Brainwave Entrainment and Stimulatio

Conditions: trauma- and stressor-related disorder
anxiety disorder
10002861

Registration Number: NL-OMON56492

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 62

Inclusion Criteria

- Age: 18 years or older
- People with uniformed professions or post-active military veterans
- Treatment with protocolized exposure-based therapy sessions for anxiety
disorders or trauma- and stressor-related disorders (according to the
Diagnostic and Statistical Manual of Mental Disorders, or DSM-5, criteria),
e.g.
o Cognitive behavioural therapy with exposure, among which prolonged exposure
(PE)
o Narrative exposure therapy (NET)
o Eye Movement Desensitization and Reprocessing (EMDR) therapy
- Willingness and ability to understand the nature and content of the study, to
participate and to comply with the study requirements
- Willingness and ability to give written informed consent
- Provide written informed consent

Exclusion Criteria

- Large metal or ferromagnetic objects in or around the head area, such as
electronic hearing devices, cochlear implants, deep brain stimulators, or metal
fragments near the skull (except for a dental wire).
- Opened skull or trepanation
- Pacemaker or neurostimulator
- Medication pump
- Epilepsy or family history of epilepsy
- Severe neurological condition or (a history of) brain damage
- Severe psychiatric condition comorbidity (e.g. schizophrenia, addiction)
- Skin damage or diseases around the intended tACS electrode sites (e.g.
psoriasis, eczema)
- Concurrent or recent (within previous month) neuromodulation /
neurostimulation (e.g., tDCS, TMS) treatment or study
- Pregnancy or possible pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the stress response based on heart rate<br /><br>variability (HRV) and subjective units of distress (SUDs) during the<br /><br>exposure-based therapy sessions and subjective anxiety symptoms after the<br /><br>exposure-based therapy sessions. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are PTSD symptom severity and the influence of<br /><br>various baseline measures: resting-state heart rate variability, theta<br /><br>electroencephalography (EEG) activity, emotional working memory, stress hormone<br /><br>response, sleep quality and various mental health variables.</p><br>