A Mobile App to Address Student Loneliness

Not Applicable

Completed

• Conditions: Loneliness
• Interventions: Behavioral: Loneliness Intervention

• 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

Arm && Interventions

Group	Intervention	Description
Waitlist Control-Delayed Access to the Nod app	Loneliness Intervention	The waitlist control group will have full access to the Nod app approximately four weeks after the experimental group gains access.
Experimental-Immediate Access to the Nod app	Loneliness Intervention	The experimental group will have immediate access to all content in the Nod app and will be free to engage with it as much or as little as they like for four weeks. They will retain access to the Nod app for an additional four weeks.

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