A Preventive Behavioral Intervention for Young Adults With Psychotic Experiences
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorMassachusetts General Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Resilience Training (RT)
BehavioralRT 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)
BehavioralLST 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.
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: Resilience Training (RT)Experimental treatment 1 intervention
Group B: Life Skills Training (LST)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov