The main objective of the current study is to assess whether tVNS affects perseverative cognition, especially worry, in the daily lives in chronic worriers.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
piekerklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The daily ambulatory assessment of perseverative cognitions is the main study
parameter of this study.
Secondary outcome
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.
Background summary
Perseverative cognition, such as worrying and rumination, lies at the heart of
the pathogenesis and maintenance of stress-related disorders. The currently
available psychological and pharmacological treatments for stress-related
disorders are only moderately effective. The activity of the vagus nerve is
chronically low in chronic worriers. In this exploratory study, we aim to test
whether transcutaneous stimulation of the vagus nerve (tVNS) affects the
frequency and duration of participant*s worries. Non-invasive stimulation of
the vagus nerve seems a promising treatment as the vagus nerve projects onto
emotional brain areas implicated in perseverative cognition.
Study objective
The main objective of the current study is to assess whether tVNS affects
perseverative cognition, especially worry, in the daily lives in chronic
worriers.
Study design
A randomized single blinded controlled trial. Participants* worry behaviour is
assessed over a two-day period using experience sampling methods, where
participants provide ambulatory assessments of the frequency and duration of
their daily worries using their smartphones. During this two-day period,
participants receive either tVNS or sham stimulation.
Intervention
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 0.5mA delivered twice a day
for 30 minutes with a stimulation frequency of 25 Hz and stimulus wavelength of
250µs, active for 30 seconds, followed by a break of 30 seconds.
Study burden and risks
Potential side-effects include itching and a local pain or burning sensation at
the stimulation site. These side-effects often disappear rapidly after stopping
the stimulation. tVNS is not associated with changes in heart rate, heart rate
variability or respiratory rate.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
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 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
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57229.058.16 |