A Mobile App to Address Student Loneliness

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164654
• Other study ID #: 06072019.014
• Secondary ID: R34DA041637
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: May 6, 2021

Study information

• Verified date: September 2022
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: May 6, 2021
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Loneliness

Intervention

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)

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
University of Oregon	HopeLab Foundation, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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