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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH080658 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Step Up Intervention | Experimental | Participants will receive the Step Up Wellness Program. The intervention is detailed below. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Smoked Per Day | Mean change in cigarettes smoked per day from baseline | 4 months |
| Quit Attempt | % who made a quit attempt, defined as intentionally not smoking for at least 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer McClure, PhD | Group Heatlh Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21414216 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Advice to quit and referral to standard care |
| FG001 | Step Up | proactive phone counseling addressing smoking, depression, and PA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Advice to quit smoking and referral to standard care |
| BG001 | Step Up | Proactive phone counseling addressing smoking, depression, and physical activity (PA) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression Score | % with significant change (50% reduction in SCL [Symptom Checklist] depression score) | Posted | Number | percentage of participants | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Advice to quit and referral to standard care |
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This was a pilot feasibility trial and was not powered to detect statistically significant outcomes.
Point prevalent abstinence outcomes imputed missing values as smokers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer McClure, PhD | Group Health Cooperative | 206-287-2737 | mcclure.j@ghc.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D012907 | Smoking |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Usual care | Behavioral | Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention. |
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| 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Abstinent From Smoking | self-reported 7 day point prevalent abstinence with non-responders coded as smokers | Posted | Number | percentage of participants | 6 months |
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| Primary | Days Walk Per Week | Mean change in days walk per week from baseline | Posted | Mean | Full Range | mean change in days walked per week | 6 months |
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| Primary | Minutes Per Week of Moderate Physical Activity | Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ) | Posted | Mean | Full Range | mean change in minutes per week of PA | 6 months |
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| Primary | Minutes Per Week of Vigorous Physical Activity | Mean change from baseline assessed using IPAQ physical activity scale | Posted | Mean | Full Range | minutes per week | 6 months |
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| Secondary | Number of Cigarettes Smoked Per Day | Mean change in cigarettes smoked per day from baseline | Posted | Mean | Full Range | mean change in number of cigs/day smoked | 4 months |
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| Secondary | Quit Attempt | % who made a quit attempt, defined as intentionally not smoking for at least 24 hours | Posted | Number | percent of participants | 6 months |
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Step Up | Proactive phone counseling addressing smoking, depression, and physical activity | 0 | 27 | 0 | 27 |
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