Mental Health Curriculum Study

Wellness and Resilience for College and Beyond: A Quasi-Experimental Pilot Study Investigating a Dialectical Behavior Therapy Skills-Infused College Course

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Behavioral: Wellness and Resilience for College and Beyond (Undergraduate College Course)

• Study Type: Observational
• Enrollment (Actual): 295

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Greensburg, Pennsylvania, United States, 15601
      • University of Pittsburgh, Greensburg Campus
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15213
      • Carnegie Mellon University
    • Pittsburgh, Pennsylvania, United States, 15213
      • Carlow University
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is undergraduate college students recruited from five college campuses in Pennsylvania and West Virginia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Students enrolled in the Wellness Course; Students in this group are enrolled in the Wellness Course for the Spring 2020 or Fall 2020 semesters	Behavioral: Wellness and Resilience for College and Beyond (Undergraduate College Course); The course, "Wellness and Resilience for College and Beyond" was originally developed by James Mazza, PhD and colleagues at the University of Washington as a 10-week course. The course developers adapted their course materials to fit the needs of a 16-week semester for the purpose of this study. The Wellness Course teaches students evidence-based skills for improving mental health from dialectical behavior therapy, acceptance and commitment therapy, and the field of positive psychology. Classes meet for 2.5 hours weekly with approximately half of class time spent on teaching new content (lecture) and the other half spent with students working in small groups on practice and discussion exercises.
Controls; Students in this group are enrolled at study sites during the Spring 2020 or Fall 2020 semesters, but are not enrolled in the Wellness Course

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the Wellness Course: Acceptability of Intervention Measure (AIM)	Acceptability of Intervention Measure (AIM) is a 4 item scale. Respondents provide ratings using Likert type ratings ranging from 1-5, where 1= completely disagree and 5=completely agree. The ratings are summed and the average is taken.	End of semester timepoint (approximately 4 months after baseline)
Appropriateness of the Wellness Course: Intervention Appropriateness Measure (IAM)	Intervention Appropriateness Measure (IAM) is a 4 item scale. Respondents provide ratings using Likert type ratings ranging from 1-5, where 1= completely disagree and 5=completely agree. The ratings are summed and the average is taken.	End of semester timepoint (approximately 4 months after baseline)
Feasibility of the Wellness Course: Feasibility of Intervention Measure (FIM)	Feasibility of Intervention Measure (FIM) is a 4 item scale. Respondents provide ratings using Likert type ratings ranging from 1-5, where 1= completely disagree and 5=completely agree. The ratings are summed and the average is taken.	End of semester timepoint (approximately 4 months after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Use of Adaptive Coping Skills from Baseline to End of Semester (approximately 4 months after baseline)	Dialectical Behavior Therapy Ways of Coping Checklist (DBT WCCL) - Adaptive Skills Use Subscale. The DBT WCCL is a 59 item scale for which respondents provide ratings of their coping skills use on a Likert type scale from 0-3, where 0=Never Used and 3=Regularly Used. The adaptive coping sub-scale includes 38 items which are summed and averaged.	Baseline and end of semester (approximately 4 months after baseline)
Change in Use of Adaptive Coping Skills from End of Semester (approximately 4 months after baseline) to 3-Month Follow-up	Dialectical Behavior Therapy Ways of Coping Checklist (DBT WCCL) - Adaptive Skills Use Subscale. The DBT WCCL is a 59 item scale for which respondents provide ratings of their coping skills use on a Likert type scale from 0-3, where 0=Never Used and 3=Regularly Used. The adaptive coping sub-scale includes 38 items which are summed and averaged.	End of semester (approximately 4 months after baseline) and 3-month follow-up
Change in Use of Adaptive Coping Skills from Baseline to 3-Month Follow-up	Dialectical Behavior Therapy Ways of Coping Checklist (DBT WCCL) - Adaptive Skills Use Subscale. The DBT WCCL is a 59 item scale for which respondents provide ratings of their coping skills use on a Likert type scale from 0-3, where 0=Never Used and 3=Regularly Used. The adaptive coping sub-scale includes 38 items which are summed and averaged.	Baseline and 3-month follow-up
Change in Emotion Dysregulation from Baseline to End of Semester (approximately 4 months after baseline)	Difficulties in Emotion Regulation Scale - Short Form is an 18 item scale. Respondents provide ratings on the frequency with which they struggle with various facets of emotion regulation using a Likert type scale ranging from 1-5, where 1= Almost Never (0-10% of the time and 5=Almost Always (91-100% of the time). Scores are summed and the average is taken.	Baseline and end of semester (approximately 4 months after baseline)
Change in Emotion Dysregulation from End of Semester to 3-month follow-up	Difficulties in Emotion Regulation Scale - Short Form is an 18 item scale. Respondents provide ratings on the frequency with which they struggle with various facets of emotion regulation using a Likert type scale ranging from 1-5, where 1= Almost Never (0-10% of the time and 5=Almost Always (91-100% of the time). Scores are summed and the average is taken.	End of semester (approximately 4 months after baseline) and 3-month follow-up
Change in Emotion Dysregulation from Baseline to 3-month follow-up	Difficulties in Emotion Regulation Scale - Short Form is an 18 item scale. Respondents provide ratings on the frequency with which they struggle with various facets of emotion regulation using a Likert type scale ranging from 1-5, where 1= Almost Never (0-10% of the time and 5=Almost Always (91-100% of the time). Scores are summed and the average is taken.	Baseline and 3-month follow-up
Percent of Subjects with Past-30 Day Suicide Ideation at Baseline	Suicide Behaviors Questionnaire - Revised Version is a 4 item scale which assesses suicidality using a range of response options specific to each item, with items indicating higher risk being given more points. Item 1 assesses for suicide ideation and in this study, this is treated as a dichotomous variable.	Baseline
Percent of Subjects with Past-30 Day Suicide Ideation at End of Semester (approximately 4 months after baseline)	Suicide Behaviors Questionnaire - Revised Version is a 4 item scale which assesses suicidality using a range of response options specific to each item, with items indicating higher risk being given more points. Item 1 assesses for suicide ideation and in this study, this is treated as a dichotomous variable.	End of semester (approximately 4 months after baseline)
Percent of Subjects with Past-30 Day Suicide Ideation at 3-month follow-up	Suicide Behaviors Questionnaire - Revised Version is a 4 item scale which assesses suicidality using a range of response options specific to each item, with items indicating higher risk being given more points. Item 1 assesses for suicide ideation and in this study, this is treated as a dichotomous variable.	3-month follow-up
Change in Past-30 Day Suicide Risk from Baseline to End of Semester (approximately 4 months after baseline)	Suicide Behaviors Questionnaire - Revised Version is a 4 item scale which assesses suicidality using a range of response options specific to each item, with items indicating higher risk being given more points. Scores on all 4 items can be summed. In college students a sum score of greater than or equal to 7 is associated with current suicide risk.	Baseline and end of semester (approximately 4 months after baseline)
Change in Past-30 Day Suicide Risk from End of Semester (approximately 4 months after baseline) to 3-month follow-up	Suicide Behaviors Questionnaire - Revised Version is a 4 item scale which assesses suicidality using a range of response options specific to each item, with items indicating higher risk being given more points. Scores on all 4 items can be summed. In college students a sum score of greater than or equal to 7 is associated with current suicide risk.	End of semester (approximately 4 months after baseline) and 3-month follow-up
Change in Past-30 Day Suicide Risk from Baseline to 3-month follow-up	Suicide Behaviors Questionnaire - Revised Version is a 4 item scale which assesses suicidality using a range of response options specific to each item, with items indicating higher risk being given more points. Scores on all 4 items can be summed. In college students a sum score of greater than or equal to 7 is associated with current suicide risk.	Baseline and 3-month follow-up

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Citrone 33 Foundation
• Investigators: Principal Investigator: Carla D Chugani, PhD, University of Pittsburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 9, 2019
• Primary Completion (ACTUAL): December 23, 2020
• Study Completion (ACTUAL): April 13, 2021

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (ACTUAL): April 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Dialectical Behavior Therapy; Public Health; College Students; Mental Health Education
• Other Study ID Numbers: STUDY18120150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No