Depression
Conditions
Keywords
Depression, Smoking, Physical Activity
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.
Interventions
BEHAVIORALStep Up Wellness Program
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.
BEHAVIORALUsual care
Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.
Sponsors
National Institute of Mental Health (NIMH)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinent From Smoking | 6 months | self-reported 7 day point prevalent abstinence with non-responders coded as smokers |
| Minutes Per Week of Moderate Physical Activity | 6 months | Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ) |
| Minutes Per Week of Vigorous Physical Activity | 6 months | Mean change from baseline assessed using IPAQ physical activity scale |
| Depression Score | 6 months | % with significant change (50% reduction in SCL \[Symptom Checklist\] depression score) |
| Days Walk Per Week | 6 months | Mean change in days walk per week from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quit Attempt | 6 months | % who made a quit attempt, defined as intentionally not smoking for at least 24 hours |
| Number of Cigarettes Smoked Per Day | 4 months | Mean change in cigarettes smoked per day from baseline |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Advice to quit smoking and referral to standard care | 25 |
| Step Up Proactive phone counseling addressing smoking, depression, and physical activity (PA) | 27 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Refused | 1 | 0 |
Baseline characteristics
| Characteristic | Step Up | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 25 Participants | 52 Participants |
| Age, Continuous | 43.5 years STANDARD_DEVIATION 11.8 | 45.4 years STANDARD_DEVIATION 11.8 | 44.5 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 27 participants | 25 participants | 52 participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 10 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
Primary
Abstinent From Smoking
self-reported 7 day point prevalent abstinence with non-responders coded as smokers
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Abstinent From Smoking | 20 percentage of participants |
| Step Up | Abstinent From Smoking | 11 percentage of participants |
Primary
Days Walk Per Week
Mean change in days walk per week from baseline
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Days Walk Per Week | 0.74 mean change in days walked per week |
| Step Up | Days Walk Per Week | 1.13 mean change in days walked per week |
Primary
Depression Score
% with significant change (50% reduction in SCL \[Symptom Checklist\] depression score)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Depression Score | 13 percentage of participants |
| Step Up | Depression Score | 52 percentage of participants |
Primary
Minutes Per Week of Moderate Physical Activity
Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Minutes Per Week of Moderate Physical Activity | 96 mean change in minutes per week of PA |
| Step Up | Minutes Per Week of Moderate Physical Activity | 121 mean change in minutes per week of PA |
Primary
Minutes Per Week of Vigorous Physical Activity
Mean change from baseline assessed using IPAQ physical activity scale
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Minutes Per Week of Vigorous Physical Activity | 60 minutes per week |
| Step Up | Minutes Per Week of Vigorous Physical Activity | 3 minutes per week |
Secondary
Number of Cigarettes Smoked Per Day
Mean change in cigarettes smoked per day from baseline
Time frame: 4 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Number of Cigarettes Smoked Per Day | -1.8 mean change in number of cigs/day smoked |
| Step Up | Number of Cigarettes Smoked Per Day | -3.2 mean change in number of cigs/day smoked |
Secondary
Quit Attempt
% who made a quit attempt, defined as intentionally not smoking for at least 24 hours
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Quit Attempt | 65 percent of participants |
| Step Up | Quit Attempt | 83 percent of participants |