NCT04287374

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

February 24, 2020

Last Update Submit

September 3, 2020

Conditions

Well-BeingDepressive SymptomsAnxietyAffect

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Acceptability of Intervention Measure

    Immediately post-intervention (0 weeks)

  • Feasibility of Intervention Measure

    Immediately post-intervention (0 weeks)

  • Intervention Appropriateness Measure

    Immediately post-intervention (0 weeks)

  • Change in Gratitude Questionnaire-6

    Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

  • Change in Beck Hopelessness Scale (4-item version)

    Change from baseline at 2 week follow-up, 4 week follow-up, 12 week follow-up

  • +2 more secondary outcomes

Study Arms (2)

Multi-component Well-being Intervention

EXPERIMENTAL

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

Study Skills Control

SHAM COMPARATOR

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

Behavioral: Study Skills

Interventions

Multi-component Well-being InterventionBEHAVIORAL

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.

Multi-component Well-being Intervention
Study SkillsBEHAVIORAL

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.

Study Skills Control

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current undergraduate student at select universities
  • Able to access the internet
  • Can participate in follow-up surveys for three months post sign-up

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Harvard University

Cambridge, Massachusetts, 01434, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Robert DeRubeis, PhD

    University of Pennsylvania

    STUDY DIRECTOR

  • Akash Wasil

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 27, 2020

Study Start

March 31, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)