A Mobile App to Address Student Loneliness

Study Overview
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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: 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.

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

Conditions
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Loneliness

Intervention / Treatment
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* Behavioral: Loneliness Intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental-Immediate Access to the Nod app<br>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<br>* 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)<br>* Other names: A mobile app called Nod;|
| Other: Waitlist Control-Delayed Access to the Nod app<br>The waitlist control group will have full access to the Nod app approximately four weeks after the experimental group gains access. | Behavioral: Loneliness Intervention<br>* 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)<br>* Other names: A mobile app called Nod;|

What is the study measuring?
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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 |