Mental Health Curriculum Study

April 14, 2021 updated by: Carla Chugani, University of Pittsburgh

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
295

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of the Wellness Course: Acceptability of Intervention Measure (AIM)
Time Frame: End of semester timepoint (approximately 4 months after baseline)
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)
Time Frame: End of semester timepoint (approximately 4 months after baseline)
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)
Time Frame: End of semester timepoint (approximately 4 months after baseline)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Use of Adaptive Coping Skills from Baseline to End of Semester (approximately 4 months after baseline)
Time Frame: Baseline and 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
Time Frame: End of semester (approximately 4 months after baseline) and 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
Time Frame: Baseline and 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)
Time Frame: Baseline and 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
Time Frame: End of semester (approximately 4 months after baseline) and 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
Time Frame: Baseline and 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: Baseline and 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
Time Frame: End of semester (approximately 4 months after baseline) and 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
Time Frame: Baseline and 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Citrone 33 Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carla D Chugani, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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