Psychotic DisordersNCT06929442
A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences
A study testing Resilience Training (RT) and Life Skills Training (LST) in people with Psychotic Disorders and Mood Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Psychotic Disorders, Mood Disorders, Anxiety Disorders
- What is being tested?
- Resilience Training (RT) and Life Skills Training (LST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
Daphne J Holt, MD, PhD, 617-726-7618, dholt@mgh.harvard.edu
Louis N Vinke, PhD, 617-726-6043, lvinke@mgh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychotic Disorders, Mood Disorders, Anxiety Disorders
- Being tested
- Resilience Training (RT), Life Skills Training (LST)
- Medical subject headings
- Psychotic Disorders, Mood Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience Training (RT)Behavioural
RT is a 4-week program of weekly 90-minute sessions in which participants are taught the following skills: mindfulness, self-compassion and mentalization.
Life Skills Training (LST)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resilience Training (RT) |
| 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. Receives: Behavioral: Life Skills Training (LST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Secondary outcomes (37)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start10 Feb 2025
- Primary completion1 Dec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial with active control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphne Holt, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929442
- Sponsor's protocol ID
- 2016P0023511
- Status last verified
- May 2026
- First submitted
- 4 Apr 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Preventive Behavioral Intervention for Young Adults With Psychotic Experiences
- ClinicalTrials.gov ID
- NCT06929442
- Acronym / sponsor ID
- 2016P0023511
- Conditions
- Psychotic Disorders, Mood Disorders, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial with active control
| Arm | Type | Receives |
|---|---|---|
| Resilience Training (RT) | Experimental | 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. |
| Life Skills Training (LST) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Resilience Training (RT) |
| 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. | Behavioural | Life Skills Training (LST) |
Primary outcome
Peters Delusions Inventory
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
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.
37 secondary outcomes
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
Connor-Davidson Resilience Scale
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Five Facet Mindfulness Questionnaire
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Self-Compassion Scale
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Reflective Functioning Questionnaire
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Positive and Negative Affect Schedule
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
General Self-Efficacy Scale
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Emotional Reactivity Scale
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Difficulties in Emotion Regulation Scale
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Perceived Stress Scale
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Emotion Recognition Task
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Emotion Differentiation Task
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Reading the Mind in the Eyes
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Stop Distance Paradigm
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Hippocampal-frontal functional connectivity
Time frame: Baseline, 4-weeks, and 12 months
Fear conditioning responses of the hippocampus
Time frame: Baseline, 4-weeks, and 12 months
Network-level functional connectivity
Time frame: Baseline, 4-weeks, and 12 months
Network-level functional activation during fear conditioning
Time frame: Baseline, 4-weeks, and 12 months
Looming network functional activation during fMRI looming paradigm
Time frame: Baseline, 4-weeks, and 12 months
Arterial Spin Labeling -measured perfusion of the hippocampus and other regions
Time frame: Baseline, 4-weeks, and 12 months
Neuromelanin-sensitive Magnetic Resonance Imaging in the midbrain
Time frame: Baseline, 4-weeks, and 12 months
Structural Connectivity: Diffusion Tensor Imaging
Time frame: Baseline, 4-weeks, and 12 months
Grade Point Average
Time frame: Baseline, 12 months, and 24 months
Registrar Enrollment Status Report
Time frame: Baseline, 12 months, and 24 months
Health Services Utilization
Time frame: Baseline, 12 months, and 24 months
Mini-International Neuropsychiatric Interview - DSM 5
Time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Training (RT) and Life Skills Training (LST) in people with Psychotic Disorders and Mood Disorders, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daphne J Holt, MD, PhD (617-726-7618, dholt@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peters Delusions Inventory (time frame: Baseline, 4-weeks, 6 month, 12 months, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.