Effectiveness of The Step Up Wellness Program for People With Depression

NCT00644995 | Completed Results

• 1 other identifier: R34MH080658
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Smoking; Physical Activity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Number of Cigarettes Smoked Per Day

  4 months

• Quit Attempt

  6 months

Study Arms (2)

Usual Care Control

ACTIVE COMPARATOR

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

Step Up Intervention

EXPERIMENTAL

Participants will receive the Step Up Wellness Program. The intervention is detailed below.

Behavioral: Step Up Wellness Program

Interventions

Step Up Wellness Program BEHAVIORAL

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.

Step Up Intervention

Usual care BEHAVIORAL

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

Usual Care Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related 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.

  PMID: 21414216 RESULT

MeSH Terms

Conditions

Depression; Smoking; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

This was a pilot feasibility trial and was not powered to detect statistically significant outcomes. Point prevalent abstinence outcomes imputed missing values as smokers.

Results Point of Contact

• Title: Jennifer McClure, PhD
• Organization: Group Health Cooperative

mcclure.j@ghc.org

206-287-2737

Study Officials

• Jennifer McClure, PhD

  Group Heatlh Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 27, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 13, 2017
• Results First Posted: July 24, 2014

Record last verified: 2017-10

Locations

US (1)