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

Study 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.

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

Conditions
-----------------
Emotional Regulation, Affect

Intervention / Treatment
-----------------
* Behavioral: Dialectical Behavioral Therapy (DBT) Skills


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group (assessment only)<br>This group will receive assessments only. | |
| Experimental: Assessment + Intervention Group<br>This group will receive assessments and the 14 brief intervention videos. | Behavioral: Dialectical Behavioral Therapy (DBT) Skills<br>* 14 brief videos that teach DBT skills.<br>|

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 |