Dual DiagnosisPhase 1NCT01329393
Benefits Management for People With Psychiatric Disabilities
A Phase 1 study testing Benefits Management and Illness Management and Recovery in people with Dual Diagnosis and Schizophrenia, run by Yale University at 1 site in United States.
Trial summary
This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Diagnosis, Schizophrenia, Bipolar Disorder
- What is being tested?
- Benefits Management and Illness Management and Recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Dec 2013
- Phase
- Phase 1
- 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
- Has received treatment for a psychiatric disorder within 60 days of enrollment
- Receives SSI or SSDI payments totaling at least $600 per month
- Has an identified outpatient clinician
- Either i) Homeless within the past 3 months. Homeless is defined as having spent at least seven days in a shelter, outdoors (e.g. in a park, in a car), in a public or abandoned building (e.g. train station), or temporarily (less than a continuous month) housed by family or friends OR ii) Hospitalized within the past 3 months
- Justification for Inclusion Criteria: Homelessness and hospitalization are common reasons for payee assignment (Conrad, Matters et al. 1998). In a prior study, we found that a high proportion of hospitalized inpatients meet criteria for needing a payee (Rosen, Rosenheck et al. 2002a). There is no point enrolling clinically stable outpatients in this study because they are unlikely to need payees.
Who cannot join
- Already has a conservator or representative payee
- An application to assign a payee or conservator has been initiated
- Unable to speak and understand English
Trial locations and contacts
1 site in 1 country.
About this study
This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses.
- Conditions
- Dual Diagnosis, Schizophrenia, Bipolar Disorder
- Being tested
- Benefits Management, Illness Management and Recovery
- Keywords
- Disability, Social Security, Representative Payee
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benefits ManagementBehavioural
Money-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee.
Illness Management and RecoveryBehavioural
Recovery Oriented Training in Biopsychosocial Model of Stress and How to Cope with Stress
| Study group | Role | What they receive |
|---|---|---|
| Benefits Management | Experimental | Money-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee. Receives: Behavioral: Benefits Management |
| Illness Management and Recovery | Active comparator | Not described Receives: Behavioral: Illness Management and Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Summed score on the Heinrich-Carpenter Quality of Life Measure
The Heinrich-Carpenter Quality of Life score is derived by summing ratings of individual items after a semi-structured interview. The possible score on any given interview is 0-126. It is a global measure of social functioning with higher scores indicating better functioning.
Measured: Change from Week 0 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startAug 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dual DiagnosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), VA Connecticut Healthcare System
- Responsible party
- Sponsor
- Investigators
- Marc I. Rosen, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329393
- Sponsor's protocol ID
- 0910005874
- Other IDs
- R34MH083894
- Status last verified
- Jul 2014
- First submitted
- 2 Feb 2011
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits Management for People With Psychiatric Disabilities
- ClinicalTrials.gov ID
- NCT01329393
- Acronym / sponsor ID
- 0910005874
- Conditions
- Dual Diagnosis, Schizophrenia, Bipolar Disorder
- Keywords
- Disability, Social Security, Representative Payee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), VA Connecticut Healthcare System
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Apr 2011 (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.
This stage 1 clinical trial will determine pilot efficacy, develop a therapy manual, and collect qualitative data concerning a brief money management intervention for people disabled by psychiatric illnesses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benefits Management | Experimental | Behavioral: Benefits ManagementMoney-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee. |
| Illness Management and Recovery | Active comparator | Behavioral: Illness Management and Recovery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has received treatment for a psychiatric disorder within 60 days of enrollment
- Receives SSI or SSDI payments totaling at least $600 per month
- Has an identified outpatient clinician
- Either i) Homeless within the past 3 months. Homeless is defined as having spent at least seven days in a shelter, outdoors (e.g. in a park, in a car), in a public or abandoned building (e.g. train station), or temporarily (less than a continuous month) housed by family or friends OR ii) Hospitalized within the past 3 months
- Justification for Inclusion Criteria: Homelessness and hospitalization are common reasons for payee assignment (Conrad, Matters et al. 1998). In a prior study, we found that a high proportion of hospitalized inpatients meet criteria for needing a payee (Rosen, Rosenheck et al. 2002a). There is no point enrolling clinically stable outpatients in this study because they are unlikely to need payees.
Key exclusion criteria (3 listed)
- Already has a conservator or representative payee
- An application to assign a payee or conservator has been initiated
- Unable to speak and understand English
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 |
|---|---|---|
| Benefits ManagementMoney-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee. | Behavioural | Benefits Management |
| Illness Management and RecoveryRecovery Oriented Training in Biopsychosocial Model of Stress and How to Cope with Stress | Behavioural | Illness Management and Recovery |
Primary outcome
Change in the Summed score on the Heinrich-Carpenter Quality of Life Measure
Time frame: Change from Week 0 to Week 24
The Heinrich-Carpenter Quality of Life score is derived by summing ratings of individual items after a semi-structured interview. The possible score on any given interview is 0-126. It is a global measure of social functioning with higher scores indicating better functioning.
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 30 Mar 2020.
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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.
Marc I. Rosen, M.D. 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 Phase 1 study testing Benefits Management and Illness Management and Recovery in people with Dual Diagnosis and Schizophrenia, 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 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 30 Mar 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in the Summed score on the Heinrich-Carpenter Quality of Life Measure (time frame: Change from Week 0 to Week 24). 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 30 Mar 2020.