Recent-Onset PsychosisNCT01196286
Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
A study testing Multifamily Group Psychoeducation (MFG) and Cognitive Remediation (CR) in people with Recent-Onset Psychosis and Schizophrenia, run by University of Arizona at 1 site in United States.
Trial summary
The goal of this study is to determine whether pairing multifamily group psychoeducation with cognitive remediation may facilitate improved outcomes among individuals with recent-onset psychosis. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Recent-Onset Psychosis, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Multifamily Group Psychoeducation (MFG) and Cognitive Remediation (CR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2017
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria (Individual with Recent-Onset Psychosis):
- Diagnosis of a non-substance induced psychotic disorder per DSM-IV-TR criteria determined using the Structured Clinical Interview for the DSM-IV.
- Age between 18-35
- Willing to participate in interventions at University of Arizona Medical Center, South Campus
- Willing to complete research assessments
- Duration of psychotic symptoms of less than 5 years determined using the Symptom Onset in Schizophrenia inventory
- Able to provide informed consent
- Fluent in English
- Must have a family caregiver who is willing to participate in the study
- Willing to allow videotaping of multifamily group therapy sessions.
- No evidence of mental retardation as defined as never having qualified to receive services from the Arizona Department of Economic Security, Division of Developmental Disabilities.
Exclusion Criteria (Individual with Recent-Onset Psychosis):
- Failure to meet inclusion criteria
Inclusion Criteria (Caregiving Relative of Individual with Recent-Onset Psychosis):
- Must be someone that the individual with recent-onset psychosis identifies as providing support and care to the individual with recent-onset psychosis. Does not need to be a biological relative.
- Must spend considerable time with the individual with recent-onset psychosis as defined at 10 hours or more of direct contact per week.
- Willing to participate in participate in family intervention at University of Arizona Medical Center, South Campus for 2 years
- Willing to complete research assessments
- Able to provide informed consent
- Fluent in English
- Willing to allow videotaping of multifamily group sessions.
Exclusion Criteria (Caregiving Relative of Individual with Recent-Onset Psychosis):
- Failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine whether pairing multifamily group psychoeducation with cognitive remediation may facilitate improved outcomes among individuals with recent-onset psychosis.
- Conditions
- Recent-Onset Psychosis, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depression With Psychotic Features, Psychotic Disorder Not Otherwise Specified (NOS)
- Being tested
- Multifamily Group Psychoeducation (MFG), Cognitive Remediation (CR)
- Keywords
- First-episode psychosis, cognitive remediation, family psychoeducation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifamily Group Psychoeducation (MFG)Behavioural
Participation in multifamily psychoeducation comprised of (i) three individual sessions with family and individual with psychosis, (ii) one psychoeducational workshop, and (iiI) twice monthly multifamily meetings to complete structured problem-solving activity
Cognitive Remediation (CR)Behavioural
Computer exercises designed to improve cognitive functioning (3hr/wk).
| Study group | Role | What they receive |
|---|---|---|
| MFG and CR | Experimental | Subjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR) Receives: Behavioral: Multifamily Group Psychoeducation (MFG); Behavioral: Cognitive Remediation (CR) |
| MFG | Active comparator | Subjects provided with only multifamily group psychoeducation (MFG) Receives: Behavioral: Multifamily Group Psychoeducation (MFG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic Symptoms/Relapse Assessed Once Per Week
Measured: 9 months
Secondary outcomes (1)
Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization
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 posted8 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Recent-Onset PsychosisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Mental Health Research
- Responsible party
- Principal investigator, Nicholas Breitborde, University of Arizona
- Investigators
- Nicholas Breitborde, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196286
- Sponsor's protocol ID
- 2010-BN-07
- Status last verified
- May 2020
- First submitted
- 3 Sep 2010
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Breitborde NJ, Woods SW, Srihari VH. Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis. Psychiatr Serv. 2009 Nov;60(11):1477-83. doi: 10.1176/ps.2009.60.11.1477.
PubMed 19880465Rubinstein E, Breitborde NJ, Jenkins JH. Anthropological intervention early in psychosis. Early Interv Psychiatry. 2010 May;4(2):108-10. doi: 10.1111/j.1751-7893.2010.00175.x. No abstract available.
PubMed 20536965Breitborde NJ, Srihari VH, Pollard JM, Addington DN, Woods SW. Mediators and moderators in early intervention research. Early Interv Psychiatry. 2010 May;4(2):143-52. doi: 10.1111/j.1751-7893.2010.00177.x.
PubMed 20536970Breitborde NJ, Moreno FA, Mai-Dixon N, Peterson R, Durst L, Bernstein B, Byreddy S, McFarlane WR. Multifamily group psychoeducation and cognitive remediation for first-episode psychosis: a randomized controlled trial. BMC Psychiatry. 2011 Jan 12;11:9. doi: 10.1186/1471-244X-11-9.
PubMed 21226941
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifamily Psychoeducation and Cognitive Remediation for Recent-Onset Psychosis
- ClinicalTrials.gov ID
- NCT01196286
- Acronym / sponsor ID
- 2010-BN-07
- Conditions
- Recent-Onset Psychosis, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depression With Psychotic Features, Psychotic Disorder Not Otherwise Specified (NOS)
- Keywords
- First-episode psychosis, cognitive remediation, family psychoeducation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Institute for Mental Health Research
- Study start
- Jun 2010
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Sep 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 goal of this study is to determine whether pairing multifamily group psychoeducation with cognitive remediation may facilitate improved outcomes among individuals with recent-onset psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MFG and CR | Experimental | Behavioral: Multifamily Group Psychoeducation (MFG), Behavioral: Cognitive Remediation (CR)Subjects provided with both multifamily psychoeducation (MFG) and cognitive remediation (CR) |
| MFG | Active comparator | Behavioral: Multifamily Group Psychoeducation (MFG)Subjects provided with only multifamily group psychoeducation (MFG) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Multifamily Group Psychoeducation (MFG)Participation in multifamily psychoeducation comprised of (i) three individual sessions with family and individual with psychosis, (ii) one psychoeducational workshop, and (iiI) twice monthly multifamily meetings to complete structured problem-solving activity | Behavioural | MFG, MFG and CR |
| Cognitive Remediation (CR)Computer exercises designed to improve cognitive functioning (3hr/wk). | Behavioural | MFG and CR |
Primary outcome
Psychotic Symptoms/Relapse Assessed Once Per Week
Time frame: 9 months
1 secondary outcome
Depression, Anxiety, Emotional Awareness, Cognitive Functioning, Problem-Solving Ability, Quality of Life, Social Functioning, Service Utilization
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 21 May 2020.
- Background: PubMed 19880465Breitborde NJ, Woods SW, Srihari VH. Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis. Psychiatr Serv. 2009 Nov;60(11):1477-83. doi: 10.1176/ps.2009.60.11.1477.
- Background: PubMed 20536965Rubinstein E, Breitborde NJ, Jenkins JH. Anthropological intervention early in psychosis. Early Interv Psychiatry. 2010 May;4(2):108-10. doi: 10.1111/j.1751-7893.2010.00175.x. No abstract available.
- Background: PubMed 20536970Breitborde NJ, Srihari VH, Pollard JM, Addington DN, Woods SW. Mediators and moderators in early intervention research. Early Interv Psychiatry. 2010 May;4(2):143-52. doi: 10.1111/j.1751-7893.2010.00177.x.
- Derived from this study: PubMed 21226941Breitborde NJ, Moreno FA, Mai-Dixon N, Peterson R, Durst L, Bernstein B, Byreddy S, McFarlane WR. Multifamily group psychoeducation and cognitive remediation for first-episode psychosis: a randomized controlled trial. BMC Psychiatry. 2011 Jan 12;11:9. doi: 10.1186/1471-244X-11-9.
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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.
Nicholas Breitborde, Ph.D. principal investigator
Ohio State 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 Multifamily Group Psychoeducation (MFG) and Cognitive Remediation (CR) in people with Recent-Onset Psychosis and Schizophrenia, run by University of Arizona 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?
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 21 May 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.
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?
Psychotic Symptoms/Relapse Assessed Once Per Week (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 NCT01196286, which also lists 4 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 21 May 2020.