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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA041637 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| HopeLab Foundation | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oregon | Eugene | Oregon | 97403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33079071 | Derived | 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. |
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| 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 |