A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences

NCT06929442 | Recruiting

• 1 other identifier: 2016P0023511
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial testing the efficacy of Resilience Training in college students with elevated transdiagnostic risk for developing a serious mental illness.

Conditions

Psychotic Disorders; Mood Disorders; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Peters Delusions Inventory

  The Peters Delusions Inventory (PDI) is a brief 21-item survey using non-stigmatizing and non-clinical language that obtains ratings of common delusional experiences (e.g. paranoia, grandiosity, ideas of reference) and perceptual aberrations (e.g. experiences of being controlled; thought insertion, withdrawal, and echoing), i.e., psychotic experiences. The PDI also measures conviction, preoccupation, and distress related to these experiences. This scale is scored from 0-21, with higher scores indicating a greater number of experiences endorsed.

  Baseline, 4-weeks, 6 month, 12 months, and 24 months

Secondary Outcomes (37)

• Beck Depression Inventory

  Baseline, 4-weeks, 6 month, 12 months, and 24 months

• Spielberger State-Trait Anxiety Inventory

  Baseline, 4-weeks, 6 month, 12 months, and 24 months

• Columbia-Suicide Severity Rating Scale

  Baseline, 4-weeks, 6 month, 12 months, and 24 months

• UCLA Loneliness Scale

  Baseline, 4-weeks, 6 month, 12 months, and 24 months

• Temporal Experience of Pleasure Scale

  Baseline, 4-weeks, 6 month, 12 months, and 24 months

Study Arms (2)

Resilience Training (RT)

EXPERIMENTAL

RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization.

Behavioral: Resilience Training (RT)

Life Skills Training (LST)

ACTIVE COMPARATOR

LST is a 4-week program of weekly 90-minute sessions, in which participants are provided information about helpful life skills, including financial literacy, health, physical and internet safety.

Behavioral: Life Skills Training (LST)

Interventions

Resilience Training (RT) BEHAVIORAL

RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization.

Resilience Training (RT)

Life Skills Training (LST) BEHAVIORAL

LST is a 4-week program of weekly 90-minute sessions, in which participants are provided information about helpful life skills, including financial literacy, health, physical and internet safety.

Life Skills Training (LST)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• 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
• Students who endorse some psychotic experiences (Peter's et al. Delusion Inventory (PDI) score \> 3)

You may not qualify if:

• Inability to provide informed consent
• Not proficient in English
• 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
• Current enrollment in psychological or behavioral health treatment.
• Current use of psychotropic medications (other than stimulants) prescribed by a physician.
• A diagnosis of a serious, chronic mental illness as determined by the Mini-International Neuropsychiatric Interview (MINI)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Mood Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Daphne J Holt, MD, PhD

CONTACT

617-726-7618; dholt@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized trial with active control

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 16, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: Study data will be come available once manuscripts are published.
• Access Criteria: Data shared will be coded, with no PHI included.

Locations

US (1)