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Completed

NCT Number: NCT04287374

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.

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Key information

Conditions

Well-Being Affect Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Symptoms Mental Disorders

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard University, Cambridge, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-component Well-being Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Acceptability of Intervention Measure

    Time frame: 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.

  2. Feasibility of Intervention Measure

    Time frame: 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.

  3. Intervention Appropriateness Measure

    Time frame: 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.

  4. Change in Gratitude Questionnaire-6

    Time frame: 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.

  5. Change in Beck Hopelessness Scale (4-item version)

    Time frame: 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).

  6. Change in Perceived Stress Scale-4

    Time frame: 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.

  7. Change in Positive and Negative Affect Schedule

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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