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

Not Applicable

Completed

• Conditions: Affect; Well-Being; Anxiety; Depressive Symptoms
• Interventions: Behavioral: Multi-component Well-being Intervention; Behavioral: Study Skills

• Registration Number: NCT04287374
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Study Start: 2020-03-31
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-component Well-being Intervention	Multi-component Well-being Intervention	Reading and writing activities based on cognitive restructuring (rephrasing automatic negative thoughts), gratitude (noticing and appreciating good things in life), and behavioral activation (identifying and scheduling positive activities)
Study Skills Control	Study Skills	Reading and writing activities designed to teach evidence-based study strategies.

Primary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire-9 (PHQ-9)	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)	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	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 Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale-4	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up	Perceived stress questionnaire. Total score ranges from 0 to 16. Higher scores indicate more stress.
Acceptability of Intervention Measure	Immediately post-intervention (0 weeks)	Questionnaire measuring the acceptability of an intervention. Acceptability refers to the perception that a given treatment is agreeable or satisfactory. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Feasibility of Intervention Measure	Immediately post-intervention (0 weeks)	Questionnaire measuring the feasibility of an intervention. Feasibility refers to the degree to which a treatment can be successfully implemented in a given setting. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Intervention Appropriateness Measure	Immediately post-intervention (0 weeks)	Questionnaire measuring the appropriateness of an intervention. Appropriateness refers to the perceived fit or relevance of an intervention. The total score ranges from 4 to 20. Higher scores indicate a better outcome.
Change in Gratitude Questionnaire-6	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up	Gratitude questionnaire. Total score ranges from 6 to 42. Higher scores indicate more gratitude.
Change in Beck Hopelessness Scale (4-item version)	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up	Hope Questionnaire. Total score ranges from 0 to 4. Higher scores indicate less hope (or more hopelessness).
Change in Positive and Negative Affect Schedule	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up	Affect Questionnaire. Scores range from 10-50 for positive affect and negative affect subscales. Higher scores represent higher levels of affect.

Trial Locations

Locations (2)

Harvard University; 🇺🇸 Cambridge, Massachusetts, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States