DepressionWtWNCT00694681
Working Toward Wellness
A study testing Telephonic care management in people with Depression, run by MDRC at 1 site in United States.
Trial summary
Working toward Wellness is a telephone care management and outreach monitoring program designed to help Medicaid recipients who are experiencing major depression to enter and remain in evidence-based treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Telephonic care management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 499 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Sep 2011
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score of 5 or higher on Quick Inventory of Depression Symptomatology
- receiving Medicaid
- at least one child in household
Who cannot join
- Bipolar disorder
- alcohol or substance abuse
- currently in active treatment for depression
- receiving Supplemental Security Income
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Services for the Hard to Employ Demonstration: Telephonic Care Management for Depressed Medicaid Recipients
Working toward Wellness is a telephone care management and outreach monitoring program designed to help Medicaid recipients who are experiencing major depression to enter and remain in evidence-based treatment. To study the effects of Working toward Wellness, individuals receiving Medicaid in Rhode Island who are eligible for mental health services through United Behavioral Health were screened by telephone for depression. Those who were found to have major depression and who agreed to be in the study were randomly assigned. Program participants received intensive monitoring from Master's level clinicians called care managers to facilitate and support clinical treatment. The control group received usual care that included only referrals to mental health treatment providers. The study hypothesis is that telephonic care management would increase visits to mental health professionals and use of appropriate medication, which in turn would reduce depression severity and lead to greater employment and productivity at work.
- Conditions
- Depression
- Being tested
- Telephonic care management
- Keywords
- Telephonic care management
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephonic care managementBehavioural
Individuals received intensive outreach from care managers, first to help them to enter treatment and then, if treatment began, to remain in it for an appropriate time. Treatment is based on the American Psychiatric Association's Evidence-Based Practice Guidelines for Major Depression, which includes psychotherapy and antidepressant medications. Outreach and care management took place by telephone.
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of mental health services
Measured: Through 36 months
Secondary outcomes (1)
Depression severity
Measured: 6, 18, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startOct 2004
- Primary completionSep 2010
- Study completionSep 2011
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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDRC
- Sponsor type
- University, hospital or other
- Collaborators
- United Behavioral Health, Kaiser Permanente, Department of Health and Human Services
- Responsible party
- Principal investigator, Charles Michalopoulos, MDRC
- Investigators
- David Butler, Principal investigator, MDRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694681
- Sponsor's protocol ID
- HHS-233-01-0012-RI
- Acronym
- WtW
- Status last verified
- Mar 2012
- First submitted
- 5 Jun 2008
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim SE, Le Blanc AJ, Michalopoulos C, Azocar F, Ludman EJ, Butler DM, Simon GE. Does telephone care management help Medicaid beneficiaries with depression? Am J Manag Care. 2011 Oct 1;17(10):e375-82.
PubMed 21999717Kim S, Leblanc A, Morris P, Simon G, Walter J. Working toward wellness: Telephone care management for Medicaid recipients with depression, thirty-six months after random assignment. New York: MDRC. December 2011.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Services for the Hard to Employ Demonstration: Telephonic Care Management for Depressed Medicaid Recipients
- ClinicalTrials.gov ID
- NCT00694681
- Acronym / sponsor ID
- WtW / HHS-233-01-0012-RI
- Conditions
- Depression
- Keywords
- Telephonic care management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- MDRCUniversity, hospital or other
- Collaborators
- United Behavioral Health, Kaiser Permanente, Department of Health and Human Services
- Study start
- Oct 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Jun 2008 (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.
Working toward Wellness is a telephone care management and outreach monitoring program designed to help Medicaid recipients who are experiencing major depression to enter and remain in evidence-based treatment. To study the effects of Working toward Wellness, individuals receiving Medicaid in Rhode Island who are eligible for mental health services through United Behavioral Health were screened by telephone for depression. Those who were found to have major depression and who agreed to be in the study were randomly assigned. Program participants received intensive monitoring from Master's level clinicians called care managers to facilitate and support clinical treatment. The control group received usual care that included only referrals to mental health treatment providers. The study hypothesis is that telephonic care management would increase visits to mental health professionals and use of appropriate medication, which in turn would reduce depression severity and lead to greater employment and productivity at work.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Score of 5 or higher on Quick Inventory of Depression Symptomatology
- receiving Medicaid
- at least one child in household
Key exclusion criteria (4 listed)
- Bipolar disorder
- alcohol or substance abuse
- currently in active treatment for depression
- receiving Supplemental Security Income
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 |
|---|---|---|
| Telephonic care managementIndividuals received intensive outreach from care managers, first to help them to enter treatment and then, if treatment began, to remain in it for an appropriate time. Treatment is based on the American Psychiatric Association's Evidence-Based Practice Guidelines for Major Depression, which includes psychotherapy and antidepressant medications. Outreach and care management took place by telephone. | Behavioural | – |
Primary outcome
Use of mental health services
Time frame: Through 36 months
1 secondary outcome
Depression severity
Time frame: 6, 18, and 36 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 27 Mar 2012.
- Results publication: PubMed 21999717Kim SE, Le Blanc AJ, Michalopoulos C, Azocar F, Ludman EJ, Butler DM, Simon GE. Does telephone care management help Medicaid beneficiaries with depression? Am J Manag Care. 2011 Oct 1;17(10):e375-82.
- Results publicationKim S, Leblanc A, Morris P, Simon G, Walter J. Working toward wellness: Telephone care management for Medicaid recipients with depression, thirty-six months after random assignment. New York: MDRC. December 2011.
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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.
David Butler principal investigator
MDRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephonic care management in people with Depression, run by MDRC 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 3 inclusion and 4 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 27 Mar 2012. 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?
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?
Use of mental health services (time frame: Through 36 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 NCT00694681, 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 27 Mar 2012.