Resiliency Training on the College Campus

NCT06038786 | Completed

• 1 other identifier: 2016P002351
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychotic Disorders; Mood Disorders; Anxiety Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Connor-Davidson Resilience Scale

  Baseline, 4-weeks, 12 months

• Five Facet Mindfulness Questionnaire

  Baseline, 4-weeks, 12 months

• Interpersonal Reactivity Index

  Baseline, 4-weeks, 12 months

Study Arms (2)

Resilience Training

EXPERIMENTAL

Participants obtained Resilience Training, a 4 session, 1.5 hour group intervention delivering the following skills: mindfulness, mentalization, and self-compassion.

Behavioral: Resilience Training

Waitlist

PLACEBO COMPARATOR

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

Interventions

Resilience Training BEHAVIORAL

A 4 session group-based behavioral intervention which delivers the following skills: mindfulness, metallization, and self-compassion.

Resilience Training; Waitlist

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (1)

• DeTore NR, Burke A, Nyer M, Holt DJ. A Brief Resilience-Enhancing Intervention and Loneliness in At-Risk Young Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2354728. doi: 10.1001/jamanetworkopen.2023.54728.

  PMID: 38315488 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Mood Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Daphne Holt, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Waitlist controlled design

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 15, 2023
• Study Start: July 1, 2018
• Primary Completion: November 26, 2019
• Study Completion: March 1, 2020
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, 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.

Locations

US (1)