A Mobile App to Address Student Loneliness

NCT ID: NCT04164654

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2021-05-06

Brief Summary

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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

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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.

Conditions

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Loneliness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Loneliness Intervention

Intervention Type 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)

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.

Group Type OTHER

Loneliness Intervention

Intervention Type 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)

Interventions

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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)

Intervention Type BEHAVIORAL

Other Intervention Names

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A mobile app called Nod

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HopeLab Foundation

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Oregon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Oregon

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33079071 (View on PubMed)

Other Identifiers

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R34DA041637

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06072019.014

Identifier Type: -

Identifier Source: org_study_id

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