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A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences

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Mass General Brigham

Status

Enrolling

Conditions

Psychotic Disorders
Anxiety Disorders
Mood Disorders

Treatments

Behavioral: Life Skills Training (LST)
Behavioral: Resilience Training (RT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06929442
2016P0023511

Details and patient eligibility

About

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.

Enrollment

192 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

192 participants in 2 patient groups

Resilience Training (RT)
Experimental group
Description:
RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization.
Treatment:
Behavioral: Resilience Training (RT)
Life Skills Training (LST)
Active Comparator group
Description:
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.
Treatment:
Behavioral: Life Skills Training (LST)

Trial contacts and locations

1

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Central trial contact

Daphne J Holt, MD, PhD

Data sourced from clinicaltrials.gov

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