Serious Mental IllnessProject PEPNCT01566513
Effectiveness and Cost Effectiveness of Peer Mentors in Reducing Hospital Use
A study testing Community Connector, Peer Recovery Mentor and Peer Case Manager in people with Serious Mental Illness, run by Yale University at 1 site in United States.
Trial summary
The current study, through a randomized controlled design, will evaluate the effectiveness of peer support, as compared to usual care and to an equivalent amount of support offered by peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions and in promoting recovery and community… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serious Mental Illness
- What is being tested?
- Community Connector, Peer Recovery Mentor and Peer Case Manager
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Nov 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2 or more psychiatric hospitalizations in the past year
- A diagnosis of serious mental illness
Who cannot join
- Dementia or other organic condition limiting ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Psychiatric Hospital
New Haven, Connecticut, 06519
About this study
The current study, through a randomized controlled design, will evaluate the effectiveness of peer support, as compared to usual care and to an equivalent amount of support offered by peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions and in promoting recovery and community inclusion among adults with mental illnesses with histories of multiple hospitalizations. The current study evaluates the cost-effectiveness of adding peer support to the array of services available to persons with serious mental illnesses who have histories of multiple hospitalizations and will test a theoretical model of the active ingredients of peer support, focusing specifically on the roles of 1) instillation of hope through positive self-disclosure; 2) role modeling of self-care and exploring new ways of using experiential knowledge; and 3) a trusting relationship characterized by acceptance, understanding, and empathy with conditional regard.
- Conditions
- Serious Mental Illness
- Being tested
- Community Connector, Peer Recovery Mentor, Peer Case Manager
- Keywords
- Peer Support, Cost Effectiveness, Reducing Hospital use, Serious Mental Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community ConnectorBehavioural
The participant randomized into this arm of the study is invited to work with a person trained as a community connector, someone who is trained in Intentional Peer Support but does not have a lived experience of mental illness.
Peer Recovery MentorBehavioural
A participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support.
Peer Case ManagerBehavioural
A participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Not described |
| Community Connector | Experimental | The participant randomized into this arm of the study is invited to work with a person trained as a community connector, who is trained in Intentional Peer Support but does not have a lived experience of mental illness. Receives: Behavioral: Community Connector |
| Peer Recovery Mentor | Experimental | A participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support. Receives: Behavioral: Peer Recovery Mentor |
| Peer Case Manager | Experimental | If a participant is randomized into this condition, they are offered the chance to work with a Case Manager, who is trained in strengths-based case management. Receives: Behavioral: Peer Case Manager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service use
Via self-report from the participant
Measured: 3 months
Service Use
Via self-report from the participant
Measured: 9 months
Secondary outcomes (6)
Psychiatric symptoms
Measured using the Symptom Distress scale and the Paranoia and Psychoticism subscales from the Symptom Check List-90 (SCL-90)
Measured: 3 months
Quality of life
Measured using Lehman's Brief Quality of Life scale
Measured: 3 month
Community inclusion
Measured using Mancini's Community Connections Inventory
Measured: 3 months
Psychiatric symptoms
Measured using the Symptom Distress scale and the Paranoia and Psychoticism subscales from the Symptom Check List-90 (SCL-90)
Measured: 9 months
Quality of Life
Measured using Lehman's Brief Quality of Life scale
Measured: 9 months
Community Inclusion
Measured using Mancini's Community Connections Inventory
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Larry Davidson, PhD, Principal investigator, Yale Program for Recovery and Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566513
- Sponsor's protocol ID
- 1010007542
- Other IDs
- 1R01MH091453
- Acronym
- Project PEP
- Status last verified
- Jan 2015
- First submitted
- 26 Mar 2012
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost Effectiveness of Peer Mentors in Reducing Hospital Use
- ClinicalTrials.gov ID
- NCT01566513
- Acronym / sponsor ID
- Project PEP / 1010007542
- Conditions
- Serious Mental Illness
- Keywords
- Peer Support, Cost Effectiveness, Reducing Hospital use, Serious Mental Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Mar 2012 (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 current study, through a randomized controlled design, will evaluate the effectiveness of peer support, as compared to usual care and to an equivalent amount of support offered by peer case managers and non-peer recovery mentors, in reducing hospital days and readmissions and in promoting recovery and community inclusion among adults with mental illnesses with histories of multiple hospitalizations. The current study evaluates the cost-effectiveness of adding peer support to the array of services available to persons with serious mental illnesses who have histories of multiple hospitalizations and will test a theoretical model of the active ingredients of peer support, focusing specifically on the roles of 1) instillation of hope through positive self-disclosure; 2) role modeling of self-care and exploring new ways of using experiential knowledge; and 3) a trusting relationship characterized by acceptance, understanding, and empathy with conditional regard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | – |
| Community Connector | Experimental | Behavioral: Community ConnectorThe participant randomized into this arm of the study is invited to work with a person trained as a community connector, who is trained in Intentional Peer Support but does not have a lived experience of mental illness. |
| Peer Recovery Mentor | Experimental | Behavioral: Peer Recovery MentorA participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support. |
| Peer Case Manager | Experimental | Behavioral: Peer Case ManagerIf a participant is randomized into this condition, they are offered the chance to work with a Case Manager, who is trained in strengths-based case management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 2 or more psychiatric hospitalizations in the past year
- A diagnosis of serious mental illness
Key exclusion criteria (1 listed)
- Dementia or other organic condition limiting ability to provide informed consent
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 |
|---|---|---|
| Community ConnectorThe participant randomized into this arm of the study is invited to work with a person trained as a community connector, someone who is trained in Intentional Peer Support but does not have a lived experience of mental illness. | Behavioural | Community Connector |
| Peer Recovery MentorA participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support. | Behavioural | Peer Recovery Mentor |
| Peer Case ManagerA participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support. | Behavioural | Peer Case Manager |
Primary outcome
Service use
Time frame: 3 months
Via self-report from the participant
Service Use
Time frame: 9 months
Via self-report from the participant
6 secondary outcomes
Psychiatric symptoms
Time frame: 3 months
Quality of life
Time frame: 3 month
Community inclusion
Time frame: 3 months
Psychiatric symptoms
Time frame: 9 months
Quality of Life
Time frame: 9 months
Community Inclusion
Time frame: 9 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 26 Jan 2015.
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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.
Larry Davidson, PhD principal investigator
Yale Program for Recovery and Community Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Connector, Peer Recovery Mentor and Peer Case Manager in people with Serious Mental Illness, run by Yale University 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 2 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 26 Jan 2015. 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?
Service use (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2015.