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OpenTrials
Completed

NCT Number: NCT04558411

Brief, Scaleable Intervention for Coronavirus (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.

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Key information

Conditions

Emotional Regulation Affect Behavior Self-Control Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers, The State University of New Jersey

Piscataway, New Jersey, 08854, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialectical Behavioral Therapy (DBT) Skills

Behavioral

14 brief videos that teach DBT skills.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  1. Maintenance of improvement in emotion regulation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 22, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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