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

NCT ID: NCT04287374

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Well-Being Depressive Symptoms Anxiety Affect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Multi-component Well-being Intervention

Intervention Type 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 Control

Reading and writing activities designed to teach evidence-based study strategies.

Group Type SHAM_COMPARATOR

Study Skills

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert DeRubeis, PhD

Role: STUDY_DIRECTOR

University of Pennsylvania

Akash Wasil

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Harvard University

Cambridge, Massachusetts, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

834854

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MIndfulness for Students
NCT03669016 UNKNOWN NA