A Mobile App to Address Student Loneliness

Not Applicable

Completed

• Conditions: Loneliness

• Registration Number: NCT04164654
• Lead Sponsor: University of Oregon

Brief Summary

The purpose of this trial is to assess the effects of a positive psychology and CBT-based skills intervention-delivered through a mobile app called Nod-on loneliness and other mental health and institutional satisfaction outcomes. The primary outcome is self-reported loneliness at 2 and 4-weeks post baseline.

Detailed Description

This study is a pilot eight-week randomized controlled intervention. It employs a "waitlist" control strategy for the first 4 weeks of the study (considered to be the active study period).

Randomization will be to one of two conditions:

1. Experimental group: Immediate access to the Nod app

2. Waitlist control group: Participants will be granted access to the app four weeks after the experimental group

Assessments will occur at baseline, 2, 4, and 8 weeks follow up. Assessments will include measures of loneliness, and other mental health and institutional satisfaction measures listed in the secondary outcome measures section.

Study Timeline

• Study Start: 2019-09-09
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Primary Completion: 2020-10-20
• Study Completion: 2021-05-06
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

• Incoming college first years
• Live away from home without parents/guardians upon beginning college
• Read English
• Between 18 and 25 years of age
• Own a smartphone

Exclusion Criteria

• Do not read English
• Under 18 years of age
• Over 25 years of age
• Do not own a smartphone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Condition differences in self-reported loneliness	4-weeks post baseline	Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms	2 and 4 weeks post baseline	Total score on the Patient Health Questionnaire 9-item scale. Scores range from 0-27, higher scores indicate worse depression.
Social Anxiety	2 and 4 weeks post baseline	Total score on the Mini Social Phobia Inventory. Scores range from 0-12, higher scores indicate worse social anxiety.
Self-reported intention to remain enrolled at the University of Oregon in the next academic year	2 and 4 weeks post baseline	Self-reported intention to remain enrolled at the University of Oregon in the next academic year
Anxiety	2 and 4 weeks post baseline	Total score on the Generalized Anxiety Disorder 7-item scale. Scores range from 0-21, higher scores indicate worse anxiety.

Trial Locations

Locations (1)

University of Oregon; 🇺🇸 Eugene, Oregon, United States