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This between-subject, longitudinal pilot study in healthy college students aims to explore the acceptability and preliminary outcomes of two novel and complementary interventions that may improve stress and sleep: transcutaneous vagus nerve stimulation (tVNS) and a mobile mindfulness intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tVNS + mindfulness | Experimental | Transcutaneous vagus nerve stimulation plus behavioral: mindfulness |
|
| Sham + mindfulness | Sham Comparator | Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness |
|
| Mindfulness only | Active Comparator |
| |
| Control | Active Comparator | Control number puzzle task delivered via mobile device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tVNS | Device | transcutaneous vagus nerve stimulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) | The AIM (Weiner et al., 2017) is a brief 4-item scale measuring the degree to which participants believe an intervention is acceptable. The response scale for each item ranges from 1 (completely disagree) to 5 (completely agree). Responses from the 4 items are averaged to yield total scores ranging from 1-5, with higher scores indicating greater acceptability. | Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2 |
| Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) | The PSQI (Buysse et al., 1989) contains 19 self-rated items that are combined to form seven component scores, each of which has a range from 0-3 points. For each component, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range from 0-21 points (0 = best sleep quality, 21 = poorest sleep quality). | Assessed at the end of the intervention phase (Week 4) |
| Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) | The PSS (Cohen et al., 1994) is a 10-item questionnaire measuring the degree to which situations in one's life are appraised as stressful. In particular, it gauges how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate each item on a scale of 0 (never) to 4 (very often), and total scores range from 0-40 (0 = least perceived stress, 40 = most perceived stress). | Assessed at the end of the intervention phase (Week 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Bottari, M.S. | University of Florida | Principal Investigator |
| Liva LaMontagne, Dr. Psych. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32601 | United States |
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Participants were assigned to study arms/groups pseudo-randomly upon scheduling an intake appointment (prior to enrollment).
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| ID | Title | Description |
|---|---|---|
| FG000 | tVNS + Mindfulness | Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application |
| FG001 | Sham + Mindfulness | Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation |
| FG002 | Mindfulness Only | Mindfulness: Brightmind mobile mindfulness application |
| FG003 | Control | Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 participant in the tVNS + mindfulness group and 3 participants in the sham + mindfulness group were screened out of the study during the intake visit after enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | tVNS + Mindfulness | Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application |
| BG001 | Sham + Mindfulness |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) | The AIM (Weiner et al., 2017) is a brief 4-item scale measuring the degree to which participants believe an intervention is acceptable. The response scale for each item ranges from 1 (completely disagree) to 5 (completely agree). Responses from the 4 items are averaged to yield total scores ranging from 1-5, with higher scores indicating greater acceptability. | Enrolled participants in the tVNS + mindfulness groups and sham + mindfulness groups who completed the Week 2 questionnaires at the appropriate timeframe were included in the analysis. Results are not reported for the Mindfulness only and Control groups, as these participants did not receive the tVNS portion of the combined intervention. Therefore, they did not complete the AIM measure asking about acceptability of the tVNS intervention and data was not available to report on for those groups. | Posted | Mean | Standard Deviation | units on a scale | Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2 |
During participants' active participation in the study (4 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tVNS + Mindfulness | Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uncomfortable variation in stimulation intensity at stimulation site | Product Issues | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Bottari, M.S. | University of Florida | (352) 273-6455 | sbottari@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2022 | Apr 2, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Mindfulness |
| Behavioral |
Brightmind mobile mindfulness application |
|
| sham tVNS | Device | sham transcutaneous vagus nerve stimulation |
|
| Number Puzzle | Other | Control number puzzle task delivered via mobile device |
|
Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Mindfulness: Brightmind mobile mindfulness application
sham tVNS: sham transcutaneous vagus nerve stimulation
| BG002 | Mindfulness Only | Mindfulness: Brightmind mobile mindfulness application |
| BG003 | Control | Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Pittsburg Sleep Quality Index (PSQI) | The PSQI (Buysse et al., 1989) contains 19 self-rated items that are combined to form seven component scores, each of which has a range from 0-3 points. For each component, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range from 0-21 points (0 = best sleep quality, 21 = poorest sleep quality). | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress Scale (PSS) | The PSS (Cohen et al., 1994) is a 10-item questionnaire measuring the degree to which situations in one's life are appraised as stressful. In particular, it gauges how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate each item on a scale of 0 (never) to 4 (very often), and total scores range from 0-40 (0 = least perceived stress, 40 = most perceived stress). | Mean | Standard Deviation | units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | tVNS + Mindfulness | Transcutaneous vagus nerve stimulation plus behavioral: mindfulness tVNS: transcutaneous vagus nerve stimulation Mindfulness: Brightmind mobile mindfulness application |
| OG001 | Sham + Mindfulness | Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation |
|
|
| Primary | Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) | The PSQI (Buysse et al., 1989) contains 19 self-rated items that are combined to form seven component scores, each of which has a range from 0-3 points. For each component, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range from 0-21 points (0 = best sleep quality, 21 = poorest sleep quality). | Enrolled participants who completed the Week 4 questionnaires during an appropriate timeframe were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessed at the end of the intervention phase (Week 4) |
|
|
|
| Primary | Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) | The PSS (Cohen et al., 1994) is a 10-item questionnaire measuring the degree to which situations in one's life are appraised as stressful. In particular, it gauges how unpredictable, uncontrollable, and overloaded respondents find their lives. Participants rate each item on a scale of 0 (never) to 4 (very often), and total scores range from 0-40 (0 = least perceived stress, 40 = most perceived stress). | Enrolled participants who completed the Week 4 questionnaires during the appropriate timeframe were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Assessed at the end of the intervention phase (Week 4) |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sham + Mindfulness | Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness Mindfulness: Brightmind mobile mindfulness application sham tVNS: sham transcutaneous vagus nerve stimulation | 0 | 20 | 0 | 20 | 3 | 20 |
| EG002 | Mindfulness Only | Mindfulness: Brightmind mobile mindfulness application | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Control | Control number puzzle task delivered via mobile device Number Puzzle: Control number puzzle task delivered via mobile device | 0 | 20 | 0 | 20 | 0 | 20 |
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