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Clinical Trials/NCT04558411
NCT04558411
Completed
Not Applicable

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

Rutgers, The State University of New Jersey1 site in 1 country153 target enrollmentSeptember 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emotional Regulation
Sponsor
Rutgers, The State University of New Jersey
Enrollment
153
Locations
1
Primary Endpoint
Emotion regulation
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 12, 2020
End Date
December 15, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shireen L. Rizvi, PhD, ABPP

Associate Professor

Rutgers, The State University of New Jersey

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Emotion regulation

Time Frame: 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

Time Frame: 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)

Time Frame: Six week daily monitoring period

Assessed via EMA in the experimental group, 0 through 10 scale, 10 equals more distress.

Secondary Outcomes

  • Maintenance of improvement in emotion regulation(Six week post-daily monitoring period)

Study Sites (1)

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