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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resilience Training (RT) | Experimental | RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization. |
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| Life Skills Training (LST) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilience Training (RT) | Behavioral | RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daphne J Holt, MD, PhD | Contact | 617-726-7618 | dholt@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Charlestown | Massachusetts | 02129 | United States |
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.
Study data will be come available once manuscripts are published.
Data shared will be coded, with no PHI included.
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D019964 | Mood Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Randomized trial with active control
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| Life Skills Training (LST) | Behavioral | 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. |
|
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 |