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Effectiveness of The Step Up Wellness Program for People With Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Step Up Wellness Program
Usual care
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Smoking, Physical Activity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Group Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care Control

Step Up Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2008
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00644995
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Smoking, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Step Up Intervention
Arm Type
Experimental
Arm Description
Participants will receive the Step Up Wellness Program. The intervention is detailed below.
Intervention Type
Behavioral
Intervention Name(s)
Step Up Wellness Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.
Primary Outcome Measure Information:
Title
Depression Score
Description
% with significant change (50% reduction in SCL [Symptom Checklist] depression score)
Time Frame
6 months
Title
Abstinent From Smoking
Description
self-reported 7 day point prevalent abstinence with non-responders coded as smokers
Time Frame
6 months
Title
Days Walk Per Week
Description
Mean change in days walk per week from baseline
Time Frame
6 months
Title
Minutes Per Week of Moderate Physical Activity
Description
Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)
Time Frame
6 months
Title
Minutes Per Week of Vigorous Physical Activity
Description
Mean change from baseline assessed using IPAQ physical activity scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Cigarettes Smoked Per Day
Description
Mean change in cigarettes smoked per day from baseline
Time Frame
4 months
Title
Quit Attempt
Description
% who made a quit attempt, defined as intentionally not smoking for at least 24 hours
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer McClure, PhD
Organizational Affiliation
Group Heatlh Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21414216
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.
Results Reference
result

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Effectiveness of The Step Up Wellness Program for People With Depression

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