Prodromal Schizophrenia, Psychotic Disorders, Severe Bipolar Disorder With Psychotic Features, Severe Major Depression With Psychotic Features
Conditions
Keywords
Prodromal, Schizophrenia, Psychosis, Family psychoeducation, Assertive community treatment, Supported employment, Supported education
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.
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.
Interventions
BEHAVIORALFamily-aided Assertive Community Treatment
The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
BEHAVIORALEnhanced standard treatment
In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
Sponsors
Columbia University
Harvard University
University of California, Irvine
MaineHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Family-aided ACT 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. | 50 |
| Enhanced Treatment 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 | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Family-aided ACT | Enhanced Treatment | Total |
|---|---|---|---|
| Age, Continuous | 16.48 years STANDARD_DEVIATION 3.07 | 16.12 years STANDARD_DEVIATION 2.75 | 16.3 years STANDARD_DEVIATION 2.9 |
| Global Assessment of Functioning (GAF) | 40.16 units on GAF scale STANDARD_DEVIATION 13.93 | 36.39 units on GAF scale STANDARD_DEVIATION 10.35 | 39.7 units on GAF scale STANDARD_DEVIATION 12.1 |
| Race/Ethnicity, Customized Hispanic | 0 participants | 4 participants | 4 participants |
| Race/Ethnicity, Customized Non-Hispanic | 50 participants | 46 participants | 96 participants |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 1 / 50 | 1 / 50 |
Outcome results
Primary
Onset of Psychosis
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Family-aided ACT | Onset of Psychosis | 10 percentage of sample converting |
| Enhanced Treatment | Onset of Psychosis | 14 percentage of sample converting |
Secondary
Functioning
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Family-aided ACT | Functioning | 59.83 units on GAF scale | Standard Deviation 16.38 |
| Enhanced Treatment | Functioning | 54.68 units on GAF scale | Standard Deviation 13.38 |