Clinical trial NCT04287374: The Effects of Online Single-Session Interventions on College Student Well-being
Official title: The Effects of Online Single-Session Interventions on College Student Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-Being
Depressive Symptoms
Anxiety
Affect
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study seeks to investigate the effects of an online single-session intervention on college student mental health and well-being. Undergraduate students from the University of Pennsylvania and Harvard will be randomized to a 30-minute single-session intervention or a study skills control group. Students' depressive symptoms, anxiety symptoms, positive and negative affect, and subjective well-being will be assessed up to 12 weeks post-intervention.

Detailed description: The design of our study is a randomized control trial. After enrollment in the study, participants will randomly assigned to one of two conditions. In each condition, participants will be asked to complete an initial survey of mental health and well-being measures. Following this survey, participants will complete either a well-being skills single-session intervention or control single-session intervention (study skills) depending on which condition they were assigned to. These single-session interventions educate the participant on their focal concept and teach them exercises to improve that skill. Completing the single-session intervention will take approximately 20-30 minutes.

After completing their single-session intervention, all participants will retake the measures of mental health and well-being presented to them at the beginning of the program. Participants will also be asked to complete measures of intervention feasibility, acceptability and appropriateness at this time.

Following this initial intervention, participants will retake the measures of well-being and mental health at 2 weeks, 4 weeks, and 12 weeks after they completed the intervention. This will allow us to fulfill our first objective by determining how long single-session interventions improve undergraduate mental health and well-being.

Eligibility criteria: Inclusion Criteria:

* Current undergraduate student at select universities
* Able to access the internet
* Can participate in follow-up surveys for three months post sign-up

Exclusion Criteria:

* Unable to access the internet
* Will not be able to respond to the follow-up surveys post-intervention

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
measure: Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
timeFrame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
measure: Change in The Warwick-Edinburgh Mental Wellbeing Scale
timeFrame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Secondary outcomes:
measure: Acceptability of Intervention Measure
timeFrame: Immediately post-intervention (0 weeks)
measure: Feasibility of Intervention Measure
timeFrame: Immediately post-intervention (0 weeks)
measure: Intervention Appropriateness Measure
timeFrame: Immediately post-intervention (0 weeks)
measure: Change in Gratitude Questionnaire-6
timeFrame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
measure: Change in Beck Hopelessness Scale (4-item version)
timeFrame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
measure: Change in Perceived Stress Scale-4
timeFrame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
measure: Change in Positive and Negative Affect Schedule
timeFrame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Robert DeRubeis, PhD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Akash Wasil
role: PRINCIPAL_INVESTIGATOR
References: