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InVEST Program for High Risk for Psychosis (InVEST Trial)

N/A
Recruiting
Led By Michelle Friedman-Yakoobian, PHD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 12-22
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 4 months and baseline to 8 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new intervention called InVEST for people at high risk for psychosis. The goal is to see if it can help with the specific difficulties that come with this phase. There will be an open trial with 8 participants first, to refine the intervention and make sure it is feasible and acceptable. Then there will be a randomized controlled trial with 30 participants, comparing InVEST to a delayed version of InVEST. The goal is to gain a preliminary understanding of the intervention's efficacy for the difficulties experienced by young people at CHR-P.

Who is the study for?
This trial is for English-speaking individuals aged 12-18 who are at high risk for psychosis, as determined by a specific interview process. They must have some difficulty with daily roles and their parent must agree to allow communication between the trial coaches and treatment providers.
What is being tested?
The InVEST program is being tested in two parts: an initial phase to assess feasibility and refine methods, followed by a randomized controlled trial comparing immediate InVEST intervention against delayed (DI) intervention to evaluate its effectiveness in improving role functioning.
What are the potential side effects?
Since InVEST involves educational and vocational support rather than medication, typical medical side effects are not expected. However, participants may experience stress or anxiety related to new challenges or changes in routine during the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 22 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 4 months and baseline to 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 4 months and baseline to 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of intervention -Client Satisfaction
Feasibility of intervention- drop out
Feasibility of intervention- recruitment rate
Secondary study objectives
Role functioning

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InVESTExperimental Treatment1 Intervention
4 month treatment condition
Group II: delayed investActive Control1 Intervention
participants in delayed invest wait four months and are reassessed before taking part in the intervention

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
861 Previous Clinical Trials
12,932,802 Total Patients Enrolled
24 Trials studying Schizophrenia
2,591 Patients Enrolled for Schizophrenia
Michelle Friedman-Yakoobian, PHDPrincipal InvestigatorDepartment of Psychiatry at BIDMC - a major teaching hospital of Harvard Medical School

Media Library

InVEST Clinical Trial Eligibility Overview. Trial Name: NCT05114733 — N/A
Schizophrenia Research Study Groups: delayed invest, InVEST
Schizophrenia Clinical Trial 2023: InVEST Highlights & Side Effects. Trial Name: NCT05114733 — N/A
InVEST 2023 Treatment Timeline for Medical Study. Trial Name: NCT05114733 — N/A
~3 spots leftby Jun 2025
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