SchizophreniaNCT00400166
Recovery Guide Intervention for Recurrent Psychiatric Hospitalization
A study testing Recovery Mentor in people with Schizophrenia and Schizoaffective Disorder, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Recovery Guide support services are effective in promoting recovery and social integration among psychiatrically disabled individuals who experience high rates of inpatient hospitalizations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- Recovery Mentor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to May 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Currently admitted in the Yale-New Haven Psychiatric Hospital (YNHPH)
- A history of two or more prior admissions within the past 18 months
- Proficient in the use of the English language
- A DSM-IV diagnosis of Schizophrenia, Schizoaffective Disorder, Psychotic Disorder NOS, or Major Depressive Disorder with Psychotic Features
Who cannot join
- Inability to give signed, written consent
- Primary DSM-IV diagnosis of substance abuse/dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Psychiatric Hospital
New Haven, Connecticut, 06519
About this study
The purpose of this study is to determine whether Recovery Guide support services are effective in promoting recovery and social integration among psychiatrically disabled individuals who experience high rates of inpatient hospitalizations.
Read the detailed description
The paradigm shift in mental health treatment from a deficit-and institution- based framework to a recovery and community integration frame necessitates new models of "case management" practices. The Recovery Guide model is just such a model. Beyond theoretical frameworks, the effectiveness of Recovery Guides has not been well studied. It is the intent of this study to conduct a randomized trial examining the effects of Recovery Guides on community tenure and integration. Furthermore, it is the intent of this study to to establish fidelity criteria.
Comparison(s): Recovery Guide services in addition to treatment as usual, compared to treatment as usual.
- Being tested
- Recovery Mentor
- Keywords
- Peer support, Psychiatric disability, Mutual support, Psychiatric Rehabilitation
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery MentorBehavioural
Provided Recovery Mentor services
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Recovery Mentor: peer-based supportive care Receives: Behavioral: Recovery Mentor |
| 0 | No intervention | No Recovery Mentor, services as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalizations
Measured: 9 months
Secondary outcomes (7)
Sense of community
Measured: Baseline, 3 and 9 months
Motivation for change
Measured: Baseline, 3 and 9 months
Social functioning
Measured: Baseline, 3 abd 9 months
Hope
Measured: Baseline, 3 and 9 months
Self-determination
Measured: Baseline, 3 and 9 months
Functional status
Measured: Baseline, 3 and 9 months
Treatment relationship
Measured: Baseline, 3 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Connecticut State, Department of Mental Health and Addiction Services, Eli Lilly and Company
- Investigators
- William H Sledge, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400166
- Sponsor's protocol ID
- 0607001641
- Status last verified
- Jun 2009
- First submitted
- 15 Nov 2006
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Connell MJ, Sledge WH, Staeheli M, Sells D, Costa M, Wieland M, Davidson L. Outcomes of a Peer Mentor Intervention for Persons With Recurrent Psychiatric Hospitalization. Psychiatr Serv. 2018 Jul 1;69(7):760-767. doi: 10.1176/appi.ps.201600478. Epub 2018 Apr 16.
PubMed 29656708
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Guide Intervention for Recurrent Psychiatric Hospitalization
- ClinicalTrials.gov ID
- NCT00400166
- Acronym / sponsor ID
- 0607001641
- Keywords
- Peer support, Psychiatric disability, Mutual support, Psychiatric Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Connecticut State, Department of Mental Health and Addiction Services, Eli Lilly and Company
- Study start
- Dec 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Nov 2006 (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 of this study is to determine whether Recovery Guide support services are effective in promoting recovery and social integration among psychiatrically disabled individuals who experience high rates of inpatient hospitalizations.
Detailed description
The paradigm shift in mental health treatment from a deficit-and institution- based framework to a recovery and community integration frame necessitates new models of "case management" practices. The Recovery Guide model is just such a model. Beyond theoretical frameworks, the effectiveness of Recovery Guides has not been well studied. It is the intent of this study to conduct a randomized trial examining the effects of Recovery Guides on community tenure and integration. Furthermore, it is the intent of this study to to establish fidelity criteria.
Comparison(s): Recovery Guide services in addition to treatment as usual, compared to treatment as usual.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Recovery MentorRecovery Mentor: peer-based supportive care |
| 0 | No intervention | –No Recovery Mentor, services as usual |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Currently admitted in the Yale-New Haven Psychiatric Hospital (YNHPH)
- A history of two or more prior admissions within the past 18 months
- Proficient in the use of the English language
- A DSM-IV diagnosis of Schizophrenia, Schizoaffective Disorder, Psychotic Disorder NOS, or Major Depressive Disorder with Psychotic Features
Key exclusion criteria (2 listed)
- Inability to give signed, written consent
- Primary DSM-IV diagnosis of substance abuse/dependence
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 |
|---|---|---|
| Recovery MentorProvided Recovery Mentor services | Behavioural | 1 |
Primary outcome
Number of hospitalizations
Time frame: 9 months
7 secondary outcomes
Sense of community
Time frame: Baseline, 3 and 9 months
Motivation for change
Time frame: Baseline, 3 and 9 months
Social functioning
Time frame: Baseline, 3 abd 9 months
Hope
Time frame: Baseline, 3 and 9 months
Self-determination
Time frame: Baseline, 3 and 9 months
Functional status
Time frame: Baseline, 3 and 9 months
Treatment relationship
Time frame: Baseline, 3 and 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 12 Jun 2009.
- Derived from this study: PubMed 29656708O'Connell MJ, Sledge WH, Staeheli M, Sells D, Costa M, Wieland M, Davidson L. Outcomes of a Peer Mentor Intervention for Persons With Recurrent Psychiatric Hospitalization. Psychiatr Serv. 2018 Jul 1;69(7):760-767. doi: 10.1176/appi.ps.201600478. Epub 2018 Apr 16.
- Yale Program for Recovery and Community HealthLink provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
William H Sledge, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Mentor in people with Schizophrenia and Schizoaffective Disorder, 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 5 inclusion and 2 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 12 Jun 2009. 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?
Number of hospitalizations (time frame: 9 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 NCT00400166, 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 12 Jun 2009.