Resiliency Training on the College Campus

This is a waitlist controlled study examining the initial efficacy of Resilience Training among college students at an elevated risk for a severe mental illness.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Mood Disorders; Anxiety Disorders
• Intervention / Treatment: Behavioral: Resilience Training

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 18-30 years old
2. Enrolled in undergraduate program at the college or university where the intervention takes place
3. Students who endorse delusion-like experiences (DLEs): Peter's et al. Delusion Inventory (PDI) score > 4 and/or
4. Students with mild to moderate depressive symptoms: Beck Depression Inventory (BDI) score ≥ 6

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resilience Training; Participants obtained Resilience Training, a 4 session, 1.5 hour group intervention delivering the following skills: mindfulness, mentalization, and self-compassion.	Behavioral: Resilience Training; A 4 session group-based behavioral intervention which delivers the following skills: mindfulness, metallization, and self-compassion.
Placebo Comparator: Waitlist; A 4-6 week waitlist during which participants did not receive any treatment. They would then obtain Resilience Training following their waitlist period.	Behavioral: Resilience Training; A 4 session group-based behavioral intervention which delivers the following skills: mindfulness, metallization, and self-compassion.

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 to obtain 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). The PDI also captures conviction, preoccupation, and distress related to the delusions. This scale is scored from 0-21, with higher scores indicating more presence of these delusions.	Baseline, 4-weeks, 12 months
Beck Depression Inventory	The Beck Depression Inventory (BDI) is a 21-item self-report assessment obtaining ratings of one's level of depression on a Likert scale of 0-63, with higher scores indicating more depressive symptoms.	Baseline, 4-weeks, 12 months
Spielberger State-Trait Anxiety Inventory	The Spielberger State-Trait Anxiety Inventory (STAI) is a 20-item self-report scale obtaining ratings of one's anxiety, both those that are trait like and ongoing, and those that are state like and temporary. Scores range from 0-120, with higher scores indicate higher levels of anxiety symptoms.	Baseline, 4-weeks, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Connor-Davidson Resilience Scale	The Connor-Davidson Resilience Scale (CD-RISC) is a 25-item self-report scale obtaining ratings of one's level of coping and emotional resilience. It is rated on a scale of 0-100, with higher scores indicate one has more coping skills and more emotional resilience.	Baseline, 4-weeks, 12 months
Five Facet Mindfulness Questionnaire	The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report survey that obtains ratings of one's capacity for mindfulness. It contains 5 sub scales, although this study only used the total score. It is scored on a 0-195 scale, though a mean score is taken ranging from 0-5, with higher scores indicate greater capacity for mindfulness.	Baseline, 4-weeks, 12 months
Interpersonal Reactivity Index	The Interpersonal Reactivity Index (IRI) is a 28-item self-report scale that measures one's ability to experience empathy for another person. The scale has 4 sub scales, yet this study utilized only two of them: the empathic concern and perspective taking subscales. It is scored on a 0-140 scale, with higher ratings indicate more ability for empathy.	Baseline, 4-weeks, 12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Daphne Holt, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): November 26, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Anxiety Disorders; Mood Disorders
• Other Study ID Numbers: 2016P002351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to submit the full, yet de-identified dataset to Mendeley Data: https://data.mendeley.com at publication of this manuscript.
• 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