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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287374
• Other study ID #: 834854
• Status: Completed
• Phase: N/A
• Start date: March 31, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

• Affect
• Anxiety
• Depression
• Depressive Symptoms
• Well-Being

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Harvard University	Cambridge	Massachusetts
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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