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

Not Applicable

Completed

• Conditions: Emotional Regulation; Affect
• Interventions: Behavioral: Dialectical Behavioral Therapy (DBT) Skills

• Registration Number: NCT04558411
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-12
• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-20
• Study First Posted: 2020-09-22
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Assessment + Intervention Group	Dialectical Behavioral Therapy (DBT) Skills	This group will receive assessments and the 14 brief intervention videos.

Primary Outcome Measures

Name	Time	Method
Emotion regulation	Six week daily monitoring period	Assessed with the Difficulties in Emotion Regulation Scale (DERS); scores range from 36-180, higher scores equal more distress
Distress	Six week daily monitoring period	Distress, as assessed via smartphone Ecological Momentary Assessment (EMA), 0 through 10 scale, 10 equals more distress.
Distress (within-person change)	Six week daily monitoring period	Assessed via EMA in the experimental group, 0 through 10 scale, 10 equals more distress.

Secondary Outcome Measures

Name	Time	Method
Maintenance of improvement in emotion regulation	Six week post-daily monitoring period	Assessed with the Difficulties in Emotion Regulation Scale (DERS), scores range from 36-180, higher scores equal more distress

Trial Locations

Locations (1)

Rutgers, The State University of New Jersey; 🇺🇸 Piscataway, New Jersey, United States