Clinical trial NCT04338256: Mental Health Curriculum Study
Official title: Wellness and Resilience for College and Beyond: A Quasi-Experimental Pilot Study Investigating a Dialectical Behavior Therapy Skills-Infused College Course
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Issue
Keywords: Mental Health Education
Public Health
Dialectical Behavior Therapy
College Students
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Citrone 33 Foundation
First posted: 2020-04-08
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is undergraduate college students recruited from five college campuses in Pennsylvania and West Virginia.

Brief summary: The purpose of this study is to investigate the acceptability, appropriateness, feasibility, and preliminary effectiveness of a college course grounded in skills from dialectical behavior therapy (DBT) titled, "Wellness and Resilience for College and Beyond." The study takes place on 5 college campuses in Pennsylvania and West Virginia offering the Wellness Course during the 2020 calendar year (Spring and Fall 2020 semesters). The Wellness Course is an undergraduate college course that includes 14 two and a half hour long lessons, weekly homework assignments and tracking of skills use via a "diary card," and a cumulative final exam at the end of the semester. Students who choose to enroll in the wellness course are offered the opportunity to enroll in the study and a comparison sample of students not enrolled are recruited from each site.


Eligibility criteria: Inclusion Criteria:

* Undergraduate College Students
* Enrolled at one of the five study sites

Exclusion Criteria:

* Students who are not undergraduates
* Students who do not fall within the age limits for the study (age 18-24 year)
* Students who are not enrolled at one of the five study sites

Primary outcomes:
measure: Acceptability of the Wellness Course: Acceptability of Intervention Measure (AIM)
timeFrame: End of semester timepoint (approximately 4 months after baseline)
measure: Appropriateness of the Wellness Course: Intervention Appropriateness Measure (IAM)
timeFrame: End of semester timepoint (approximately 4 months after baseline)
measure: Feasibility of the Wellness Course: Feasibility of Intervention Measure (FIM)
timeFrame: End of semester timepoint (approximately 4 months after baseline)
Secondary outcomes:
measure: Change in Use of Adaptive Coping Skills from Baseline to End of Semester (approximately 4 months after baseline)
timeFrame: Baseline and end of semester (approximately 4 months after baseline)
measure: Change in Use of Adaptive Coping Skills from End of Semester (approximately 4 months after baseline) to 3-Month Follow-up
timeFrame: End of semester (approximately 4 months after baseline) and 3-month follow-up
measure: Change in Use of Adaptive Coping Skills from Baseline to 3-Month Follow-up
timeFrame: Baseline and 3-month follow-up
measure: Change in Emotion Dysregulation from Baseline to End of Semester (approximately 4 months after baseline)
timeFrame: Baseline and end of semester (approximately 4 months after baseline)
measure: Change in Emotion Dysregulation from End of Semester to 3-month follow-up
timeFrame: End of semester (approximately 4 months after baseline) and 3-month follow-up
measure: Change in Emotion Dysregulation from Baseline to 3-month follow-up
timeFrame: Baseline and 3-month follow-up
measure: Percent of Subjects with Past-30 Day Suicide Ideation at Baseline
timeFrame: Baseline
measure: Percent of Subjects with Past-30 Day Suicide Ideation at End of Semester (approximately 4 months after baseline)
timeFrame: End of semester (approximately 4 months after baseline)
measure: Percent of Subjects with Past-30 Day Suicide Ideation at 3-month follow-up
timeFrame: 3-month follow-up
measure: Change in Past-30 Day Suicide Risk from Baseline to End of Semester (approximately 4 months after baseline)
timeFrame: Baseline and end of semester (approximately 4 months after baseline)
measure: Change in Past-30 Day Suicide Risk from End of Semester (approximately 4 months after baseline) to 3-month follow-up
timeFrame: End of semester (approximately 4 months after baseline) and 3-month follow-up
measure: Change in Past-30 Day Suicide Risk from Baseline to 3-month follow-up
timeFrame: Baseline and 3-month follow-up
Other outcomes:
Locations:
city: Greensburg
country: United States
facility: University of Pittsburgh, Greensburg Campus
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Carlow University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Pittsburgh
name: Carla D Chugani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chugani CD, Fuhrman B, Abebe KZ, Talis J, Miller E, Coulter RWS. Wellness and resilience for college and beyond: protocol for a quasi-experimental pilot study investigating a dialectical behaviour therapy skill-infused college course. BMJ Open. 2020 Jun 21;10(6):e036833. doi: 10.1136/bmjopen-2020-036833.