Mental Health Curriculum Study

NCT04338256 | Completed

• 1 other identifier: STUDY18120150
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 5

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.

Conditions

Mental Health Issue

Keywords

Mental Health Education; Public Health; Dialectical Behavior Therapy; College Students

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Change in Use of Adaptive Coping Skills from Baseline to End of Semester (approximately 4 months after baseline)

  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

  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

  Baseline and 3-month follow-up

• Change in Emotion Dysregulation from Baseline to End of Semester (approximately 4 months after baseline)

  Baseline and end of semester (approximately 4 months after baseline)

• Change in Emotion Dysregulation from End of Semester to 3-month follow-up

  End of semester (approximately 4 months after baseline) and 3-month follow-up

Study Arms (2)

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)

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

Interventions

Wellness and Resilience for College and Beyond (Undergraduate College Course) BEHAVIORAL

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.

Students enrolled in the Wellness Course

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Citrone 33 Foundation: collaborator

Study Sites (5)

University of Pittsburgh, Greensburg Campus

Greensburg, Pennsylvania, 15601, United States

Location

Carlow University

Pittsburgh, Pennsylvania, 15213, United States

Location

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 32565475 DERIVED

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Carla D Chugani, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 8, 2020
• Study Start: December 9, 2019
• Primary Completion: December 23, 2020
• Study Completion: April 13, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)