EDIP: Psychosis: Early Detection, Intervention and Prevention

• Sponsor: MaineHealth (Other)
• Overall Status: Completed
• CT.gov ID: NCT01597141
• Collaborator: Columbia University (Other), Harvard University (Other), University of California, Irvine (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 139
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The primary aim of this application is to conduct a randomized, controlled clinical trial of a specialized mental health service delivery system specifically developed for prodromal psychotic disorders. The intervention is Family-aided Assertive Community Treatment (FACT). The goal of the treatment is prevention of psychosis and disability. This study will assess experimentally the clinical effectiveness of this new type of mental health service. Other domains of outcome include cognitive dysfunction and functional disability.

Condition or Disease	Intervention/Treatment	Phase
Prodromal Schizophrenia; Psychotic Disorders; Severe Bipolar Disorder With Psychotic Features; Severe Major Depression With Psychotic Features	Behavioral: Family-aided Assertive Community Treatment; Behavioral: Enhanced standard treatment	N/A

Detailed Description

The proposed study will be part of a larger program, Portland Identification and Early Referral (PIER), under foundation, NIH and Center for Mental Health Services sponsorship, that has established a population-based system of early detection for Greater Portland, Maine. Previous and present effort has educated and trained the community-at-large and all health, education and other professionals, with the result that referrals are occurring at the expected frequency. The principal strategy is to intervene early, prior to onset, in the course of the onset of psychotic disorders to arrest the development of psychotic symptoms and functional disability. The test treatment is a specialized combination of psychoeducational multifamily group and assertive community treatment.

The project will support a team of clinical staff with the ability to: a. foster detection of prodromal disorders in the Greater Portland community by general practitioners, guidance counselors, mental health professionals and the general public; b. accurately assess individuals at high risk for psychosis; c. reliably deliver an evidence-based psychosocial and, if indicated, pharmacological treatment package using standardized methodology. The research study will test, in a randomized controlled trial, the symptomatic and functional outcome of treatment in 100 subjects ages 12 to 35 identified by that system. It will allow the analysis of key social factors contributing to psychosis and their interaction with the treatment conditions and each other.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Psychosis: Early Detection, Intervention and Prevention
• Study Start Date: May 1, 2003
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Family-aided Assertive Community Treatment The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	Behavioral: Family-aided Assertive Community Treatment; The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
Active Comparator: Enhanced standard treatment In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.	Behavioral: Enhanced standard treatment; In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention

Outcome Measures

Primary Outcome Measures

1. Onset of Psychosis [From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months]

   Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.

Secondary Outcome Measures

1. Functioning [24 months]

   Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Prodromal psychotic symptoms

• Age 12-35

• In catchment area (greater Portland, Maine)

Exclusion Criteria:

• Previous or current psychotic episode

• IQ less than 70

• Outside catchment area

• Toxic psychosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maine Medical Center	Portland	Maine	United States	04102

Sponsors and Collaborators

• MaineHealth
• Columbia University
• Harvard University
• University of California, Irvine

Investigators

• Principal Investigator: William R McFarlane, M.D., MaineHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

• McFarlane WR, Susser E, McCleary R, Verdi M, Lynch S, Williams D, McKeague IW. Reduction in incidence of hospitalizations for psychotic episodes through early identification and intervention. Psychiatr Serv. 2014 Oct;65(10):1194-200. doi: 10.1176/appi.ps.201300336.
• Woodberry KA, McFarlane WR, Giuliano AJ, Verdi MB, Cook WL, Faraone SV, Seidman LJ. Change in neuropsychological functioning over one year in youth at clinical high risk for psychosis. Schizophr Res. 2013 May;146(1-3):87-94. doi: 10.1016/j.schres.2013.01.017. Epub 2013 Feb 22.

• Responsible Party: William McFarlane, Principal Investigator, MaineHealth
• ClinicalTrials.gov Identifier: NCT01597141
• Other Study ID Numbers: 1R01MH065367-01A1
• First Posted: May 11, 2012
• Last Update Posted: Feb 8, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by William McFarlane, Principal Investigator, MaineHealth: Prodromal; Schizophrenia; Psychosis; Family psychoeducation; Assertive community treatment; Supported employment; Supported education
• Additional relevant MeSH terms: Disease; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders

Study Results

Participant Flow

Arm/Group Title	Family-aided ACT	Enhanced Treatment
Arm/Group Description	The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
Period Title: Overall Study
STARTED	50	50
COMPLETED	50	50
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Family-aided ACT	Enhanced Treatment	Total
Arm/Group Description	The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	16.48 (3.07)	16.12 (2.75)	16.3 (2.9)
Sex: Female, Male (Count of Participants)
Female	24 48%	24 48%	48 48%
Male	26 52%	26 52%	52 52%
Race/Ethnicity, Customized (participants) [Number]
Hispanic	0 0%	4 8%	4 4%
Non-Hispanic	50 100%	46 92%	96 96%
Region of Enrollment (participants) [Number]
United States	50 100%	50 100%	100 100%
Global Assessment of Functioning (GAF) (units on GAF scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on GAF scale]	40.16 (13.93)	36.39 (10.35)	39.7 (12.1)

Outcome Measures

1. Primary Outcome

Title	Onset of Psychosis
Description	Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.
Time Frame	From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Family-aided ACT	Enhanced Treatment
Arm/Group Description	The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
Measure Participants	50	50
Number [percentage of sample converting]	10	14

2. Secondary Outcome

Title	Functioning
Description	Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

15 participants in the FACT arm and 16 participants in the Enhanced Standard Treatment arm were not assessed, having discontinued participation in the study.

Arm/Group Title	Family-aided Assertive Community Treatment	Enhanced Standard Treatment
Arm/Group Description	The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication. Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.	In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention. Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
Measure Participants	35	34
Mean (Standard Deviation) [units on GAF scale]	59.83 (16.38)	54.68 (13.38)

Adverse Events

Arm/Group Title	Family-aided Assertive Community Treatment		Enhanced Standard Treatment
Arm/Group Description	The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.		In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
All Cause Mortality
	Family-aided Assertive Community Treatment		Enhanced Standard Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Family-aided Assertive Community Treatment		Enhanced Standard Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/50 (2%)		1/50 (2%)
Psychiatric disorders
Suicide	1/50 (2%)	1	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	Family-aided Assertive Community Treatment		Enhanced Standard Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

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.