Back to resultsResiliency Training on the College Campus
Primary Purpose
Psychotic Disorders, Mood Disorders, Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resilience Training
Sponsored by
About this trial
This is an interventional prevention trial for Psychotic Disorders
Eligibility Criteria
Inclusion Criteria: 18-30 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 Exclusion Criteria: 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Resilience Training
Waitlist
Arm Description
Participants obtained Resilience Training, a 4 session, 1.5 hour group intervention delivering the following skills: mindfulness, mentalization, and self-compassion.
A 4-6 week waitlist during which participants did not receive any treatment. They would then obtain Resilience Training following their waitlist period.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT06038786
First Posted
August 28, 2023
Last Updated
September 14, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06038786
Brief Title
Resiliency Training on the College Campus
Official Title
Resiliency Training on the College Campus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Mood Disorders, Anxiety Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Waitlist controlled design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resilience Training
Arm Type
Experimental
Arm Description
Participants obtained Resilience Training, a 4 session, 1.5 hour group intervention delivering the following skills: mindfulness, mentalization, and self-compassion.
Arm Title
Waitlist
Arm Type
Placebo Comparator
Arm Description
A 4-6 week waitlist during which participants did not receive any treatment. They would then obtain Resilience Training following their waitlist period.
Intervention Type
Behavioral
Intervention Name(s)
Resilience Training
Intervention Description
A 4 session group-based behavioral intervention which delivers the following skills: mindfulness, metallization, and self-compassion.
Primary Outcome Measure Information:
Title
Peters Delusions Inventory
Description
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.
Time Frame
Baseline, 4-weeks, 12 months
Title
Beck Depression Inventory
Description
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.
Time Frame
Baseline, 4-weeks, 12 months
Title
Spielberger State-Trait Anxiety Inventory
Description
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.
Time Frame
Baseline, 4-weeks, 12 months
Secondary Outcome Measure Information:
Title
Connor-Davidson Resilience Scale
Description
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.
Time Frame
Baseline, 4-weeks, 12 months
Title
Five Facet Mindfulness Questionnaire
Description
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.
Time Frame
Baseline, 4-weeks, 12 months
Title
Interpersonal Reactivity Index
Description
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.
Time Frame
Baseline, 4-weeks, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-30 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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daphne Holt, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
http://data.mendeley.com
Learn more about this trial
Resiliency Training on the College Campus
We'll reach out to this number within 24 hrs