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

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

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.

Study Overview

• Status: Completed
• Conditions: Emotional Regulation; Affect
• Intervention / Treatment: Behavioral: Dialectical Behavioral Therapy (DBT) Skills

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854
      • Rutgers, The State University of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control Group (assessment only); This group will receive assessments only.
EXPERIMENTAL: Assessment + Intervention Group; This group will receive assessments and the 14 brief intervention videos.	Behavioral: Dialectical Behavioral Therapy (DBT) Skills; 14 brief videos that teach DBT skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress	Distress, as assessed via smartphone Ecological Momentary Assessment (EMA), 0 through 10 scale, 10 equals more distress.	Six week daily monitoring period
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 12, 2020
• Primary Completion (ACTUAL): December 15, 2020
• Study Completion (ACTUAL): December 15, 2020

Study Registration Dates

• First Submitted: September 20, 2020
• First Submitted That Met QC Criteria: September 20, 2020
• First Posted (ACTUAL): September 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Pro2020002008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share data after the publication of primary manuscripts.
• IPD Sharing Time Frame: We will share data after the publication of primary manuscripts.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No