Trial Outcomes & Findings for An Integrated Program for the Treatment of First Episode of Psychosis (NCT NCT01321177)

Last Updated: 2021-10-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

404 participants

Primary outcome timeframe

Baseline, Month 6, month 12, month 18 and month 24

Results posted on

2021-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	223	181
Overall Study COMPLETED	147	84
Overall Study NOT COMPLETED	76	97

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Integrated Program for the Treatment of First Episode of Psychosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Integrated Treatment n=223 Participants 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	Community Care n=181 Participants 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 n=404 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	211 Participants n=5 Participants	170 Participants n=7 Participants	381 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	23.2 years STANDARD_DEVIATION 5.2 • n=5 Participants	23.1 years STANDARD_DEVIATION 4.9 • n=7 Participants	23.1 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	120 Participants n=7 Participants	293 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	61 Participants n=7 Participants	111 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	55 Participants n=5 Participants	18 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants	163 Participants n=7 Participants	331 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	223 participants n=5 Participants	181 participants n=7 Participants	404 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 6, month 12, month 18 and month 24

Population: Intent to treat population

Outcome measures

Outcome measures
Measure	Integrated Treatment n=223 Participants 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	Community Care n=181 Participants 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
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time Baseline	51.25 score on a scale Standard Error 0.89	55.13 score on a scale Standard Error 0.89
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time 6 month	59.15 score on a scale Standard Error 1.0	60.08 score on a scale Standard Error 1.12
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time 12 month	62.42 score on a scale Standard Error 1.21	62.12 score on a scale Standard Error 1.40
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time 18 months	64.93 score on a scale Standard Error 1.41	63.7 score on a scale Standard Error 1.66
Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time 24 months	67.05 score on a scale Standard Error 1.59	65.02 score on a scale Standard Error 1.88

SECONDARY outcome

Timeframe: Measured at baseline, month 6, month 12, month 18, and month 24

Population: Intent to treat

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.

Outcome measures

Outcome measures
Measure	Integrated Treatment n=223 Participants 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	Community Care n=181 Participants 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
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score Baseline	77.54 score on a scale Standard Error 0.94	74.69 score on a scale Standard Error 1.05
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score Month 6	70.38 score on a scale Standard Error 1.05	69.70 score on a scale Standard Error 1.16
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score Month 12	67.41 score on a scale Standard Error 1.17	67.63 score on a scale Standard Error 1.32
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score Month 18	65.14 score on a scale Standard Error 1.29	66.04 score on a scale Standard Error 1.46
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score Month 24	63.22 score on a scale Standard Error 1.4	64.7 score on a scale Standard Error 1.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Integrated Treatment n=223 Participants 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	Community Care n=181 Participants 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
Calgary Depression Scale Baseline	4.71 score on a scale Standard Error 0.24	4.52 score on a scale Standard Error 0.24
Calgary Depression Scale Month 6	3.72 score on a scale Standard Error 0.20	3.93 score on a scale Standard Error 0.21
Calgary Depression Scale Month 12	3.31 score on a scale Standard Error 0.21	3.68 score on a scale Standard Error 0.24
Calgary Depression Scale Month 18	3.00 score on a scale Standard Error 0.22	3.49 score on a scale Standard Error 0.26
Calgary Depression Scale Month 24	2.73 score on a scale Standard Error 0.24	3.33 score on a scale Standard Error 0.29

SECONDARY outcome

Timeframe: Measured at baseline and then monthly for months 1 through 24; reported as the monthly mean

Population: Intent to Treat

Measures of treatment services used

Outcome measures

Outcome measures
Measure	Integrated Treatment n=223 Participants 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	Community Care n=181 Participants 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
Service Use Rating Form (SURF)	4.53 Services received Standard Deviation 5.07	3.67 Services received Standard Deviation 5.93

Adverse Events

Integrated Treatment

Serious events: 71 serious events

Other events: 0 other events

Deaths: 1 deaths

Community Care

Serious events: 66 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Integrated Treatment n=223 participants at risk 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	Community Care n=181 participants at risk 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
Psychiatric disorders Psychiatric Hospitalization/illness	30.0% 67/223 • Number of events 121 • 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. 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.	34.8% 63/181 • Number of events 134 • 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. 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.
General disorders Medical hospitalization/illness	3.1% 7/223 • Number of events 8 • 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. 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.	5.5% 10/181 • Number of events 12 • 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. 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.

Other adverse events

Adverse event data not reported

Additional Information

Patricia Marcy

Northwell Health

Phone: 347-439-8035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place