DepressionNCT00644995
Effectiveness of The Step Up Wellness Program for People With Depression
A study testing Step Up Wellness Program in people with Depression, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- Step Up Wellness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Step Up Wellness Program for Depression, Physical Inactivity, and Smoking
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Step Up Wellness Program, Usual care
- Keywords
- Depression, Smoking, Physical Activity
- Medical subject headings
- Depression, Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step Up Wellness ProgramBehavioural
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.
Usual careBehavioural
Participants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Usual care |
| Step Up Intervention | Experimental | Participants will receive the Step Up Wellness Program. The intervention is detailed below. Receives: Behavioral: Step Up Wellness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Score
% with significant change (50% reduction in SCL [Symptom Checklist] depression score)
Measured: 6 months
Abstinent From Smoking
self-reported 7 day point prevalent abstinence with non-responders coded as smokers
Measured: 6 months
Days Walk Per Week
Mean change in days walk per week from baseline
Measured: 6 months
Minutes Per Week of Moderate Physical Activity
Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)
Measured: 6 months
Minutes Per Week of Vigorous Physical Activity
Mean change from baseline assessed using IPAQ physical activity scale
Measured: 6 months
Secondary outcomes (2)
Number of Cigarettes Smoked Per Day
Mean change in cigarettes smoked per day from baseline
Measured: 4 months
Quit Attempt
% who made a quit attempt, defined as intentionally not smoking for at least 24 hours
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jennifer McClure, PhD, Principal investigator, Group Heatlh Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644995
- Sponsor's protocol ID
- R34MH080658
- Other IDs
- R34MH080658
- Status last verified
- Oct 2017
- First submitted
- 25 Mar 2008
- Last updated
- 13 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21414216
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Up Wellness Program for Depression, Physical Inactivity, and Smoking
- ClinicalTrials.gov ID
- NCT00644995
- Acronym / sponsor ID
- R34MH080658
- Conditions
- Depression
- Keywords
- Depression, Smoking, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Posted 24 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Control | Active comparator | Behavioral: Usual careParticipants will receive usual care which includes advice to stop smoking and referral to standard care treatment available through participants' health insurance and health plan. |
| Step Up Intervention | Experimental | Behavioral: Step Up Wellness ProgramParticipants will receive the Step Up Wellness Program. The intervention is detailed below. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step Up Wellness ProgramParticipants 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. | Behavioural | Step Up Intervention |
| Usual careParticipants will receive referral usual care treatment for depression and smoking cessation, plus self-help physical activity intervention. | Behavioural | Usual Care Control |
Primary outcome
Depression Score
Time frame: 6 months
% with significant change (50% reduction in SCL [Symptom Checklist] depression score)
Abstinent From Smoking
Time frame: 6 months
self-reported 7 day point prevalent abstinence with non-responders coded as smokers
Days Walk Per Week
Time frame: 6 months
Mean change in days walk per week from baseline
Minutes Per Week of Moderate Physical Activity
Time frame: 6 months
Mean change from baseline as assessed using International Physical Activity Questionnaire (IPAQ)
Minutes Per Week of Vigorous Physical Activity
Time frame: 6 months
Mean change from baseline assessed using IPAQ physical activity scale
2 secondary outcomes
Number of Cigarettes Smoked Per Day
Time frame: 4 months
Quit Attempt
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21414216McClure 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer McClure, PhD principal investigator
Group Heatlh Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step Up Wellness Program in people with Depression, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Score (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00644995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.