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

NCT ID: NCT04558411

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-12

Study Completion Date

2020-12-15

Brief Summary

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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

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Conditions

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Emotional Regulation Affect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Group (assessment only)

This group will receive assessments only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Assessment + Intervention Group

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

Group Type EXPERIMENTAL

Dialectical Behavioral Therapy (DBT) Skills

Intervention Type BEHAVIORAL

14 brief videos that teach DBT skills.

Interventions

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Dialectical Behavioral Therapy (DBT) Skills

14 brief videos that teach DBT skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Shireen L. Rizvi, PhD, ABPP

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rutgers, The State University of New Jersey

Piscataway, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Pro2020002008

Identifier Type: -

Identifier Source: org_study_id

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