DepressionPhase 3StrideNCT01139060
Organized Self-Management Support Services for Chronic Depression
A Phase 3 study testing organized care program for chronic or recurrent depression in people with Depression, run by Kaiser Permanente at 2 sites in United States.
Trial summary
The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- organized care program for chronic or recurrent depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients will meet criteria for recurrent major depression or dysthymia
Who cannot join
- bipolar disorder or psychotic disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Group Health Research Insitute
Seattle, Washington, 98101
Swedish Cherry Hill Clinic
Seattle, Washington
About this study
The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.
- Conditions
- Depression
- Being tested
- organized care program for chronic or recurrent depression
- Keywords
- chronic or recurrent depression
- Medical subject headings
- Depression, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
organized care program for chronic or recurrent depressionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 18-month organized treatment program focused on outreach and engagement for chronic or recurrent depression Receives: Behavioral: organized care program for chronic or recurrent depression |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors)
Measured: 18 months
Secondary outcomes (2)
Examination of moderators of treatment response
Measured: 18 months
An estimate of the program's costs and effect on the costs of treatment for depression
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startAug 2009
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Medical Center
- Responsible party
- Sponsor
- Investigators
- Evette Ludman, PhD, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139060
- Sponsor's protocol ID
- 5R01MH082995
- Acronym
- Stride
- Status last verified
- Oct 2017
- First submitted
- 4 Jun 2010
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones SMW, Ludman EJ. Factor Structure and Sensitivity to Change of the Recovery Assessment Scale. J Behav Health Serv Res. 2018 Oct;45(4):690-699. doi: 10.1007/s11414-017-9563-x.
PubMed 28726086Ludman EJ, Simon GE, Grothaus LC, Richards JE, Whiteside U, Stewart C. Organized Self-Management Support Services for Chronic Depressive Symptoms: A Randomized Controlled Trial. Psychiatr Serv. 2016 Jan;67(1):29-36. doi: 10.1176/appi.ps.201400295. Epub 2015 Aug 17.
PubMed 26278222
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
- Organized Self-Management Support Services for Chronic Depression
- ClinicalTrials.gov ID
- NCT01139060
- Acronym / sponsor ID
- Stride / 5R01MH082995
- Conditions
- Depression
- Keywords
- chronic or recurrent depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Swedish Medical Center
- Study start
- Aug 2009
- Primary completion
- Apr 2013 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: organized care program for chronic or recurrent depression18-month organized treatment program focused on outreach and engagement for chronic or recurrent depression |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients will meet criteria for recurrent major depression or dysthymia
Key exclusion criteria (1 listed)
- bipolar disorder or psychotic disorder
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 |
|---|---|---|
| organized care program for chronic or recurrent depression | Behavioural | Intervention Group |
Primary outcome
Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors)
Time frame: 18 months
2 secondary outcomes
Examination of moderators of treatment response
Time frame: 18 months
An estimate of the program's costs and effect on the costs of treatment for depression
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Derived from this study: PubMed 28726086Jones SMW, Ludman EJ. Factor Structure and Sensitivity to Change of the Recovery Assessment Scale. J Behav Health Serv Res. 2018 Oct;45(4):690-699. doi: 10.1007/s11414-017-9563-x.
- Derived from this study: PubMed 26278222Ludman EJ, Simon GE, Grothaus LC, Richards JE, Whiteside U, Stewart C. Organized Self-Management Support Services for Chronic Depressive Symptoms: A Randomized Controlled Trial. Psychiatr Serv. 2016 Jan;67(1):29-36. doi: 10.1176/appi.ps.201400295. Epub 2015 Aug 17.
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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.
Evette Ludman, PhD principal investigator
Group Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing organized care program for chronic or recurrent depression in people with Depression, run by Kaiser Permanente at 2 sites 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 1 inclusion and 1 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 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors) (time frame: 18 months). 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 NCT01139060, which also lists 2 linked publications.
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.