physical Inactivity, and Smoking

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • Depression Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    % with significant change (50% reduction in SCL [Symptom Checklist] depression score)

  • Abstinent From Smoking [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    self-reported 7 day point prevalent abstinence with non-responders coded as smokers

  • Days Walk Per Week [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean change in days walk per week from baseline

  • Minutes Per Week of Moderate Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)

  • Minutes Per Week of Vigorous Physical Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean change from baseline assessed using IPAQ physical activity scale


Secondary Outcome Measures:
  • Number of Cigarettes Smoked Per Day [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Mean change in cigarettes smoked per day from baseline

  • Quit Attempt [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    % who made a quit attempt, defined as intentionally not smoking for at least 24 hours


Enrollment: 52
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644995

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Jennifer McClure, PhD Group Heatlh Research Institute
  More Information

Publications:
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00644995     History of Changes
Other Study ID Numbers: R34 MH080658, R34MH080658
Study First Received: March 25, 2008
Results First Received: July 1, 2013
Last Updated: July 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Group Health Cooperative:
Depression
Smoking
Physical Activity

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014