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

NCT04558411 | Completed

• 1 other identifier: Pro2020002008
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Regulation; Affect

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Maintenance of improvement in emotion regulation

  Six week post-daily monitoring period

Study Arms (2)

Control Group (assessment only)

NO INTERVENTION

This group will receive assessments only.

Assessment + Intervention Group

EXPERIMENTAL

This group will receive assessments and the 14 brief intervention videos.

Behavioral: Dialectical Behavioral Therapy (DBT) Skills

Interventions

Dialectical Behavioral Therapy (DBT) Skills BEHAVIORAL

14 brief videos that teach DBT skills.

Assessment + Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speaking
• Unable to understand or provide informed consent

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers, The State University of New Jersey

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 22, 2020
• Study Start: September 12, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: We will share data after the publication of primary manuscripts.

Locations

US (1)