Preventive behavioral intervention for young adults with psychotic experiences
A Randomized Controlled Trial of a Preventive Behavioral Intervention for Young Adults With Psychotic Experiences
NA · Massachusetts General Hospital · NCT06929442
This study is testing if a new Resilience Training program can help college freshmen and sophomores who are at risk for serious mental illnesses feel better and prevent issues like psychosis, mood swings, and anxiety.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Charlestown, Massachusetts) |
| Trial ID | NCT06929442 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Resilience Training in college students who are at an elevated risk for developing serious mental illnesses. Participants, aged 18-30 and enrolled as freshmen or sophomores, will be randomly assigned to receive either Resilience Training or Life Skills Training. The study aims to assess how these interventions can help mitigate the onset of psychotic disorders, mood disorders, and anxiety disorders in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are college students aged 18-30 who have reported some psychotic experiences.
Not a fit: Patients currently experiencing active psychiatric symptoms or those receiving psychological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of developing serious mental illnesses among young adults.
How similar studies have performed: Other studies have shown promise in using resilience training for mental health prevention, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. 18-30 years old 2. Enrolled as a first or second year student (i.e., freshman or sophomore) in an undergraduate program at the college or university where the intervention takes place 3. Students who endorse some psychotic experiences (Peter's et al. Delusion Inventory (PDI) score \> 3) Exclusion criteria: 1. Inability to provide informed consent 2. Not proficient in English 3. Current self-reported Diagnostic Statistical Manual 5 (DSM-5) diagnosis with active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by clinical interview with participant, or self-report of a psychiatric diagnosis that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization 4. Current enrollment in psychological or behavioral health treatment. 5. Current use of psychotropic medications (other than stimulants) prescribed by a physician. 6. A diagnosis of a serious, chronic mental illness as determined by the Mini-International Neuropsychiatric Interview (MINI)
Where this trial is running
Charlestown, Massachusetts
- Massachusetts General Hospital — Charlestown, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Daphne J Holt, MD, PhD
- Email: dholt@mgh.harvard.edu
- Phone: 617-726-7618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Psychotic Disorders, Mood Disorders, Anxiety Disorders