RAISE ETP: An Integrated Program for the Treatment of First Episode of Psychosis

• Sponsor: Northwell Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01321177
• Collaborator: State University of New York - Downstate Medical Center (Other), University of North Carolina, Chapel Hill (Other), University of California, Los Angeles (Other), Dartmouth-Hitchcock Medical Center (Other), Research Foundation for Mental Hygiene, Inc. (Other), National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 404
• Locations: 33
• Arms: 2
• Duration (Months): 84
• Patients Per Site: 12.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Brief Psychotic Disorder; Psychotic Disorder NOS	Behavioral: Integrated Treatment; Behavioral: Community Care	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 404 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Recovery After an Initial Schizophrenia Episode (RAISE): RAISE Early Treatment Program
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Integrated Treatment Integrated program of treatments and services delivered by a coordinated team of providers.	Behavioral: 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
Active Comparator: Community Care Standard mental health treatments and services offered at the local agency.	Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Fernando Mental Health Center	San Fernando	California	United States	91344
2	Santa ClaritaMental Health Center	Santa Clarita	California	United States	91355
3	Mental Health Center of Denver	Denver	Colorado	United States	80220
4	United Services Inc.	Willimantic	Connecticut	United States	06226
5	Henderson Mental Health Center	Fort Lauderdale	Florida	United States	33319
6	Life management Center of Northwest Florida	Panama City	Florida	United States	32405
7	Central Fulton Community Mental Health Center	Atlanta	Georgia	United States	30303
8	Cobb County Community Services Board	Austell	Georgia	United States	30168
9	Park Center	Fort Wayne	Indiana	United States	46805
10	Community Mental Health Center, Inc.	Lawrenceburg	Indiana	United States	47025
11	Eyerly Ball	Des Moines	Iowa	United States	50309
12	Terrebonne Mental Health Center	Houma	Louisiana	United States	70360
13	River Parish Mental Health Center	Laplace	Louisiana	United States	70068
14	Catholic Social Services of Washtenaw County (CSSW)	Ann Arbor	Michigan	United States	48108
15	Touchstone Innovare	Grand Rapids	Michigan	United States	49503
16	Clinton-Eaton-Ingham Community Mental Health Authority	Lansing	Michigan	United States	48910
17	Human Development Center	Duluth	Minnesota	United States	55805
18	North Point Health and Wellness	Minneapolis	Minnesota	United States	55411
19	Pine Belt Mental Health Clinic	Hattiesburg	Mississippi	United States	39403
20	Burrell Behavioral Health	Columbia	Missouri	United States	65203
21	UMKC School of Pharmacy	Kansas City	Missouri	United States	64108
22	Community Alternatives	Saint Louis	Missouri	United States	63110
23	Burrell Behavioral Health	Springfield	Missouri	United States	65802
24	Community Mental Health Center of Lancaster County	Lincoln	Nebraska	United States	68502
25	The Mental Health Center of Greater Manchester	Manchester	New Hampshire	United States	03101
26	Greater Nashua Mental Health Center @ Community Council	Nashua	New Hampshire	United States	03060
27	Saint Clare's Hospital	Denville	New Jersey	United States	07834
28	University of New Mexico Department of Psychiatry UNM Health Sciences Center	Albuquerque	New Mexico	United States	87131
29	PeaceHealth Oregon/Lane County Behavioral Health Services	Eugene	Oregon	United States	97401
30	Lehigh Valley Hospital Mental Health Clinic	Allentown	Pennsylvania	United States	18104
31	South Shore Mental Health Center	Charlestown	Rhode Island	United States	02813
32	The Providence Center	Providence	Rhode Island	United States	02904
33	Howard Center	Burlington	Vermont	United States	05401

Sponsors and Collaborators

• 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)

Investigators

• Principal Investigator: John Kane, MD, Feinstein Institute for Medical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Kane, Chairman, Psychiatry, Northwell Health
• ClinicalTrials.gov Identifier: NCT01321177
• Other Study ID Numbers: HHSN271200900019C; HHSN271200900019C
• First Posted: Mar 23, 2011
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by John Kane, Chairman, Psychiatry, Northwell Health: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Brief Psychotic Disorder; Psychotic Disorder NOS; First Episode
• Additional relevant MeSH terms: Disease; Schizophrenia; Mental Disorders; Psychotic Disorders

Study Results

Participant Flow

Arm/Group Title	Integrated Treatment	Community Care
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	223	181
COMPLETED	147	84
NOT COMPLETED	76	97

Baseline Characteristics

Arm/Group Title	Integrated Treatment	Community Care	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	223	181	404
Age (Count of Participants)
<=18 years	12 5.4%	11 6.1%	23 5.7%
Between 18 and 65 years	211 94.6%	170 93.9%	381 94.3%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.2 (5.2)	23.1 (4.9)	23.1 (5.1)
Sex: Female, Male (Count of Participants)
Female	173 77.6%	120 66.3%	293 72.5%
Male	50 22.4%	61 33.7%	111 27.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	55 24.7%	18 9.9%	73 18.1%
Not Hispanic or Latino	168 75.3%	163 90.1%	331 81.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	223 100%	181 100%	404 100%

Outcome Measures

1. Primary Outcome

Title	Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time
Description	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

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Integrated Treatment	Community Care
Arm/Group Description	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	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
Measure Participants	223	181
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Integrated Treatment, Community Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0145
	Comments
	Method	Regression, Linear
	Comments

2. Secondary Outcome

Title	Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score
Description	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

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Integrated Treatment	Community Care
Arm/Group Description	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	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
Measure Participants	223	181
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)

3. Secondary Outcome

Title	Calgary Depression Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Integrated Treatment	Community Care
Arm/Group Description	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	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
Measure Participants	223	181
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)

4. Secondary Outcome

Title	Service Use Rating Form (SURF)
Description	Measures of treatment services used
Time Frame	Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean

Outcome Measure Data

Analysis Population Description

Intent to Treat

Arm/Group Title	Integrated Treatment	Community Care
Arm/Group Description	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	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
Measure Participants	223	181
Mean (Standard Deviation) [Services received]	4.53 (5.07)	3.67 (5.93)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	Serious Adverse Events (SAEs) are defined as events that result in Death, inpatient hospitalization, a life-threatening experience, medically significant event not requiring hospitalization, persistent or significant disability/capacity, congenital anomaly/birth defect. Suicide attempts will be reported as SAEs, regardless of whether or not they result in hospitalization.
Arm/Group Title	Integrated Treatment		Community Care
Arm/Group Description	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		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
All Cause Mortality
	Integrated Treatment		Community Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/223 (0.4%)		0/181 (0%)
Serious Adverse Events
	Integrated Treatment		Community Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	71/223 (31.8%)		66/181 (36.5%)
General disorders
Medical hospitalization/illness	7/223 (3.1%)	8	10/181 (5.5%)	12
Psychiatric disorders
Psychiatric Hospitalization/illness	67/223 (30%)	121	63/181 (34.8%)	134
Other (Not Including Serious) Adverse Events
	Integrated Treatment		Community Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.