Brief Psychotic Disorder, Psychotic Disorder NOS, Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder
Conditions
Keywords
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS, First Episode
Brief summary
The purpose of this study is to determine how services should be provided to reduce symptoms and improve life functioning for adolescents and adults who have been recently diagnosed with schizophrenia.
Detailed description
Schizophrenia is a major mental illness characterized by psychosis, negative symptoms (e.g., apathy, social withdrawal, anhedonia), and cognitive impairment. Depression and substance abuse commonly co-occur. These individuals have impaired functioning in the areas of work, school, parenting, self-care, independent living, interpersonal relationships, and leisure time. Among adult psychiatric disorders, schizophrenia is the most disabling, and its treatment accounts for a disproportionate share of mental health services. 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 Early Treatment Program (ETP), is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. ETP 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 ETP study aims to compare two early treatment interventions for adolescents and adults experiencing a first episode of psychosis. The clinical centers have been randomly allocated to offer one of the two treatment programs. Both treatment interventions are designed to provide a person with treatment soon after he or she experiences the early signs of schizophrenia. Participants will be offered mental health services such as medication and psychosocial therapy. These strategies are all aimed at promoting symptom reduction and improving life functioning. Participation in this study will last between 2 and 3 years. All participants will first undergo an initial videoconference interview to confirm a diagnosis of schizophrenia, schizoaffective disorder, psychosis NOS, brief psychotic disorder, or schizophreniform disorder. Eligible participants will then be offered mental health services. In addition to the mental health services, participants will participate in a series of research interviews. Participants will be interviewed every 3 months for the first 6 months and then every 6 months for up to 3 years. At the research visit, participants will complete an interview about their symptoms and general quality of life, complete questions about experiences with their illness, their vital signs will be measured, and a blood draw will be collected. At the initial, 12 and 24 month visits, participants will also complete a brief test that assesses skills such as memory, attention and problem solving. Participants will also have monthly telephone interviews about their illness and services that they have received.
Interventions
BEHAVIORALIntegrated Treatment
Integrated program of treatments and services delivered by a coordinated team of providers that includes: * education about schizophrenia and its treatment for the participants and their family members * medication for symptoms and preventing relapse that uses a computerized decision support system * strategies for managing the illness and building personal resilience * help getting back to school or work using a supported employment/education model
BEHAVIORALCommunity Care
Standard mental health treatments and services offered at the local agency that may include : * medication for symptoms and preventing relapse * psychosocial therapy which may include a range of behavioral treatments and supportive services * Case management
Sponsors
Northwell Health
State University of New York - Downstate Medical Center
University of North Carolina, Chapel Hill
University of California, Los Angeles
Dartmouth-Hitchcock Medical Center
Research Foundation for Mental Hygiene, Inc.
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of: * schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder NOS * Any duration of untreated psychosis * Any ethnicity * Ability to participate in research assessments in English * Ability to provide fully informed consent (assent for those under age 18)
Exclusion criteria
* Inability to understand what research participation entails or correctly answer the questions about research participation that are part of the Study Information Review and provide fully informed consent * More than 4 months of prior cumulative treatment with antipsychotic medications * Diagnosis of bipolar disorder, psychotic depression or substance-induced psychotic disorder * Current psychotic disorder due to a general medical condition * Current neurological disorders that would affect diagnosis or prognosis. These would include, but are not limited to seizure disorders, dementing or degenerative disorders, lesions or substantial congenital abnormalities. In most cases, disorders such as headache disorders would not require protocol exclusion * Clinically significant head trauma * Any other serious medical condition that in the opinion of the investigator would seriously impair functioning making the patient unsuitable for the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | Baseline, Month 6, month 12, month 18 and month 24 | This scale measures psychosocial functioning and behavior in people with schizophrenia. The scale contains 21 items rated 0 (no or minimal functioning) to 6 (normal functioning). The results are reported as the total score with a range from 0 to 126. Higher scores indicate a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Measured at baseline, month 6, month 12, month 18, and month 24 | This measures the presence and severity of symptoms of schizophrenia. The scales contains 30 items rated 1 (absent) to 7 (extreme). The results are reported in total score with a range of 30 to 210. Higher scores indicate a worse outcome. |
| Calgary Depression Scale | Measured at baseline, month 6, month 12, month 18, and month 24 | This scale is designed to assess depression in people with schizophrenia. The scale contains 9 items rated 0 (absent) to 3 (severe). The total score is reported and a higher value indicates a worse outcome. Total scores can range from 0 to 27. The data is reported as the estimated mean of the total score. |
| Service Use Rating Form (SURF) | Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean | Measures of treatment services used |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Integrated Treatment Integrated program of treatments and services delivered by a coordinated team of providers.
Integrated Treatment: Integrated program of treatments and services delivered by a coordinated team of providers that includes:
* education about schizophrenia and its treatment for the participants and their family members
* medication for symptoms and preventing relapse that uses a computerized decision support system
* strategies for managing the illness and building personal resilience
* help getting back to school or work using a supported employment/education model | 223 |
| Community Care Standard mental health treatments and services offered at the local agency.
Community Care: Standard mental health treatments and services offered at the local agency that may include :
* medication for symptoms and preventing relapse
* psychosocial therapy which may include a range of behavioral treatments and supportive services
* Case management | 181 |
| Total | 404 |
Baseline characteristics
| Characteristic | Integrated Treatment | Community Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 11 Participants | 23 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 211 Participants | 170 Participants | 381 Participants |
| Age, Continuous | 23.2 years STANDARD_DEVIATION 5.2 | 23.1 years STANDARD_DEVIATION 4.9 | 23.1 years STANDARD_DEVIATION 5.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants | 18 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 163 Participants | 331 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 223 participants | 181 participants | 404 participants |
| Sex: Female, Male Female | 173 Participants | 120 Participants | 293 Participants |
| Sex: Female, Male Male | 50 Participants | 61 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 223 | 0 / 181 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 71 / 223 | 66 / 181 |
Outcome results
Primary
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time
This scale measures psychosocial functioning and behavior in people with schizophrenia. The scale contains 21 items rated 0 (no or minimal functioning) to 6 (normal functioning). The results are reported as the total score with a range from 0 to 126. Higher scores indicate a better outcome.
Time frame: Baseline, Month 6, month 12, month 18 and month 24
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Treatment | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | 6 month | 59.15 score on a scale | Standard Error 1 |
| Integrated Treatment | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | 18 months | 64.93 score on a scale | Standard Error 1.41 |
| Integrated Treatment | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | 12 month | 62.42 score on a scale | Standard Error 1.21 |
| Integrated Treatment | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | 24 months | 67.05 score on a scale | Standard Error 1.59 |
| Integrated Treatment | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | Baseline | 51.25 score on a scale | Standard Error 0.89 |
| Community Care | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | 24 months | 65.02 score on a scale | Standard Error 1.88 |
| Community Care | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | Baseline | 55.13 score on a scale | Standard Error 0.89 |
| Community Care | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | 6 month | 60.08 score on a scale | Standard Error 1.12 |
| Community Care | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | 12 month | 62.12 score on a scale | Standard Error 1.4 |
| Community Care | Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time | 18 months | 63.7 score on a scale | Standard Error 1.66 |
p-value: 0.0145Regression, Linear
Secondary
Calgary Depression Scale
This scale is designed to assess depression in people with schizophrenia. The scale contains 9 items rated 0 (absent) to 3 (severe). The total score is reported and a higher value indicates a worse outcome. Total scores can range from 0 to 27. The data is reported as the estimated mean of the total score.
Time frame: Measured at baseline, month 6, month 12, month 18, and month 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Treatment | Calgary Depression Scale | Month 6 | 3.72 score on a scale | Standard Error 0.2 |
| Integrated Treatment | Calgary Depression Scale | Month 18 | 3.00 score on a scale | Standard Error 0.22 |
| Integrated Treatment | Calgary Depression Scale | Month 12 | 3.31 score on a scale | Standard Error 0.21 |
| Integrated Treatment | Calgary Depression Scale | Month 24 | 2.73 score on a scale | Standard Error 0.24 |
| Integrated Treatment | Calgary Depression Scale | Baseline | 4.71 score on a scale | Standard Error 0.24 |
| Community Care | Calgary Depression Scale | Month 24 | 3.33 score on a scale | Standard Error 0.29 |
| Community Care | Calgary Depression Scale | Baseline | 4.52 score on a scale | Standard Error 0.24 |
| Community Care | Calgary Depression Scale | Month 6 | 3.93 score on a scale | Standard Error 0.21 |
| Community Care | Calgary Depression Scale | Month 12 | 3.68 score on a scale | Standard Error 0.24 |
| Community Care | Calgary Depression Scale | Month 18 | 3.49 score on a scale | Standard Error 0.26 |
Secondary
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score
This measures the presence and severity of symptoms of schizophrenia. The scales contains 30 items rated 1 (absent) to 7 (extreme). The results are reported in total score with a range of 30 to 210. Higher scores indicate a worse outcome.
Time frame: Measured at baseline, month 6, month 12, month 18, and month 24
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Integrated Treatment | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Month 6 | 70.38 score on a scale | Standard Error 1.05 |
| Integrated Treatment | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Month 18 | 65.14 score on a scale | Standard Error 1.29 |
| Integrated Treatment | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Month 12 | 67.41 score on a scale | Standard Error 1.17 |
| Integrated Treatment | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Month 24 | 63.22 score on a scale | Standard Error 1.4 |
| Integrated Treatment | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Baseline | 77.54 score on a scale | Standard Error 0.94 |
| Community Care | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Month 24 | 64.7 score on a scale | Standard Error 1.6 |
| Community Care | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Baseline | 74.69 score on a scale | Standard Error 1.05 |
| Community Care | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Month 6 | 69.70 score on a scale | Standard Error 1.16 |
| Community Care | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Month 12 | 67.63 score on a scale | Standard Error 1.32 |
| Community Care | Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score | Month 18 | 66.04 score on a scale | Standard Error 1.46 |
Secondary
Service Use Rating Form (SURF)
Measures of treatment services used
Time frame: Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Integrated Treatment | Service Use Rating Form (SURF) | 4.53 Services received | Standard Deviation 5.07 |
| Community Care | Service Use Rating Form (SURF) | 3.67 Services received | Standard Deviation 5.93 |