SchizophreniaNCT01216891
Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis
A study testing Multi-element, team-oriented treatment in people with Schizophrenia and Schizoaffective Disorder, run by Research Foundation for Mental Hygiene, Inc. at 2 sites in United States.
Trial summary
This study will assess the effectiveness of an experimental treatment intervention for adolescents and adults who have experienced their first episode of psychosis during the past two years. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- What is being tested?
- Multi-element, team-oriented treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Aug 2016
- 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 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age range: 15-35 years old (16-35 years old in New York)
- Diagnosis of schizophrenia, schizoaffective and schizophreniform disorder, delusional disorder, or psychosis not otherwise specified (NOS)
- Duration of psychotic symptoms > 1 week and < 2 years
- Ability to provide informed consent
- Ability to speak and understand English
- Anticipated availability to participate in the intervention for at least 1 year
- RAISE-DUP: participants must have been enrolled in the RAISE study
Who cannot join
- Medical conditions which impair function independent of psychosis
- Other diagnoses associated with psychosis:
- Substance-induced psychotic disorder
- Psychotic affective disorder (major depressive or manic episode with psychotic features)
- Psychotic disorder due to a general medication condition
- Mental retardation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland Medical Center, Carruthers Clinic
Baltimore, Maryland, 21230
Washington Heights Community Service Clinic
New York, New York, 10032
About this study
Official title: Recovery After an Initial Schizophrenia Episode (RAISE): The RAISE Connection Program Duration of Untreated Psychosis (DUP)
This study will assess the effectiveness of an experimental treatment intervention for adolescents and adults who have experienced their first episode of psychosis during the past two years.
The DUP sub-study will collect pathways to care information that will be used to inform the development and pilot testing of strategies that aim to reduce DUP among individuals experiencing a first episode of psychosis.
Read the detailed description
This study is part of the National Institute of Mental Health's Recovery After an Initial Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. This study, the RAISE Connection Program, is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. The Connection Program is being supported in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the NIMH, National Institutes of Health, Department of Health and Human Services. The Connection Program aims to to assess the effectiveness of a Team-based intervention for individuals with a first psychotic episode, observing outcomes over time for our study participants. When tracking outcomes, the Connection Program will make comparisons with what is known about the natural history of untreated first episode of psychosis as well as usual care outcomes from other experimental studies.
This study is for people who have experienced symptoms such as hallucinations, unusual thoughts or beliefs, or disorganized thinking for the first time during the past two years. Without treatment, many people have a difficult time with these symptoms, which can be very upsetting and also make it hard to socialize, study, or work.
People have different wishes and needs, and it is not clear what combination of treatments and services is best for any one person. There are many possible treatments and services, such as medications, talk therapy, case management, and school and job counseling. This study will adapt and evaluate the impact of a comprehensive and integrated treatment intervention for first episode psychosis to be delivered in real-world practice settings to promote symptomatic recovery, minimize disability, and maximize social, academic, and vocational functioning.
Participation in this study will last up to 2 years. At the baseline visit, participants will be enrolled to receive the experimental intervention. During the study period, participants will take part in research interviews every three to six months for a total of 6 interviews. Each of these research interviews will take 1.5 to 3 hours to complete. Assessments of participants' health condition, overall function and illness severity, employment status, academic performance, and social functioning will be conducted during these research interviews. In addition to assessing functioning and illness severity, this study will also address substance abuse and utilization of healthcare services. Participants will also be measured for their height, weight and waist circumference. This portion of the study concluded in December 2013.
The RAISE-DUP contract modification seeks additional information on the referral pathways that resulted in enrollment in the RAISE Connection Program from individuals who participated in RAISE Connection Program services and their family members. Information gathered through qualitative research interviews will be used to inform the development and pilot testing of outreach, education, and engagement intervention strategies, to serve the larger goal of reducing the duration of untreated psychosis among individuals experiencing a first episode of psychosis.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Psychosis
- Being tested
- Multi-element, team-oriented treatment
- Keywords
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Psychosis, First episode
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Schizophrenia, Paranoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-element, team-oriented treatmentBehavioural
Participants will receive treatment and services based on their needs coordinated by a small team that is led by a clinical coordinator. Services that are available to the participants include social skills training, medication treatment to address symptoms, education and employment advising, and substance use treatment.
| Study group | Role | What they receive |
|---|---|---|
| Team-based treatment | Experimental | Not described Receives: Behavioral: Multi-element, team-oriented treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
This measures occupational functioning, social functioning and symptom severity.
Measured: Measured at baseline
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Measured: Measured at Month 6
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Measured: Measured at Month 12
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Measured: Measured at Month 18
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Measured: Measured at Month 24
Pathways to Care Qualitative Interview
This assessment gathers information on help-seeking events and participant recommendations.
Measured: Measured at baseline
Secondary outcomes (15)
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
Measured: Measured at baseline
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Measured: Measured at baseline
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
Measured: Measured at baseline
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
Measured: Measured at Month 6
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
Measured: Measured at Month 12
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
Measured: Measured at Month 18
The Clinical Global Impression (CGI) - Severity scale
This assesses the level of severity of illness.
Measured: Measured at Month 24
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Measured: Measured at Month 6
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Measured: Measured at Month 12
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Measured: Measured at Month 18
Calgary Depression Scale
This assesses depression in people with schizophrenia.
Measured: Measured at Month 24
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
Measured: Measured at Month 6
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
Measured: Measured at Month 12
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
Measured: Measured at Month 18
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
This measures the presence and severity of symptoms of schizophrenia.
Measured: Measured at Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Maryland, New York State Office of Mental Health (OMH), Maryland Department of Health and Mental Hygiene
- Responsible party
- Principal investigator, Lisa Dixon, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Lisa Dixon, MD, Principal investigator, Columbia UniversityMelanie Bennett, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216891
- Sponsor's protocol ID
- RAISE Connection
- Other IDs
- HHSN271200900020C
- Status last verified
- Nov 2016
- First submitted
- 4 Oct 2010
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery After an Initial Schizophrenia Episode (RAISE): The RAISE Connection Program Duration of Untreated Psychosis (DUP)
- ClinicalTrials.gov ID
- NCT01216891
- Acronym / sponsor ID
- RAISE Connection
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Psychosis
- Keywords
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Psychosis, First episode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Maryland, New York State Office of Mental Health (OMH), Maryland Department of Health and Mental Hygiene
- Study start
- Oct 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 7 Oct 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.
This study will assess the effectiveness of an experimental treatment intervention for adolescents and adults who have experienced their first episode of psychosis during the past two years.
The DUP sub-study will collect pathways to care information that will be used to inform the development and pilot testing of strategies that aim to reduce DUP among individuals experiencing a first episode of psychosis.
Detailed description
This study is part of the National Institute of Mental Health's Recovery After an Initial Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. This study, the RAISE Connection Program, is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. The Connection Program is being supported in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the NIMH, National Institutes of Health, Department of Health and Human Services. The Connection Program aims to to assess the effectiveness of a Team-based intervention for individuals with a first psychotic episode, observing outcomes over time for our study participants. When tracking outcomes, the Connection Program will make comparisons with what is known about the natural history of untreated first episode of psychosis as well as usual care outcomes from other experimental studies.
This study is for people who have experienced symptoms such as hallucinations, unusual thoughts or beliefs, or disorganized thinking for the first time during the past two years. Without treatment, many people have a difficult time with these symptoms, which can be very upsetting and also make it hard to socialize, study, or work.
People have different wishes and needs, and it is not clear what combination of treatments and services is best for any one person. There are many possible treatments and services, such as medications, talk therapy, case management, and school and job counseling. This study will adapt and evaluate the impact of a comprehensive and integrated treatment intervention for first episode psychosis to be delivered in real-world practice settings to promote symptomatic recovery, minimize disability, and maximize social, academic, and vocational functioning.
Participation in this study will last up to 2 years. At the baseline visit, participants will be enrolled to receive the experimental intervention. During the study period, participants will take part in research interviews every three to six months for a total of 6 interviews. Each of these research interviews will take 1.5 to 3 hours to complete. Assessments of participants' health condition, overall function and illness severity, employment status, academic performance, and social functioning will be conducted during these research interviews. In addition to assessing functioning and illness severity, this study will also address substance abuse and utilization of healthcare services. Participants will also be measured for their height, weight and waist circumference. This portion of the study concluded in December 2013.
The RAISE-DUP contract modification seeks additional information on the referral pathways that resulted in enrollment in the RAISE Connection Program from individuals who participated in RAISE Connection Program services and their family members. Information gathered through qualitative research interviews will be used to inform the development and pilot testing of outreach, education, and engagement intervention strategies, to serve the larger goal of reducing the duration of untreated psychosis among individuals experiencing a first episode of psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Team-based treatment | Experimental | Behavioral: Multi-element, team-oriented treatment |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age range: 15-35 years old (16-35 years old in New York)
- Diagnosis of schizophrenia, schizoaffective and schizophreniform disorder, delusional disorder, or psychosis not otherwise specified (NOS)
- Duration of psychotic symptoms > 1 week and < 2 years
- Ability to provide informed consent
- Ability to speak and understand English
Key exclusion criteria (6 listed)
- Medical conditions which impair function independent of psychosis
- Other diagnoses associated with psychosis:
- Substance-induced psychotic disorder
- Psychotic affective disorder (major depressive or manic episode with psychotic features)
- Psychotic disorder due to a general medication condition
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 |
|---|---|---|
| Multi-element, team-oriented treatmentParticipants will receive treatment and services based on their needs coordinated by a small team that is led by a clinical coordinator. Services that are available to the participants include social skills training, medication treatment to address symptoms, education and employment advising, and substance use treatment. | Behavioural | Team-based treatment |
Primary outcome
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time frame: Measured at baseline
This measures occupational functioning, social functioning and symptom severity.
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time frame: Measured at Month 6
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time frame: Measured at Month 12
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time frame: Measured at Month 18
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF)
Time frame: Measured at Month 24
Pathways to Care Qualitative Interview
Time frame: Measured at baseline
This assessment gathers information on help-seeking events and participant recommendations.
15 secondary outcomes
The Clinical Global Impression (CGI) - Severity scale
Time frame: Measured at baseline
Calgary Depression Scale
Time frame: Measured at baseline
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: Measured at baseline
The Clinical Global Impression (CGI) - Severity scale
Time frame: Measured at Month 6
The Clinical Global Impression (CGI) - Severity scale
Time frame: Measured at Month 12
The Clinical Global Impression (CGI) - Severity scale
Time frame: Measured at Month 18
The Clinical Global Impression (CGI) - Severity scale
Time frame: Measured at Month 24
Calgary Depression Scale
Time frame: Measured at Month 6
Calgary Depression Scale
Time frame: Measured at Month 12
Calgary Depression Scale
Time frame: Measured at Month 18
Calgary Depression Scale
Time frame: Measured at Month 24
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: Measured at Month 6
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: Measured at Month 12
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: Measured at Month 18
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: Measured at Month 24
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 3 Nov 2016.
- Related InfoLink provided by the sponsor.
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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.
Lisa Dixon, MD principal investigator
Columbia University
Melanie Bennett, PhD principal investigator
University of Maryland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-element, team-oriented treatment in people with Schizophrenia and Schizoaffective Disorder, run by Research Foundation for Mental Hygiene, Inc. at 2 sites 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 6 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) (time frame: Measured at baseline). 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?
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 3 Nov 2016.