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Clinical Trials/NCT04287374
NCT04287374
Completed
Not Applicable

The Effects of Online Single-Session Interventions on College Student Well-being

University of Pennsylvania2 sites in 1 country294 target enrollmentMarch 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Well-Being
Sponsor
University of Pennsylvania
Enrollment
294
Locations
2
Primary Endpoint
Change in Patient Health Questionnaire-9 (PHQ-9)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2020
End Date
August 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in Patient Health Questionnaire-9 (PHQ-9)

Time Frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.

Change in Generalized Anxiety Disorder Screener-7 (GAD-7)

Time Frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.

Change in The Warwick-Edinburgh Mental Wellbeing Scale

Time Frame: Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.

Secondary Outcomes

  • Change in Perceived Stress Scale-4(Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up)
  • Acceptability of Intervention Measure(Immediately post-intervention (0 weeks))
  • Feasibility of Intervention Measure(Immediately post-intervention (0 weeks))
  • Intervention Appropriateness Measure(Immediately post-intervention (0 weeks))
  • Change in Gratitude Questionnaire-6(Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up)
  • Change in Beck Hopelessness Scale (4-item version)(Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up)
  • Change in Positive and Negative Affect Schedule(Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up)

Study Sites (2)

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