SchizophreniaNCT01570972
Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis
A study testing Group Cognitive Behavioral Therapy and Multifamily Group Psychoeducation in people with Schizophrenia and Schizoaffective Disorder, run by University of Arizona at 1 site in United States.
Trial summary
Multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT] are evidence-based treatments for first episode psychosis. However, like all treatments for psychotic disorders, neither MFG nor GCBT are perfect-some individuals who receive these interventions still experience a worsening of… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features
- What is being tested?
- Group Cognitive Behavioral Therapy and Multifamily Group Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 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
Who may be able to join
- 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, Camberwell Family Interview, and family interaction task.
Who cannot join
- Diagnosis of a psychotic disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Department of Psychiatry
Tucson, Arizona, 85724
About this study
Multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT] are evidence-based treatments for first episode psychosis. However, like all treatments for psychotic disorders, neither MFG nor GCBT are perfect-some individuals who receive these interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms through which these interventions produce their clinical benefits and identifying the factors that may maximize an individual's response to MFG and GCBT could improve the clinical benefits facilitated by these two interventions.
Read the detailed description
Background
There is growing evidence that the majority of the psychosocial deterioration that accompanies psychotic disorders occurs during the first few years of illness and that the prevention or delay of early deterioration may be associated with a better course of illness. Two interventions which have been shown to improve the course of recent-onset psychosis are multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT]. Both family psychoeducation and cognitive behavioral therapy have been recommended as components of usual care for psychotic disorders by the Schizophrenia Patient Oriented Research Team convened by the U.S. Department of Health and Human Services (10) as well as other international health organizations. However, like all treatments for psychotic disorders, neither MFG nor GCBT are perfect-some individuals who receive these interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms through which these interventions produce their clinical benefits and identifying the factors that may maximize an individual's response to MFG and GCBT could improve the clinical benefits facilitated by these two interventions.
Purpose and Objectives
The goal of this study is to clarify the mechanisms through which MFG and GCBT produce their clinical benefits (i.e., mediators) and identify the factors that may maximize an individual's response to these two empirically-validated interventions (i.e., moderators).
Methods
All participants will be provided with 2 years of of GCBT and MFG and will complete regular assessments with regard to clinical and functional outcomes as well as potential mediators and moderators of these outcomes.
Significance of the Study
Clarifying the mechanisms through which these interventions produce their clinical benefits and identifying the factors that may maximize an individual's response to MFG and GCBT could lead to improvements in the treatment of first-episode psychosis.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depression With Psychotic Features, Psychotic Disorder Not Otherwise Specified (NOS)
- Being tested
- Group Cognitive Behavioral Therapy, Multifamily Group Psychoeducation
- Keywords
- schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depression with psychotic features, recent-onset psychosis, first-episode psychosis, cognitive behavioral therapy, multifamily group 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.
Group Cognitive Behavioral TherapyBehavioural
weekly
Multifamily Group PsychoeducationBehavioural
twice monthly
| Study group | Role | What they receive |
|---|---|---|
| MFG and GCBT | Other | There is a single arm for this study. All participants will be able to participate in MFG and GCBT Receives: Behavioral: Group Cognitive Behavioral Therapy; Behavioral: Multifamily Group Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months
General level of functioning to be assessed using the General Assessment of Functioning (GAF) scale
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Change from baseline in self-reported Physical Health at 6 months, 12 months, 18 months, and 24 months
Self-reported physical health assessed using the RAND-36 Health Survey
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Change from baseline in Social and vocational Functioning at 6 months, 12 months, 18 months, and 24 months
Social and Vocational functioning to be assessed using the Social Functioning Scale
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Change from baseline in Stage of Recovery at 6 months, 12 months, 18 months, and 24 months
Stage of recovery assessed using the Stage of Recovery Instrument
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Change from baseline Service Utilization at 6 months, 12 months, 18 months, and 24 months
Service utilization as assessed using the Service Utilization Record Form
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Change from Baseline Quality of Life at 6 months, 12 months, 18 months, and 24 months
Quality of Life as assessed using the WHO Quality of Life Scale Brief
Measured: Baseline, 6 months, 12 months, 18 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startFeb 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 (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Breitborde, University of Arizona
- Investigators
- Nicholas Breitborde, Ph.D., Principal investigator, The Ohio State Univerity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570972
- Sponsor's protocol ID
- U. Az IRB 09-1113-02
- Status last verified
- May 2020
- First submitted
- 7 Nov 2011
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Moe AM, Wastler HM, Pine JG, Breitborde NJK. Metacognitive Skills Training and Computerized Cognitive Remediation among Individuals with First-Episode Psychosis: Influence on Social Cognition. Psychosis. 2023;15(4):418-423. doi: 10.1080/17522439.2022.2111595. Epub 2023 Jan 4.
PubMed 38053744Breitborde NJK, Bell EK, Woolverton C, Pine JG, Waslter H, Moe AM. Cost Utility of cognition-enhancing interventions for individuals with first-episode psychosis: a naturalistic evaluation. Cost Eff Resour Alloc. 2021 Jul 1;19(1):36. doi: 10.1186/s12962-021-00292-6.
PubMed 34210341Breitborde NJ, Bell EK, Dawley D, Woolverton C, Ceaser A, Waters AC, Dawson SC, Bismark AW, Polsinelli AJ, Bartolomeo L, Simmons J, Bernstein B, Harrison-Monroe P. The Early Psychosis Intervention Center (EPICENTER): development and six-month outcomes of an American first-episode psychosis clinical service. BMC Psychiatry. 2015 Oct 28;15:266. doi: 10.1186/s12888-015-0650-3.
PubMed 26511605
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
- Mediators and Moderators of Treatment Outcome in Recent-Onset Psychosis
- ClinicalTrials.gov ID
- NCT01570972
- Acronym / sponsor ID
- U. Az IRB 09-1113-02
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder With Psychotic Features, Major Depression With Psychotic Features, Psychotic Disorder Not Otherwise Specified (NOS)
- Keywords
- schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, major depression with psychotic features, recent-onset psychosis, first-episode psychosis, cognitive behavioral therapy, multifamily group psychoeducation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Apr 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.
Multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT] are evidence-based treatments for first episode psychosis. However, like all treatments for psychotic disorders, neither MFG nor GCBT are perfect-some individuals who receive these interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms through which these interventions produce their clinical benefits and identifying the factors that may maximize an individual's response to MFG and GCBT could improve the clinical benefits facilitated by these two interventions.
Detailed description
Background
There is growing evidence that the majority of the psychosocial deterioration that accompanies psychotic disorders occurs during the first few years of illness and that the prevention or delay of early deterioration may be associated with a better course of illness. Two interventions which have been shown to improve the course of recent-onset psychosis are multifamily group psychoeducation [MFG] and group cognitive behavioral therapy [GCBT]. Both family psychoeducation and cognitive behavioral therapy have been recommended as components of usual care for psychotic disorders by the Schizophrenia Patient Oriented Research Team convened by the U.S. Department of Health and Human Services (10) as well as other international health organizations. However, like all treatments for psychotic disorders, neither MFG nor GCBT are perfect-some individuals who receive these interventions still experience a worsening of psychotic symptoms. Clarifying the mechanisms through which these interventions produce their clinical benefits and identifying the factors that may maximize an individual's response to MFG and GCBT could improve the clinical benefits facilitated by these two interventions.
Purpose and Objectives
The goal of this study is to clarify the mechanisms through which MFG and GCBT produce their clinical benefits (i.e., mediators) and identify the factors that may maximize an individual's response to these two empirically-validated interventions (i.e., moderators).
Methods
All participants will be provided with 2 years of of GCBT and MFG and will complete regular assessments with regard to clinical and functional outcomes as well as potential mediators and moderators of these outcomes.
Significance of the Study
Clarifying the mechanisms through which these interventions produce their clinical benefits and identifying the factors that may maximize an individual's response to MFG and GCBT could lead to improvements in the treatment of first-episode psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MFG and GCBT | Other | Behavioral: Group Cognitive Behavioral Therapy, Behavioral: Multifamily Group PsychoeducationThere is a single arm for this study. All participants will be able to participate in MFG and GCBT |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of a psychotic disorder.
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 |
|---|---|---|
| Group Cognitive Behavioral Therapyweekly | Behavioural | MFG and GCBT |
| Multifamily Group Psychoeducationtwice monthly | Behavioural | MFG and GCBT |
Primary outcome
Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
General level of functioning to be assessed using the General Assessment of Functioning (GAF) scale
Change from baseline in self-reported Physical Health at 6 months, 12 months, 18 months, and 24 months
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Self-reported physical health assessed using the RAND-36 Health Survey
Change from baseline in Social and vocational Functioning at 6 months, 12 months, 18 months, and 24 months
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Social and Vocational functioning to be assessed using the Social Functioning Scale
Change from baseline in Stage of Recovery at 6 months, 12 months, 18 months, and 24 months
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Stage of recovery assessed using the Stage of Recovery Instrument
Change from baseline Service Utilization at 6 months, 12 months, 18 months, and 24 months
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Service utilization as assessed using the Service Utilization Record Form
Change from Baseline Quality of Life at 6 months, 12 months, 18 months, and 24 months
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Quality of Life as assessed using the WHO Quality of Life Scale Brief
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.
- Derived from this study: PubMed 38053744Moe AM, Wastler HM, Pine JG, Breitborde NJK. Metacognitive Skills Training and Computerized Cognitive Remediation among Individuals with First-Episode Psychosis: Influence on Social Cognition. Psychosis. 2023;15(4):418-423. doi: 10.1080/17522439.2022.2111595. Epub 2023 Jan 4.
- Derived from this study: PubMed 34210341Breitborde NJK, Bell EK, Woolverton C, Pine JG, Waslter H, Moe AM. Cost Utility of cognition-enhancing interventions for individuals with first-episode psychosis: a naturalistic evaluation. Cost Eff Resour Alloc. 2021 Jul 1;19(1):36. doi: 10.1186/s12962-021-00292-6.
- Derived from this study: PubMed 26511605Breitborde NJ, Bell EK, Dawley D, Woolverton C, Ceaser A, Waters AC, Dawson SC, Bismark AW, Polsinelli AJ, Bartolomeo L, Simmons J, Bernstein B, Harrison-Monroe P. The Early Psychosis Intervention Center (EPICENTER): development and six-month outcomes of an American first-episode psychosis clinical service. BMC Psychiatry. 2015 Oct 28;15:266. doi: 10.1186/s12888-015-0650-3.
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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
The Ohio State Univerity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Behavioral Therapy and Multifamily Group Psychoeducation in people with Schizophrenia and Schizoaffective Disorder, 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?
The sponsor lists 7 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 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?
Change from baseline in General level of functioning at 6 months, 12 months, 18 months, and 24 months (time frame: Baseline, 6 months, 12 months, 18 months, 24 months). The study lists 6 primary outcomes in all. 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 NCT01570972, which also lists 3 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.