A Mobile App to Address Student Loneliness

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

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.

Study Overview

• Status: Completed
• Conditions: Loneliness
• Intervention / Treatment: Behavioral: Loneliness Intervention

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 Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • University of Oregon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental-Immediate Access to the Nod app; 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.	Behavioral: Loneliness Intervention; 28 days of engagement with the Nod app, which consists of interactive exercises drawn from cognitive behavioral therapy (e.g behavioral activation and cognitive reframing exercises), positive psychology (e.g. acts of kindness), and mindful self-compassion programs (e.g. loving-kindness meditations); Other Names: A mobile app called Nod
Other: Waitlist Control-Delayed Access to the Nod app; The waitlist control group will have full access to the Nod app approximately four weeks after the experimental group gains access.	Behavioral: Loneliness Intervention; 28 days of engagement with the Nod app, which consists of interactive exercises drawn from cognitive behavioral therapy (e.g behavioral activation and cognitive reframing exercises), positive psychology (e.g. acts of kindness), and mindful self-compassion programs (e.g. loving-kindness meditations); Other Names: A mobile app called Nod

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Condition differences in self-reported loneliness	Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.	2-weeks post baseline
Condition differences in self-reported loneliness	Total score on the UCLA-8. Scores range from 8-32, higher scores indicate worse depression.	4-weeks post baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oregon
• Collaborators: National Institute on Drug Abuse (NIDA); HopeLab Foundation

Publications and helpful links

General Publications

• Bruehlman-Senecal E, Hook CJ, Pfeifer JH, FitzGerald C, Davis B, Delucchi KL, Haritatos J, Ramo DE. Smartphone App to Address Loneliness Among College Students: Pilot Randomized Controlled Trial. JMIR Ment Health. 2020 Oct 20;7(10):e21496. doi: 10.2196/21496.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): May 6, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 06072019.014; R34DA041637 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No