Mental Health IssueNCT04338256
Mental Health Curriculum Study
An observational study of Mental Health Issue, run by University of Pittsburgh at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Wellness and Resilience for College and Beyond (Undergraduate College Course)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 295 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Dec 2019to 13 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population is undergraduate college students recruited from five college campuses in Pennsylvania and West Virginia.
Who may be able to join
- Undergraduate College Students
- Enrolled at one of the five study sites
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Pittsburgh, Greensburg Campus
Greensburg, Pennsylvania, 15601
West Virginia University
Morgantown, West Virginia, 26506
Carlow University
Pittsburgh, Pennsylvania, 15213
Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: 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.
- Conditions
- Mental Health Issue
- Being tested
- Wellness and Resilience for College and Beyond (Undergraduate College Course)
- Keywords
- Mental Health Education, Public Health, Dialectical Behavior Therapy, College Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness and Resilience for College and Beyond (Undergraduate College Course)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Students enrolled in the Wellness Course | Students in this group are enrolled in the Wellness Course for the Spring 2020 or Fall 2020 semesters Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start9 Dec 2019
- Primary completion23 Dec 2020
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Citrone 33 Foundation
- Responsible party
- Principal investigator, Carla Chugani, University of Pittsburgh
- Investigators
- Carla D Chugani, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338256
- Sponsor's protocol ID
- STUDY18120150
- Status last verified
- Apr 2021
- First submitted
- 3 Apr 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32565475
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness and Resilience for College and Beyond: A Quasi-Experimental Pilot Study Investigating a Dialectical Behavior Therapy Skills-Infused College Course
- ClinicalTrials.gov ID
- NCT04338256
- Acronym / sponsor ID
- STUDY18120150
- Conditions
- Mental Health Issue
- Keywords
- Mental Health Education, Public Health, Dialectical Behavior Therapy, College Students
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Citrone 33 Foundation
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Students enrolled in the Wellness Course | – | Behavioral: Wellness and Resilience for College and Beyond (Undergraduate College Course)Students in this group are enrolled in the Wellness Course for the Spring 2020 or Fall 2020 semesters |
| 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 |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is undergraduate college students recruited from five college campuses in Pennsylvania and West Virginia.
Key inclusion criteria (2 listed)
- Undergraduate College Students
- Enrolled at one of the five study sites
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Students enrolled in the Wellness Course |
Primary outcome
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.
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.
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.
12 secondary outcomes
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)
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
Change in Use of Adaptive Coping Skills from Baseline to 3-Month Follow-up
Time frame: 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)
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
Change in Emotion Dysregulation from Baseline to 3-month follow-up
Time frame: Baseline and 3-month follow-up
Percent of Subjects with Past-30 Day Suicide Ideation at Baseline
Time frame: 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)
Percent of Subjects with Past-30 Day Suicide Ideation at 3-month follow-up
Time frame: 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)
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
Change in Past-30 Day Suicide Risk from Baseline to 3-month follow-up
Time frame: Baseline and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 32565475Chugani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla D Chugani, PhD principal investigator
University of Pittsburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue, run by University of Pittsburgh at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Wellness Course: Acceptability of Intervention Measure (AIM) (time frame: End of semester timepoint (approximately 4 months after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04338256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.