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Recruiting NCT06929442

A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences

No phase Interventional Psychotic Disorders Mood Disorders Anxiety Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Resilience Training (RT), Life Skills Training (LST).
Who it may be relevant to
Registry conditions: Psychotic Disorders, Mood Disorders, Anxiety Disorders. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Trial of a Preventive Behavioral Intervention for Young Adults With Psychotic Experiences

Overview

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

This is a definitive, randomized controlled trial that will measure the efficacy of Resilience Training, a four-session group-based behavioral intervention conducted in transdiagnostically at-risk young adults who have psychotic experiences. The primary goal is to determine whether Resilience Training is superior to a time-matched active control condition, Life Skills Training, in reducing transdiagnostic symptoms of psychopathology, such as psychotic experiences, and improving long-term psychiatric (preventing the onset of psychiatric diagnoses) and functional (improving academic performance and retention in college) outcomes in this at-risk population. In addition, a proposed model of the mechanisms of action of RT, involving reducing emotion reactivity and changes in hippocampal function and connectivity, will be assessed.

Interventions

  • Behavioral 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.
  • 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.

Primary outcome measures

  • Peters Delusions Inventory [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
Secondary outcome measures (12)
  • Beck Depression Inventory [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Spielberger State-Trait Anxiety Inventory [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Columbia-Suicide Severity Rating Scale [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • UCLA Loneliness Scale [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Temporal Experience of Pleasure Scale [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Anticipatory and Consummatory Interpersonal Pleasure Scale [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Time Alone Questionnaire [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Social Discomfort Scale [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Prodromal Questionnaire - Brief [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Phalen et al. Screener [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Launay-Slade Hallucination Scale [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]
  • Structured Interview for Psychosis/Scale for the Assessment of Prodromal Symptoms [Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months]

Eligibility criteria

Inclusion criteria

  • 18-30 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)

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Massachusetts General Hospital — Charlestown

Identifiers

NCT: NCT06929442 · 2016P0023511

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗