Brief, Scaleable Intervention for Coronavirus (COVID-19) Mental Health Sequelae in College Students

Emotional Regulation Clinical Trial

Official title:

Pilot Study of a Brief, Scaleable Intervention for COVID-19 Mental Health Sequelae in College Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558411
• Other study ID #: Pro2020002008
• Status: Completed
• Phase: N/A
• Start date: September 12, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: September 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The major aim of this pilot study is to evaluate a brief coping skills intervention for college students, based on an evidence-based treatment and delivered remotely via 14 short daily videos. Participants will be 150 Rutgers undergraduates who are enrolled in Fall 2020. Participants in the experimental group (n=100) will receive 4 daily smartphone surveys assessing stress, affect, and other related factors for two weeks before, during, and after the 2-week coping skills intervention. Participants in the control group (n=50) will receive assessments over the same time period with no skills intervention. Both groups will be assessed weekly throughout the Fall semester to monitor the transition to the new semester and longer-term impact of the intervention. The control condition participants will have access to the skills videos at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age 18 years or older

• Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)

• Currently residing in the United States

• Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures

• iOS and Android smartphone compatible with MetricWire

Exclusion Criteria

• Non-English speaking

• Unable to understand or provide informed consent

Related Conditions & MeSH terms

• Affect
• COVID-19
• Emotional Regulation

Intervention

Behavioral:
• Dialectical Behavioral Therapy (DBT) Skills
14 brief videos that teach DBT skills.

Locations

Country	Name	City	State
United States	Rutgers, The State University of New Jersey	Piscataway	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress	Distress, as assessed via smartphone Ecological Momentary Assessment (EMA), 0 through 10 scale, 10 equals more distress.	Six week daily monitoring period
Primary	Emotion regulation	Assessed with the Difficulties in Emotion Regulation Scale (DERS); scores range from 36-180, higher scores equal more distress	Six week daily monitoring period
Primary	Distress (within-person change)	Assessed via EMA in the experimental group, 0 through 10 scale, 10 equals more distress.	Six week daily monitoring period
Secondary	Maintenance of improvement in emotion regulation	Assessed with the Difficulties in Emotion Regulation Scale (DERS), scores range from 36-180, higher scores equal more distress	Six week post-daily monitoring period