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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

Other trials in United States

About this study

Official title: Step Up Wellness Program for Depression, Physical Inactivity, and Smoking

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 groups in NCT00644995
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.

Nov 2008Sep 2010

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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.

Detailed description

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

Results posted to the registry on 24 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	25	23
Step Up	27	23

Primary outcome: Depression Score

Time frame: 6 months. Number. Unit: percentage of participants

Measure	Usual Care n = 23	Step Up n = 24
Value	13	52

Primary outcome: Abstinent From Smoking

Time frame: 6 months. Number. Unit: percentage of participants

Measure	Usual Care n = 25	Step Up n = 27
Value	20	11

Primary outcome: Days Walk Per Week

Time frame: 6 months. Mean (Full Range). Unit: mean change in days walked per week

Measure	Usual Care n = 23	Step Up n = 23
Value	0.74 (-4.0 to 7.0)	1.13 (-5.0 to 7.0)

Primary outcome: Minutes Per Week of Moderate Physical Activity

Time frame: 6 months. Mean (Full Range). Unit: mean change in minutes per week of PA

Measure	Usual Care n = 23	Step Up n = 23
Value	96 (-360 to 1500)	121 (-600 to 2520)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 25 (0%)	0 of 25 (0%)	Not reported
Step Up	0 of 27 (0%)	0 of 27 (0%)	Not reported

Limitations and caveats (from the sponsor): This was a pilot feasibility trial and was not powered to detect statistically significant outcomes. Point prevalent abstinence outcomes imputed missing values as smokers.

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.