A Mobile App to Address Student Loneliness

NCT04164654 | Completed

• 2 other identifiers: 06072019.014R34DA041637
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Loneliness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Depressive symptoms

  2 and 4 weeks post baseline

• Anxiety

  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

Study Arms (2)

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.

Behavioral: Loneliness Intervention

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.

Behavioral: Loneliness Intervention

Interventions

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)

Also known as: A mobile app called Nod

Experimental-Immediate Access to the Nod app; Waitlist Control-Delayed Access to the Nod app

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Do not read English
• Under 18 years of age
• Over 25 years of age
• Do not own a smartphone

Sponsors & Collaborators

• University of Oregon: lead
• HopeLab Foundation: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

• 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.

  PMID: 33079071 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: September 9, 2019
• Primary Completion: October 20, 2020
• Study Completion: May 6, 2021
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)