A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences

NCT ID: NCT06929442

Last Updated: 2025-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Psychotic Disorders Mood Disorders Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized trial with active control
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Resilience Training (RT)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Life Skills Training (LST)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daphne Holt

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daphne J Holt, MD, PhD

Role: CONTACT

617-726-7618

Facility Contacts

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Daphne J Holt, MD, PhD

Role: primary

617-726-7618

Louis N Vinke, PhD

Role: backup

617-726-6043

Other Identifiers

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2016P0023511

Identifier Type: -

Identifier Source: org_study_id

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