An interventional study of Resilience Training (RT) and Life Skills Training (LST) in Psychotic Disorders, Mood Disorders and Anxiety Disorders, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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.
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.
1,587 studies on the registry are indexed under Psychotic Disorders; 281 are open to participants now.
This study's planned enrollment of 192 is above the median of 65 across 1,320 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization.
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.
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.
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Plan to share: Yes — 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.
Supporting information: Clinical study report, Analytic code
Time frame: Study data will be come available once manuscripts are published.
Access criteria: Data shared will be coded, with no PHI included.
Data sharing details ↗ · nda.nih.gov
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Dec 2028, 45 months after the start.
Of 455 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 52. This study's planned 45 months is above that.
Counting every sponsor, half of 457 studies reached it within 34 months; a quarter within 19 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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