Stress and Sleep Study

Not Applicable

Completed

Conditions: Stress, Psychological
Sleep
Mindfulness
Vagus Nerve Stimulation
Transcutaneous Electric Nerve Stimulation

Interventions: Device: tVNS
Other: Number Puzzle
Behavioral: Mindfulness
Device: sham tVNS

Registration Number: NCT05218109

Lead Sponsor: University of Florida

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 76

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tVNS + mindfulness	tVNS	Transcutaneous vagus nerve stimulation plus behavioral: mindfulness
tVNS + mindfulness	Mindfulness	Transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Mindfulness only	Mindfulness	-
Sham + mindfulness	Mindfulness	Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness
Control	Number Puzzle	Control number puzzle task delivered via mobile device
Sham + mindfulness	sham tVNS	Sham transcutaneous vagus nerve stimulation plus behavioral: mindfulness

Primary Outcome Measures

Name	Time	Method
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).
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).