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Clinical Trials/NCT04164654
NCT04164654CompletedNot Applicable

Using a Mobile App to Address Student Loneliness Among College Students: A Randomized Controlled Trial

University of Oregon1 site in 1 country221 target enrollmentStarted: September 9, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
221
Locations
1
Primary Endpoint
Condition differences in self-reported loneliness

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Experimental-Immediate Access to the Nod app

Experimental

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.

Intervention: Loneliness Intervention (Behavioral)

Waitlist Control-Delayed Access to the Nod app

Other

The waitlist control group will have full access to the Nod app approximately four weeks after the experimental group gains access.

Intervention: Loneliness Intervention (Behavioral)

Outcomes

Primary Outcomes

Condition differences in self-reported loneliness

Time Frame: 4-weeks post baseline

Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.

Condition differences in self-reported loneliness

Time Frame: 2-weeks post baseline

Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.

Secondary Outcomes

  • Depressive symptoms(2 and 4 weeks post baseline)
  • Social Anxiety(2 and 4 weeks post baseline)
  • Self-reported intention to remain enrolled at the University of Oregon in the next academic year(2 and 4 weeks post baseline)
  • Anxiety(2 and 4 weeks post baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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