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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Depressive Symptoms; Affect; Well-Being
• Intervention / Treatment: Behavioral: Multi-component Well-being Intervention; Behavioral: Study Skills

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 Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 01434
      • Harvard University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Behavioral: Multi-component Well-being Intervention; The intervention asks participants to complete exercises based on three different skills. These skills include cognitive restructuring, gratitude and behavioral activation. After completing the program, participants will pick their favorite exercise to complete on a weekly basis for homework. In order to increase compliance with the homework, participants will complete a short plan in which they will identify when, where and with who they will complete the homework. The whole intervention takes approximately 20-30 minutes to complete.
Sham Comparator: Study Skills Control; Reading and writing activities designed to teach evidence-based study strategies.	Behavioral: Study Skills; Participants are taught three different study skills/strategies. They are asked to make a plan to continue using these strategies after completing the intervention. The whole intervention takes approximately 20-30 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire-9 (PHQ-9)	Depression Questionnaire. The total score ranges from 0 to 27. Lower scores indicate a better outcome.	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Generalized Anxiety Disorder Screener-7 (GAD-7)	Anxiety Questionnaire. The total score ranges from 0 to 21. Lower scores indicate a better outcome.	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in The Warwick-Edinburgh Mental Wellbeing Scale	Well-being questionnaire. Total score ranges from 14 to 70. Higher values indicate a better outcome.	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention Measure	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.	Immediately post-intervention (0 weeks)
Feasibility of Intervention Measure	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.	Immediately post-intervention (0 weeks)
Intervention Appropriateness Measure	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.	Immediately post-intervention (0 weeks)
Change in Gratitude Questionnaire-6	Gratitude questionnaire. Total score ranges from 6 to 42. Higher scores indicate more gratitude.	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Beck Hopelessness Scale (4-item version)	Hope Questionnaire. Total score ranges from 0 to 4. Higher scores indicate less hope (or more hopelessness).	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Perceived Stress Scale-4	Perceived stress questionnaire. Total score ranges from 0 to 16. Higher scores indicate more stress.	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up
Change in Positive and Negative Affect Schedule	Affect Questionnaire. Scores range from 10-50 for positive affect and negative affect subscales. Higher scores represent higher levels of affect.	Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Study Director: Robert DeRubeis, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 834854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No