Clinical trial NCT06929442: A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences
Official title: A Randomized Controlled Trial of a Preventive Behavioral Intervention for Young Adults With Psychotic Experiences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Mood Disorders
Anxiety Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial with active control
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Peters Delusions Inventory
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Spielberger State-Trait Anxiety Inventory
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Columbia-Suicide Severity Rating Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: UCLA Loneliness Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Temporal Experience of Pleasure Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Anticipatory and Consummatory Interpersonal Pleasure Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Time Alone Questionnaire
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Social Discomfort Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Prodromal Questionnaire - Brief
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Phalen et al. Screener
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Launay-Slade Hallucination Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Structured Interview for Psychosis/Scale for the Assessment of Prodromal Symptoms
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Connor-Davidson Resilience Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Five Facet Mindfulness Questionnaire
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Self-Compassion Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Reflective Functioning Questionnaire
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Positive and Negative Affect Schedule
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: General Self-Efficacy Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Emotional Reactivity Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Difficulties in Emotion Regulation Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Perceived Stress Scale
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Emotion Recognition Task
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Emotion Differentiation Task
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Reading the Mind in the Eyes
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Stop Distance Paradigm
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
measure: Hippocampal-frontal functional connectivity
timeFrame: Baseline, 4-weeks, and 12 months
measure: Fear conditioning responses of the hippocampus
timeFrame: Baseline, 4-weeks, and 12 months
measure: Network-level functional connectivity
timeFrame: Baseline, 4-weeks, and 12 months
measure: Network-level functional activation during fear conditioning
timeFrame: Baseline, 4-weeks, and 12 months
measure: Looming network functional activation during fMRI looming paradigm
timeFrame: Baseline, 4-weeks, and 12 months
measure: Arterial Spin Labeling -measured perfusion of the hippocampus and other regions
timeFrame: Baseline, 4-weeks, and 12 months
measure: Neuromelanin-sensitive Magnetic Resonance Imaging in the midbrain
timeFrame: Baseline, 4-weeks, and 12 months
measure: Structural Connectivity: Diffusion Tensor Imaging
timeFrame: Baseline, 4-weeks, and 12 months
measure: Grade Point Average
timeFrame: Baseline, 12 months, and 24 months
measure: Registrar Enrollment Status Report
timeFrame: Baseline, 12 months, and 24 months
measure: Health Services Utilization
timeFrame: Baseline, 12 months, and 24 months
measure: Mini-International Neuropsychiatric Interview - DSM 5
timeFrame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: