Schizophrenia and Disorders With Psychotic Features
Conditions
Keywords
First episode psychosis, Specialized care, Phase-specific treatment, Schizophrenia, Disorders with psychotic features
Brief summary
The purpose of this study is to understand the effectiveness of a specialized package of phase-specific treatments for individuals in the midst of their first episode of psychosis. The pharmacologic and psychosocial treatments will be delivered within a state public mental health center.
Detailed description
We propose to conduct a clinical trial for first episode psychosis patients not eligible for CMHC services that will compare randomized access to care at CMHC versus the usual procedure of referral to community providers outside CMHC. Patients randomized to access to CMHC services will receive multifaceted, intensive, phase-specific care delivered by a specialized clinical team. This care will include five principal components: antipsychotic prescription, multi-family group therapy, group cognitive behavioral therapy, cognitive remediation and individual case management including supportive, problem solving approaches and a focus on resumption of movement towards educational and/or employment related goals. All consenting subjects will undergo research evaluations every six months for up to five years. Outcomes will be assessed in the domains of re-admission (primary outcome), relapse, symptoms, overall functioning, quality of life, education and employment, treatment satisfaction, adherence, substance use, adverse events (including self-harm) and economic measures including service use, cost of care and forensic data.
Interventions
BEHAVIORALCognitive Behavioral Group Therapy
once per week
BEHAVIORALCognitive remediation
as needed
DRUGMedications
Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
BEHAVIORALMFG
Multi-Family psychoeducation Group based on the model published by McFarlane et al.
BEHAVIORALAssertive case management
Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.
OTHERTreatment as Usual in the community
Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Age 16-45 2. Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the SCID 3. ≤8 weeks of received antipsychotic treatment lifetime at time of referral 4. Willing to be treated in New Haven
Exclusion criteria
1. Psychosis believed due to substance use (based on the SCID) 2. Unable or unwilling to give informed consent 3. MR as indicated by receipt of services from Dept of Mental Retardation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Hospitalized | 1 year after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Functioning- Global Assessment of Functioning | 12 months | The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning. The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning. |
| Quality of Life- Heinrich's Quality of Life Scale | 12 months | The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126. The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health. |
| Vocationally Engaged | 1 year after enrollment | — |
| Treatment Satisfaction | every 6 months | — |
| Relapse | every 6 months | Data was not collected, instead Hospitalization (primary outcome) was used as a proxy |
| Substance Use | every 6 months | — |
| Subjects Who Committed Self-harm and Violence | 12 months | The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months. |
| Medication (Including Metabolic) Side Effects | every 6 months | — |
| Economic Measures Including Service Use, Cost of Care and Forensic Data. | every 6 months | Total annual cost per patient |
| Adherence- in Contact With Mental Health Services | 1 year | Number of participants in contact with mental health services. Collected via self-report. |
Countries
United States
Participant flow
Pre-assignment details
There were 512 requests for information, of which 491 were screened by phone for eligibility. 284 were excluded. Of the 207 who completed a full in-person eligibility assessment, 2 were deemed ineligible and 29 were provided STEP care without randomization in an initial pilot (data not included). 120 of the remaining 176 patients were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual Referral to community providers.
Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic. | 57 |
| STEP Care Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
Cognitive Behavioral Group Therapy: once per week
Cognitive remediation: as needed
Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports. | 60 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Treatment as Usual | STEP Care | Total |
|---|---|---|---|
| Age, Continuous | 22.6 years STANDARD_DEVIATION 5.3 | 22.4 years STANDARD_DEVIATION 4.5 | 22.5 years STANDARD_DEVIATION 4.9 |
| Gender Female | 11 Participants | 11 Participants | 22 Participants |
| Gender Male | 46 Participants | 49 Participants | 95 Participants |
| Global Assessment of Functioning | 34.42 units on a scale STANDARD_DEVIATION 10.43 | 36.22 units on a scale STANDARD_DEVIATION 12.89 | 35.88 units on a scale STANDARD_DEVIATION 13.04 |
| PANNS Positive and Negative Symptom Scale General Symptoms | 33.70 units on a scale STANDARD_DEVIATION 8.56 | 33.42 units on a scale STANDARD_DEVIATION 8.62 | 33.56 units on a scale STANDARD_DEVIATION 8.56 |
| PANNS Positive and Negative Symptom Scale Negative Dimension | 17.01 units on a scale STANDARD_DEVIATION 5.4 | 17.82 units on a scale STANDARD_DEVIATION 6.42 | 17.44 units on a scale STANDARD_DEVIATION 5.95 |
| PANNS Positive and Negative Symptom Scale Positive Dimension | 19.60 units on a scale STANDARD_DEVIATION 5.9 | 20.75 units on a scale STANDARD_DEVIATION 6.74 | 20.21 units on a scale STANDARD_DEVIATION 6.36 |
| PANNS Positive and Negative Symptom Scale Total | 70.33 units on a scale STANDARD_DEVIATION 15.52 | 72.0 units on a scale STANDARD_DEVIATION 16.76 | 71.21 units on a scale STANDARD_DEVIATION 16.14 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 57 | 0 / 60 |
| serious Total, serious adverse events | 0 / 57 | 0 / 60 |
Outcome results
Primary
Number of Patients Hospitalized
Time frame: 1 year after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Number of Patients Hospitalized | 25 participants |
| STEP Care | Number of Patients Hospitalized | 14 participants |
Comparison: Between groups comparison for hospitalization rates, adjusted for pretreatment hospitalizationp-value: 0.018Chi-squared, Corrected
Secondary
Adherence- in Contact With Mental Health Services
Number of participants in contact with mental health services. Collected via self-report.
Time frame: 1 year
Population: Patients were lost to follow up. 15 subjects in the Treatment as Usual arm, and 15 subjects in the STEP care arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Adherence- in Contact With Mental Health Services | 33 participants |
| STEP Care | Adherence- in Contact With Mental Health Services | 39 participants |
Secondary
Economic Measures Including Service Use, Cost of Care and Forensic Data.
Total annual cost per patient
Time frame: every 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Economic Measures Including Service Use, Cost of Care and Forensic Data. | 12157.46 dollars | Standard Error 2948.83 |
| STEP Care | Economic Measures Including Service Use, Cost of Care and Forensic Data. | 7625.22 dollars | Standard Error 2539.7 |
Secondary
Medication (Including Metabolic) Side Effects
Time frame: every 6 months
Population: data no collected
Secondary
Overall Functioning- Global Assessment of Functioning
The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning. The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Overall Functioning- Global Assessment of Functioning | Baseline | 34.42 units on a scale | Standard Deviation 10.43 |
| Treatment as Usual | Overall Functioning- Global Assessment of Functioning | Change from baseline | 20.38 units on a scale | Standard Deviation 16.61 |
| STEP Care | Overall Functioning- Global Assessment of Functioning | Baseline | 36.22 units on a scale | Standard Deviation 12.89 |
| STEP Care | Overall Functioning- Global Assessment of Functioning | Change from baseline | 22.22 units on a scale | Standard Deviation 15.46 |
Secondary
Quality of Life- Heinrich's Quality of Life Scale
The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126. The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Quality of Life- Heinrich's Quality of Life Scale | Baseline | 59.45 units on a scale | Standard Deviation 18.02 |
| Treatment as Usual | Quality of Life- Heinrich's Quality of Life Scale | Change from Baseline | -.80 units on a scale | Standard Deviation 20.18 |
| STEP Care | Quality of Life- Heinrich's Quality of Life Scale | Baseline | 59.87 units on a scale | Standard Deviation 22.25 |
| STEP Care | Quality of Life- Heinrich's Quality of Life Scale | Change from Baseline | 9.81 units on a scale | Standard Deviation 29.85 |
Secondary
Relapse
Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
Time frame: every 6 months
Secondary
Subjects Who Committed Self-harm and Violence
The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.
Time frame: 12 months
Population: This data was collected, numbers reflect actual data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Subjects Who Committed Self-harm and Violence | 0 participants |
| STEP Care | Subjects Who Committed Self-harm and Violence | 0 participants |
Secondary
Substance Use
Time frame: every 6 months
Population: This was not a planned primary or secondary outcome in our analysis (though collected at baseline) and because of significant attrition we did not report on this outcome despite having phone call f/u data on other outcomes. We did not believe phone reports on this outcome would produce reliable data.
Secondary
Treatment Satisfaction
Time frame: every 6 months
Population: Data was not collected
Secondary
Vocationally Engaged
Time frame: 1 year after enrollment
Population: 20 subjects from the treatment as usual arm were lost to follow-up. 12 subjects from STEP Care arm were lost to follow up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment as Usual | Vocationally Engaged | 26 participants |
| STEP Care | Vocationally Engaged | 44 participants |
Comparison: Between groups comparison for vocational engagement, adjusted for pretreatment vocational engagementp-value: 0.002Chi-squared, Corrected