A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders; Mood Disorders; Anxiety Disorders
• Intervention / Treatment: Behavioral: Resilience Training (RT); Behavioral: Life Skills Training (LST)

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.

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daphne J Holt, MD, PhD; Phone Number: 617-726-7618; Email: dholt@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Daphne J Holt, MD, PhD; Phone Number: 617-726-7618; Email: dholt@mgh.harvard.edu
      • Contact: Louis N Vinke, PhD; Phone Number: 617-726-6043; Email: lvinke@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peters Delusions Inventory	The Peters Delusions Inventory (PDI) is a brief 21-item survey using non-stigmatizing and non-clinical language that obtains ratings of common delusional experiences (e.g. paranoia, grandiosity, ideas of reference) and perceptual aberrations (e.g. experiences of being controlled; thought insertion, withdrawal, and echoing), i.e., psychotic experiences. The PDI also measures conviction, preoccupation, and distress related to these experiences. This scale is scored from 0-21, with higher scores indicating a greater number of experiences endorsed.	Baseline, 4-weeks, 6 month, 12 months, and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory	The Beck Depression Inventory (BDI) is a 21-item self-report assessment of symptoms of depression on a Likert scale of 0-63, with higher scores indicating more depressive symptoms.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Spielberger State-Trait Anxiety Inventory	The Spielberger State-Trait Anxiety Inventory (STAI) is a 20-item self-report scale measuring symptoms of anxiety, both those that are trait-like and ongoing, and those that are state-like and current. Scores range from 0-120, with higher scores indicate higher levels of anxiety symptoms.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Columbia-Suicide Severity Rating Scale	The Columbia-Suicide Severity Rating Scale (C-SSRS) is an interview-based measure to identify and assess suicidal thoughts, behaviors and suicide risk. The interview consists of two subscales, an ideation and behavior subscale. The severity of ideation subscale is rated on a 5-point ordinal scale, with higher scores indicating a more detailed plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
UCLA Loneliness Scale	The UCLA Loneliness Scale is a 20-item scale to measure subjective feelings associated with loneliness. Scores range from 20 - 80, with higher scores indicating stronger degree of loneliness reported.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Temporal Experience of Pleasure Scale	The Temporal Experience of Pleasure Scale (TEPS) is an 18-item questionnaire used to assess experiences of both anticipatory and consummatory aspects of pleasure. The Anticipatory score ranges from 10 - 60, with higher scores indicating greater pleasure. The Consummatory score ranges from 8 - 48, with higher scores indicating greater pleasure.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Anticipatory and Consummatory Interpersonal Pleasure Scale	The Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) is a 17-item measure of both anticipatory and consummatory social pleasure. Scores range from 17 - 102, with lower equals indicating greater social anhedonia. The Anticipatory scale is scored between 10 - 60, wither higher scores indicating more pleasure. The Consummatory scale is scored from 7 - 42, with higher scores indicating more pleasure.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Time Alone Questionnaire	The Time Alone Questionnaire (TAQ) is a 6-item questionnaire used to assess the portion of waking hours spent with others, compared to the desired amount of time spent with others. Participants are asked to estimate the average percentage of their waking hours actually spent with other people versus alone (ranging from 0 - 1), and the percentage of their waking hours that they would prefer to spend with other people versus alone (ranging from 0 - 1).	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Social Discomfort Scale	The Social Discomfort Scale (SDS) is a 3-item questionnaire assessing to what extent - and reason for why - individuals are uncomfortable in the physical presence of others. Scores range from 1 - 6, with higher scores indicating higher levels of social discomfort.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Prodromal Questionnaire - Brief	The Prodromal Questionnaire - Brief (PQ-B) is a 9-item scale designed to assess subclinical symptoms of psychosis. Scores range from 0 - 21, with higher scores indicating more severe symptoms reported.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Phalen et al. Screener	The Phalen et al. Screener is a 4-item questionnaire used to assess subclinical psychotic symptoms (psychotic experiences). Scores range from 0 - 4, with higher scores indicating the presence of more psychotic symptoms.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Launay-Slade Hallucination Scale	The Launay-Slade Hallucination Scale (LSHS) is a 16-item questionnaire used to assess hallucinatory experiences. Scores range from 0 - 64, with higher scores indicating greater frequency of hallucinations reported.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Structured Interview for Psychosis/Scale for the Assessment of Prodromal Symptoms	The Structured Interview for Psychosis/Scale for the Assessment of Prodromal Symptoms (SIPS/SOPS) is a measure of subclinical symptoms of psychosis. It is organized into four primary symptom sections, with a total of 19 items each rated on a scale from 0-6, with higher scores indicating higher symptom severity.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Connor-Davidson Resilience Scale	The Connor-Davidson Resilience Scale (CD-RISC) is a 25-item self-report scale assessing levels of coping and emotional resilience. It is rated on a scale of 0-100, with higher scores indicating greater coping skills and emotional resilience.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Five Facet Mindfulness Questionnaire	The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report survey assessing one's capacity for mindfulness. It contains 5 sub-scales. It is scored on a 0-195 scale, with higher scores indicating a greater capacity for mindfulness.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Self-Compassion Scale	The Self-Compassion Scale (SCS) a 26-item scale for the assessment of self-compassion. Scores range from 16 - 80, with higher scores indicating better self-compassion reported.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Reflective Functioning Questionnaire	Reflective Functioning Questionnaire (RFQ) is a 31-item questionnaire to assess impairments in mentalization. Scores range from 31 - 217, with higher scores indicating better reflective functioning reported.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Positive and Negative Affect Schedule	The Positive and Negative Affect Schedule (PANAS) is a 20-item questionnaire for assessing positive and negative affect. It is organized into two primary sections, each section with 10 items, ranging from 1 - 5, with higher scores indicating stronger affect.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
General Self-Efficacy Scale	The General Self-Efficacy Scale (GSE), is a 10-item questionnaire for the assessment of self-efficacy, the ability to cope with stressors. Scores range from 10 - 40, with higher scores indicating stronger self-efficacy reported.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Emotional Reactivity Scale	The Emotional Reactivity Scale (ERS) is a 21-item self-report measure of emotional reactivity, comprised of emotion sensitivity, intensity, and persistence. Scores range from 0 - 44, with higher scores indicating greater emotional reactivity.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Difficulties in Emotion Regulation Scale	The Difficulties in Emotion Regulation Scale (DERS) is a 36-item questionnaire to assess how people regulate their emotions. Scores range from 36 - 180, with higher scores indicating greater impairment and difficulties in regulating emotions.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Perceived Stress Scale	The Perceived Stress Scale (PSS) is a 10-item, widely-used psychological instrument for measuring the perception of stress. Scores range from 0 - 40, with higher scores indicating greater perceived stress.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Emotion Recognition Task	The Emotion Recognition Task (ER40) assesses facial emotion recognition ability and includes 40 color photographs of faces. Recognition task accuracy percentage ranges from 0 - 1 (average over all 40 trials).	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Emotion Differentiation Task	The Emotion Differentiation Task is a task with 36 face pairs (13 happy, 13 sad) measuring the ability to detect subtle differences in intensity within emotions. Differentiation task accuracy percentage ranges from 0 - 1 (average over all 36 trials).	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Reading the Mind in the Eyes	Reading the Mind in the Eyes is an objective measure of Theory-of-Mind capacity, particularly the ability to read emotion.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Stop Distance Paradigm	The Stop Distance Paradigm is an objective measure for assessing the size and permeability of personal space.	Baseline, 4-weeks, 6 month, 12 months, and 24 months
Hippocampal-frontal functional connectivity	The hippocampal-frontal functional connectivity measure is derived from functional magnetic resonance imaging (fMRI) data acquired during a 10 minute period when the participant is in a state of wakefulness but has no directed task. In the analyses, fluctuations in hippocampal activity during this period are correlated with activity fluctuations of frontal cortical regions to produce a measure of connectivity strength.	Baseline, 4-weeks, and 12 months
Fear conditioning responses of the hippocampus	This measure is derived from fMRI data acquired when the participant is presented with faces, some of which have been associated with an aversive stimulus. In the analysis, hippocampal activation during blocks of non-aversive and aversive stimulus presentations are directly contrasted to produce a measure of fear conditioning activation.	Baseline, 4-weeks, and 12 months
Network-level functional connectivity	The functional connectivity measure is derived from fMRI data acquired during a 10 minute period when the participant is in a state of wakefulness but has no directed task. In the analyses, fluctuations in activity within the Salience, Default Mode, and Looming networks throughout this period are correlated against other networks and regions to produce a measure of connectivity strength.	Baseline, 4-weeks, and 12 months
Network-level functional activation during fear conditioning	Neural responses during fear conditioning are derived from fMRI data acquired when the participant is presented with faces, some of which have been associated with an aversive stimulus. In the analyses, activation within the Salience, Default Mode, and Looming networks during blocks of non-aversive and aversive stimulus presentations are directly contrasted to produce a measure of fear conditioning activation.	Baseline, 4-weeks, and 12 months
Looming network functional activation during fMRI looming paradigm	Neural responses to looming stimuli are derived from fMRI data acquired when the participant is presented with faces which appear to move towards (approach) or away (withdraw) from the participant. In the analyses, Looming network activation during blocks of approaching face and withdrawing face presentations are directly contrasted to produce a measure of looming activation.	Baseline, 4-weeks, and 12 months
Arterial Spin Labeling -measured perfusion of the hippocampus and other regions	Arterial Spin Labeling (ASL) fMRI data are acquired to assess cerebral blood flow (perfusion) within the hippocampus and other subcortical and cortical regions.	Baseline, 4-weeks, and 12 months
Neuromelanin-sensitive Magnetic Resonance Imaging in the midbrain	Neuromelanin-sensitive Magnetic Resonance Imaging (NM-MRI) is a brain MRI technique capable of measuring MR signal intensity associated with neuromelanin (NM), a by-product of dopamine turnover, concentrated in the catecholamine-containing areas of the midbrain.	Baseline, 4-weeks, and 12 months
Structural Connectivity: Diffusion Tensor Imaging	Diffusion Tensor Imaging (DTI) neuroimaging data are acquired to assess the structural connectivity between and within brain areas using the following metrics: Mean Diffusivity (MD), Axial Diffusivity (AD), Fractional anisotropy (FA), and Radial Diffusivity (RD).	Baseline, 4-weeks, and 12 months
Grade Point Average	Each participant's grade point average (GPA) will be obtained from the academic registrar for each semester, as well as the cumulative GPA.	Baseline, 12 months, and 24 months
Registrar Enrollment Status Report	The registrar enrollment status report will be obtained from the academic registrar, including records of any leaves of absence or withdrawals from college. The report will consist of categorical data indicating enrollment status as either: full-time (full course load), part-time (half course load), graduated, withdrawn (dropped out), or on leave (medical).	Baseline, 12 months, and 24 months
Health Services Utilization	Health services utilization history will be obtained from the student health center reporting the frequency of on-campus behavioral health visits.	Baseline, 12 months, and 24 months
Mini-International Neuropsychiatric Interview - DSM 5	The Mini-International Neuropsychiatric Interview (MINI) - DSM 5 is a structured diagnostic interview to assess psychiatric diagnoses.	Baseline, 4-weeks, 6 month, 12 months, and 24 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Psychotic Disorders; Anxiety Disorders; Mood Disorders
• Other Study ID Numbers: 2016P0023511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators are sharing the data collected in this project via a two-tiered process via the NIMH Data Archive (http://nda.nih.gov/, NDA). The first tier is for the submission of descriptive/raw data while the study is ongoing. The second tier is for the submission of analyzed data at the time of the publication of results or when the study's primary aims have been achieved.
• IPD Sharing Time Frame: Study data will be come available once manuscripts are published.
• IPD Sharing Access Criteria: Data shared will be coded, with no PHI included.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No