Clinical trial NCT00644995: Effectiveness of The Step Up Wellness Program for People With Depression
Official title: Step Up Wellness Program for Depression, Physical Inactivity, and Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Smoking
Physical Activity
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-03-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Depression Score
timeFrame: 6 months
measure: Abstinent From Smoking
timeFrame: 6 months
measure: Days Walk Per Week
timeFrame: 6 months
measure: Minutes Per Week of Moderate Physical Activity
timeFrame: 6 months
measure: Minutes Per Week of Vigorous Physical Activity
timeFrame: 6 months
Secondary outcomes:
measure: Number of Cigarettes Smoked Per Day
timeFrame: 4 months
measure: Quit Attempt
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Group Heatlh Research Institute
name: Jennifer McClure, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.