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The effects of transcutaneous vagus nerve stimulation on perseverative cognitions in daily life.

The effects of transcutaneous vagus nerve stimulation on perseverative cognitions in daily life. - tVNS and worry in daily life

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43119
Enrollment
96
Registered
2017-03-30
Start date
2018-06-04
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

piekerklachten perseverative cognition

Interventions

Stimulation of the auricular branch of the vagus nerve via the concha of the left ear, or stimulation of the earlobe in the control condition. The stimulation will consist of a constant current of 0

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants must be aged 18-65 years and score higher than 62 on the Penn State Worry Questionnaire (PSWQ), a questionnaire designed to assess worry as a behavioural trait. As described by Behar et al (2003), a cut-off score of 62 on the PSWQ will allow for a highly sensitive and selective selection of chronic worriers when assessing an advertised-for population. Participants can only participate in this study if they have a smartphone on which they can download the app which will be used to prompt participants to answer the daily questions.

Exclusion criteria

Exclusion criteria: Exclusion criteria for this study are based on the study by Kreuzer and colleagues (2012). As such, participants will be excluded from participating in the proposed study if they are diagnosed with a neurological or cardiac disease, and if the participant does not have a history of alcohol or drug abuse. Participants will be excluded from participating in this study if they use other psychological or pharmacological interventions at the start of or during the study. Additionally, participants will be excluded if they can*t read and comprehend Dutch language, and if they are unable to give informed consent. Finally, participants are excluded from participating in this study if they indicate that the stimulation is intolerable.

Design outcomes

Primary

MeasureTime frame
The daily ambulatory assessment of perseverative cognitions is the main study parameter of this study.

Secondary

MeasureTime frame
We are interested in the effects of tVNS on neurophysiological underpinnings of worry. These secondary study parameters will be tested during the psychophysiological assessments, which are scheduled four times over the course of the study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)