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Completed

NCT Number: NCT04164654

A Mobile App to Address Student Loneliness

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.

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Key information

Conditions

Loneliness

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon

Eugene, Oregon, 97403, United States

About this study

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:

  • Experimental group: Immediate access to the Nod app
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loneliness Intervention

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Depressive symptoms

    Time frame: 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.

  2. Anxiety

    Time frame: 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.

  3. Social Anxiety

    Time frame: 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.

  4. Self-reported intention to remain enrolled at the University of Oregon in the next academic year

    Time frame: 2 and 4 weeks post baseline

    Self-reported intention to remain enrolled at the University of Oregon in the next academic year

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

  • HopeLab Foundation
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 15, 2019
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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