Effectiveness of The Step Up Wellness Program for People With Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644995
• Other study ID #: R34MH080658
• Secondary ID: R34MH080658
• Status: Completed
• Phase: N/A
• First received: March 25, 2008
• Last updated: October 11, 2017
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Score	% with significant change (50% reduction in SCL [Symptom Checklist] depression score)	6 months
Primary	Abstinent From Smoking	self-reported 7 day point prevalent abstinence with non-responders coded as smokers	6 months
Primary	Days Walk Per Week	Mean change in days walk per week from baseline	6 months
Primary	Minutes Per Week of Moderate Physical Activity	Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)	6 months
Primary	Minutes Per Week of Vigorous Physical Activity	Mean change from baseline assessed using IPAQ physical activity scale	6 months
Secondary	Number of Cigarettes Smoked Per Day	Mean change in cigarettes smoked per day from baseline	4 months
Secondary	Quit Attempt	% who made a quit attempt, defined as intentionally not smoking for at least 24 hours	6 months