Effectiveness of The Step Up Wellness Program for People With Depression

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Usual care; Behavioral: Step Up Wellness Program

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Group Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression Score	% with significant change (50% reduction in SCL [Symptom Checklist] depression score)	6 months
Abstinent From Smoking	self-reported 7 day point prevalent abstinence with non-responders coded as smokers	6 months
Days Walk Per Week	Mean change in days walk per week from baseline	6 months
Minutes Per Week of Moderate Physical Activity	Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)	6 months
Minutes Per Week of Vigorous Physical Activity	Mean change from baseline assessed using IPAQ physical activity scale	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Cigarettes Smoked Per Day	Mean change in cigarettes smoked per day from baseline	4 months
Quit Attempt	% who made a quit attempt, defined as intentionally not smoking for at least 24 hours	6 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jennifer McClure, PhD, Group Heatlh Research Institute

Publications and helpful links

General Publications

• McClure JB, Catz SL, Ludman EJ, Richards J, Riggs K, Grothaus L. Feasibility and acceptability of a multiple risk factor intervention: the Step Up randomized pilot trial. BMC Public Health. 2011 Mar 17;11:167. doi: 10.1186/1471-2458-11-167.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 25, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Physical Activity; Smoking
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: R34MH080658 (U.S. NIH Grant/Contract)