An interventional study of Integrated Treatment and Community Care in Schizophrenia, Schizoaffective Disorder and Schizophreniform Disorder, sponsored by Northwell Health. Completed at 33 sites in United States. Open to participants aged 15 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-10-26.
Sponsored by Northwell Health · Not applicable, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 404 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
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Confirmed SCID DSM-IV clinical diagnosis by trained remote clinical assessor of:
Exclusion Criteria:
Integrated program of treatments and services delivered by a coordinated team of providers.
Behavioral: Integrated Treatment
Standard mental health treatments and services offered at the local agency.
Behavioral: Community Care
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
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
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
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
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
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
| Milestone | Integrated Treatment | Community Care |
|---|---|---|
| Started | 223 | 181 |
| Completed | 147 | 84 |
| Not completed | 76 | 97 |
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.
| score on a scale | Integrated Treatment | Community Care |
|---|---|---|
| Baseline | 51.25 ± 0.89 | 55.13 ± 0.89 |
| 6 month | 59.15 ± 1.0 | 60.08 ± 1.12 |
| 12 month | 62.42 ± 1.21 | 62.12 ± 1.40 |
| 18 months | 64.93 ± 1.41 | 63.7 ± 1.66 |
| 24 months | 67.05 ± 1.59 | 65.02 ± 1.88 |
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.
| score on a scale | Integrated Treatment | Community Care |
|---|---|---|
| Baseline | 77.54 ± 0.94 | 74.69 ± 1.05 |
| Month 6 | 70.38 ± 1.05 | 69.70 ± 1.16 |
| Month 12 | 67.41 ± 1.17 | 67.63 ± 1.32 |
| Month 18 | 65.14 ± 1.29 | 66.04 ± 1.46 |
| Month 24 | 63.22 ± 1.4 | 64.7 ± 1.6 |
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.
| score on a scale | Integrated Treatment | Community Care |
|---|---|---|
| Baseline | 4.71 ± 0.24 | 4.52 ± 0.24 |
| Month 6 | 3.72 ± 0.20 | 3.93 ± 0.21 |
| Month 12 | 3.31 ± 0.21 | 3.68 ± 0.24 |
| Month 18 | 3.00 ± 0.22 | 3.49 ± 0.26 |
| Month 24 | 2.73 ± 0.24 | 3.33 ± 0.29 |
Measures of treatment services used
| Services received | Integrated Treatment | Community Care |
|---|---|---|
| Service Use Rating Form (SURF) | 4.53 ± 5.07 | 3.67 ± 5.93 |
Collected over Adverse events were not collected during this study. Serious Adverse Events (SAEs) were collected throughout the study period which is defined from the time that the informed consent document is signed until 30 days after the last study visit/session, up to 25 months. SAEs occurring more than 30 days after a participant is discontinued from the study will be reported only if the investigator believes that the event may have been caused by a protocol-related procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Integrated Treatment | 1/223 (0.4%) | 71/223 (31.8%) | — |
| Community Care | 0/181 (0%) | 66/181 (36.5%) | — |
| Event | Integrated Treatment | Community Care |
|---|---|---|
| Psychiatric Hospitalization/illnessPsychiatric disorders | 67/223 | 63/181 |
| Medical hospitalization/illnessGeneral disorders | 7/223 | 10/181 |
| Age, Categorical(Participants) | Integrated Treatment | Community Care | Total |
|---|---|---|---|
| <=18 years | 12 | 11 | 23 |
| Between 18 and 65 years | 211 | 170 | 381 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Integrated Treatment | Community Care | Total |
|---|---|---|---|
| Mean | 23.2 ± 5.2 | 23.1 ± 4.9 | 23.1 ± 5.1 |
| Sex: Female, Male(Participants) | Integrated Treatment | Community Care | Total |
|---|---|---|---|
| Female | 173 | 120 | 293 |
| Male | 50 | 61 | 111 |
| Ethnicity (NIH/OMB)(Participants) | Integrated Treatment | Community Care | Total |
|---|---|---|---|
| Hispanic or Latino | 55 | 18 | 73 |
| Not Hispanic or Latino | 168 | 163 | 331 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Integrated Treatment | Community Care | Total |
|---|---|---|---|
| United States | 223 | 181 | 404 |
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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