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Completed

NCT Number: NCT06038786

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.

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Key information

Conditions

Psychotic Disorders Anxiety Disorders Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resilience Training

Behavioral

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

Primary outcomes

  1. Peters Delusions Inventory

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Connor-Davidson Resilience Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 15, 2023
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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