Trial Outcomes & Findings for Effectiveness of The Step Up Wellness Program for People With Depression (NCT NCT00644995)

NCT ID: NCT00644995

Last Updated: 2017-10-13

Results Overview

% with significant change (50% reduction in SCL \[Symptom Checklist\] depression score)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-10-13

Participant Flow

Participants were recruited from Group Health, a large regional health plan.Potential participants were identified from automated medical records, mailed study invitation letters, and then contacted by phone to be screened for interest and eligibility.

Participant milestones

Measure	Usual Care Advice to quit and referral to standard care	Step Up proactive phone counseling addressing smoking, depression, and PA
Overall Study STARTED	25	27
Overall Study Completed 4 Month Assessment	23	24
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Usual Care Advice to quit and referral to standard care	Step Up proactive phone counseling addressing smoking, depression, and PA
Overall Study Lost to Follow-up	1	4
Overall Study Refused	1	0

Baseline Characteristics

Effectiveness of The Step Up Wellness Program for People With Depression

Baseline characteristics by cohort

Measure	Usual Care n=25 Participants Advice to quit smoking and referral to standard care	Step Up n=27 Participants Proactive phone counseling addressing smoking, depression, and physical activity (PA)	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.4 years STANDARD_DEVIATION 11.8 • n=5 Participants	43.5 years STANDARD_DEVIATION 11.8 • n=7 Participants	44.5 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	27 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

% with significant change (50% reduction in SCL [Symptom Checklist] depression score)

Outcome measures

Measure	Usual Care n=23 Participants Advice to quit and referral to standard care	Step Up n=24 Participants Proactive phone counseling addressing smoking, depression and physical activity
Depression Score	13 percentage of participants Interval 1.85 to	52 percentage of participants

PRIMARY outcome

Timeframe: 6 months

self-reported 7 day point prevalent abstinence with non-responders coded as smokers

Outcome measures

Measure	Usual Care n=25 Participants Advice to quit and referral to standard care	Step Up n=27 Participants Proactive phone counseling addressing smoking, depression and physical activity
Abstinent From Smoking	20 percentage of participants	11 percentage of participants

PRIMARY outcome

Timeframe: 6 months

Mean change in days walk per week from baseline

Outcome measures

Measure	Usual Care n=23 Participants Advice to quit and referral to standard care	Step Up n=23 Participants Proactive phone counseling addressing smoking, depression and physical activity
Days Walk Per Week	0.74 mean change in days walked per week Interval -4.0 to 7.0	1.13 mean change in days walked per week Interval -5.0 to 7.0

PRIMARY outcome

Timeframe: 6 months

Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)

Outcome measures

Measure	Usual Care n=23 Participants Advice to quit and referral to standard care	Step Up n=23 Participants Proactive phone counseling addressing smoking, depression and physical activity
Minutes Per Week of Moderate Physical Activity	96 mean change in minutes per week of PA Interval -360.0 to 1500.0	121 mean change in minutes per week of PA Interval -600.0 to 2520.0

PRIMARY outcome

Timeframe: 6 months

Mean change from baseline assessed using IPAQ physical activity scale

Outcome measures

Measure	Usual Care n=23 Participants Advice to quit and referral to standard care	Step Up n=23 Participants Proactive phone counseling addressing smoking, depression and physical activity
Minutes Per Week of Vigorous Physical Activity	60 minutes per week Interval -45.0 to 360.0	3 minutes per week Interval -960.0 to 480.0

SECONDARY outcome

Timeframe: 4 months

Mean change in cigarettes smoked per day from baseline

Outcome measures

Measure	Usual Care n=25 Participants Advice to quit and referral to standard care	Step Up n=27 Participants Proactive phone counseling addressing smoking, depression and physical activity
Number of Cigarettes Smoked Per Day	-1.8 mean change in number of cigs/day smoked Interval -14.0 to 10.0	-3.2 mean change in number of cigs/day smoked Interval -20.0 to 5.0

SECONDARY outcome

Timeframe: 6 months

% who made a quit attempt, defined as intentionally not smoking for at least 24 hours

Outcome measures

Measure	Usual Care n=23 Participants Advice to quit and referral to standard care	Step Up n=23 Participants Proactive phone counseling addressing smoking, depression and physical activity
Quit Attempt	65 percent of participants	83 percent of participants

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Step Up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer McClure, PhD

Group Health Cooperative

Phone: 206-287-2737

Email: mcclure.j@ghc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place