Trial Outcomes & Findings for Specialized Treatment Early in Psychosis (STEP) (NCT NCT00309452)
NCT ID: NCT00309452
Last Updated: 2017-02-08
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
1 year after enrollment
Results posted on
2017-02-08
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Specialized Treatment Early in Psychosis (STEP)
Baseline characteristics by cohort
| Measure |
Treatment as Usual
n=57 Participants
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.
|
STEP Care
n=60 Participants
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.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.6 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
22.4 years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
22.5 years
STANDARD_DEVIATION 4.9 • n=206 Participants
|
|
Gender
Female
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Gender
Male
|
46 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Global Assessment of Functioning
|
34.42 units on a scale
STANDARD_DEVIATION 10.43 • n=99 Participants
|
36.22 units on a scale
STANDARD_DEVIATION 12.89 • n=107 Participants
|
35.88 units on a scale
STANDARD_DEVIATION 13.04 • n=206 Participants
|
|
PANNS Positive and Negative Symptom Scale
Positive Dimension
|
19.60 units on a scale
STANDARD_DEVIATION 5.90 • n=99 Participants
|
20.75 units on a scale
STANDARD_DEVIATION 6.74 • n=107 Participants
|
20.21 units on a scale
STANDARD_DEVIATION 6.36 • n=206 Participants
|
|
PANNS Positive and Negative Symptom Scale
Negative Dimension
|
17.01 units on a scale
STANDARD_DEVIATION 5.40 • n=99 Participants
|
17.82 units on a scale
STANDARD_DEVIATION 6.42 • n=107 Participants
|
17.44 units on a scale
STANDARD_DEVIATION 5.95 • n=206 Participants
|
|
PANNS Positive and Negative Symptom Scale
General Symptoms
|
33.70 units on a scale
STANDARD_DEVIATION 8.56 • n=99 Participants
|
33.42 units on a scale
STANDARD_DEVIATION 8.62 • n=107 Participants
|
33.56 units on a scale
STANDARD_DEVIATION 8.56 • n=206 Participants
|
|
PANNS Positive and Negative Symptom Scale
Total
|
70.33 units on a scale
STANDARD_DEVIATION 15.52 • n=99 Participants
|
72.0 units on a scale
STANDARD_DEVIATION 16.76 • n=107 Participants
|
71.21 units on a scale
STANDARD_DEVIATION 16.14 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 year after enrollmentOutcome measures
| Measure |
Treatment as Usual
n=57 Participants
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.
|
STEP Care
n=60 Participants
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.
|
|---|---|---|
|
Number of Patients Hospitalized
|
25 participants
|
14 participants
|
SECONDARY outcome
Timeframe: every 6 monthsData was not collected, instead Hospitalization (primary outcome) was used as a proxy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Treatment as Usual
n=57 Participants
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.
|
STEP Care
n=60 Participants
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.
|
|---|---|---|
|
Overall Functioning- Global Assessment of Functioning
Baseline
|
34.42 units on a scale
Standard Deviation 10.43
|
36.22 units on a scale
Standard Deviation 12.89
|
|
Overall Functioning- Global Assessment of Functioning
Change from baseline
|
20.38 units on a scale
Standard Deviation 16.61
|
22.22 units on a scale
Standard Deviation 15.46
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Treatment as Usual
n=57 Participants
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.
|
STEP Care
n=60 Participants
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.
|
|---|---|---|
|
Quality of Life- Heinrich's Quality of Life Scale
Baseline
|
59.45 units on a scale
Standard Deviation 18.02
|
59.87 units on a scale
Standard Deviation 22.25
|
|
Quality of Life- Heinrich's Quality of Life Scale
Change from Baseline
|
-.80 units on a scale
Standard Deviation 20.18
|
9.81 units on a scale
Standard Deviation 29.85
|
SECONDARY outcome
Timeframe: 1 year after enrollmentPopulation: 20 subjects from the treatment as usual arm were lost to follow-up. 12 subjects from STEP Care arm were lost to follow up.
Outcome measures
| Measure |
Treatment as Usual
n=37 Participants
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.
|
STEP Care
n=48 Participants
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.
|
|---|---|---|
|
Vocationally Engaged
|
26 participants
|
44 participants
|
SECONDARY outcome
Timeframe: every 6 monthsPopulation: Data was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Patients were lost to follow up. 15 subjects in the Treatment as Usual arm, and 15 subjects in the STEP care arm.
Number of participants in contact with mental health services. Collected via self-report.
Outcome measures
| Measure |
Treatment as Usual
n=42 Participants
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.
|
STEP Care
n=45 Participants
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.
|
|---|---|---|
|
Adherence- in Contact With Mental Health Services
|
33 participants
|
39 participants
|
SECONDARY outcome
Timeframe: every 6 monthsPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: This data was collected, numbers reflect actual data.
The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.
Outcome measures
| Measure |
Treatment as Usual
n=57 Participants
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.
|
STEP Care
n=60 Participants
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.
|
|---|---|---|
|
Subjects Who Committed Self-harm and Violence
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: every 6 monthsPopulation: data no collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 6 monthsTotal annual cost per patient
Outcome measures
| Measure |
Treatment as Usual
n=57 Participants
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.
|
STEP Care
n=60 Participants
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.
|
|---|---|---|
|
Economic Measures Including Service Use, Cost of Care and Forensic Data.
|
12157.46 dollars
Standard Error 2948.83
|
7625.22 dollars
Standard Error 2539.70
|
Adverse Events
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
STEP Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place