Stress, Psychological, Sleep, Transcutaneous Electric Nerve Stimulation, Vagus Nerve Stimulation, Mindfulness
Conditions
Brief summary
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.
Interventions
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Undergraduate student (ages 18-30) * Must own a smartphone * Must be able to read and write English
Exclusion criteria
* Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), medical conditions associated with neurological effects (e.g. heart, kidney disease), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) * Pregnancy * History of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices * History of adverse reaction to electrical nerve stimulation * Prescribed sleep medications and/or psychotropic medications * Illicit or prescription drug abuse within the last two months (marijuana or alcohol abuse \>2 weeks out will be acceptable for inclusion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) | Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2 | 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. |
| Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) | Assessed at the end of the intervention phase (Week 4) | 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). |
| Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) | Assessed at the end of the intervention phase (Week 4) | 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). |
Countries
United States
Participant flow
Pre-assignment details
Participants were assigned to study arms/groups pseudo-randomly upon scheduling an intake appointment (prior to enrollment).
Participants by arm
| Arm | Count |
|---|---|
| tVNS + Mindfulness Transcutaneous vagus nerve stimulation plus behavioral: mindfulness
tVNS: transcutaneous vagus nerve stimulation
Mindfulness: Brightmind mobile mindfulness application | 15 |
| Sham + Mindfulness Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Mindfulness: Brightmind mobile mindfulness application
sham tVNS: sham transcutaneous vagus nerve stimulation | 17 |
| Mindfulness Only Mindfulness: Brightmind mobile mindfulness application | 20 |
| Control Control number puzzle task delivered via mobile device
Number Puzzle: Control number puzzle task delivered via mobile device | 20 |
| Total | 72 |
Baseline characteristics
| Characteristic | Total | Control | Mindfulness Only | Sham + Mindfulness | tVNS + Mindfulness |
|---|---|---|---|---|---|
| Age, Continuous | 20.26 years STANDARD_DEVIATION 1.74 | 20.75 years STANDARD_DEVIATION 1.45 | 19.95 years STANDARD_DEVIATION 1.73 | 19.71 years STANDARD_DEVIATION 1.26 | 20.67 years STANDARD_DEVIATION 2.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 9 Participants | 8 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 11 Participants | 12 Participants | 15 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Perceived Stress Scale (PSS) | 15.64 units on a scale STANDARD_DEVIATION 5.95 | 16.35 units on a scale STANDARD_DEVIATION 6 | 14.80 units on a scale STANDARD_DEVIATION 5.15 | 16.47 units on a scale STANDARD_DEVIATION 7.26 | 14.87 units on a scale STANDARD_DEVIATION 5.59 |
| Pittsburg Sleep Quality Index (PSQI) | 8.38 units on a scale STANDARD_DEVIATION 2.83 | 7.25 units on a scale STANDARD_DEVIATION 3 | 8.9 units on a scale STANDARD_DEVIATION 2.61 | 9.29 units on a scale STANDARD_DEVIATION 2.71 | 8.13 units on a scale STANDARD_DEVIATION 2.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 3 Participants | 5 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 4 Participants | 3 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 34 Participants | 10 Participants | 9 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Female | 42 Participants | 10 Participants | 10 Participants | 12 Participants | 10 Participants |
| Sex: Female, Male Male | 30 Participants | 10 Participants | 10 Participants | 5 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 16 | 3 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 16 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: Assessed in the tVNS + mindfulness groups and sham + mindfulness groups at Week 2
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tVNS + Mindfulness | Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) | 4.08 units on a scale | Standard Deviation 0.4 |
| Sham + Mindfulness | Acceptability of the Combined tVNS + Mindfulness Intervention as Assessed by Participant Self-report of Acceptability Using the Acceptability of Intervention Measure (AIM) | 3.37 units on a scale | Standard Deviation 1.15 |
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).
Time frame: Assessed at the end of the intervention phase (Week 4)
Population: Enrolled participants who completed the Week 4 questionnaires during the appropriate timeframe were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tVNS + Mindfulness | Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) | 11.46 units on a scale | Standard Deviation 5.81 |
| Sham + Mindfulness | Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) | 13.36 units on a scale | Standard Deviation 6.34 |
| Mindfulness Only | Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) | 14.47 units on a scale | Standard Deviation 5.58 |
| Control | Perceived Stress as Assessed by Participant Self-report on the Perceived Stress Scale (PSS) | 16.42 units on a scale | Standard Deviation 8.66 |
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).
Time frame: Assessed at the end of the intervention phase (Week 4)
Population: Enrolled participants who completed the Week 4 questionnaires during an appropriate timeframe were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tVNS + Mindfulness | Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) | 6.23 units on a scale | Standard Deviation 2.62 |
| Sham + Mindfulness | Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) | 8.29 units on a scale | Standard Deviation 2.61 |
| Mindfulness Only | Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) | 7.84 units on a scale | Standard Deviation 2.32 |
| Control | Sleep Quality as Assessed by Participant Self-report on the Pittsburgh Sleep Quality Index (PSQI) | 8.21 units on a scale | Standard Deviation 2.78 |