Resiliency Training on the College Campus

Anxiety Disorders Clinical Trial

Official title:

Resiliency Training on the College Campus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06038786
• Other study ID #: 2016P002351
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 1, 2020
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Mood Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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