Recruiting

Preventive Behavioral Intervention

Sponsor:

Massachusetts General Hospital

Code:

NCT06929442

Conditions

Psychotic Disorders

Mood Disorders

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Resilience Training (RT)

Life Skills Training (LST)

Study Details

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

Study ID

NCT06929442

Start date

Feb 10, 2025

Status verified date

May, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Resilience Training (RT)

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

active comparator: Life Skills Training (LST)

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.

Interventions

Resilience Training (RT)

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

Life Skills Training (LST)

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.

Primary outcome measure

  • Peters Delusions Inventory [ Time Frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months ]

Central Contacts and Locations

Central contacts

Daphne J Holt, MD, PhD

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

Locations

Massachusetts General Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Daphne J Holt, MD, PhD

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

Louis N Vinke, PhD

617-726-6043lvinke@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-11.