Resiliency Training on the College Campus

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06038786
Collaborator
(none)
107
1
2
20
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Resilience Training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Waitlist controlled designWaitlist controlled design
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Resiliency Training on the College Campus
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Nov 26, 2019
Actual Study Completion Date :
Mar 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Peters Delusions Inventory [Baseline, 4-weeks, 12 months]

    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.

  2. Beck Depression Inventory [Baseline, 4-weeks, 12 months]

    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.

  3. Spielberger State-Trait Anxiety Inventory [Baseline, 4-weeks, 12 months]

    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.

Secondary Outcome Measures

  1. Connor-Davidson Resilience Scale [Baseline, 4-weeks, 12 months]

    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.

  2. Five Facet Mindfulness Questionnaire [Baseline, 4-weeks, 12 months]

    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.

  3. Interpersonal Reactivity Index [Baseline, 4-weeks, 12 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Charlestown Massachusetts United States 02129

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daphne Holt, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT06038786
Other Study ID Numbers:
  • 2016P002351
First Posted:
Sep 15, 2023
Last Update Posted:
Sep 15, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2023