anxiety disorder insomnia
Conditions
Interventions
Participants will be administered a one-time dose of Atomoxetine (40 mg),
Nebivolol (5 mg), Daridorexant (25 mg), Clonidine (50 mcg), and placebo on
separate nights.
Sponsors
Nederlands Herseninstituut
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a volunteer must meet the two inclusion criteria of an age of 18 years or older and the capability of completing online questionnaires and diaries in the Dutch language. To include the severity of insomnia and anxiety as covariates in our analysis, we will assess the Insomnia Severity Index (ISI; Morin et al., 2011) and the Generalized Anxiety Disorder Questionnaire (GAD-7; Williams, 2014) scores of interested volunteers. These scores will not affect potential inclusion. Volunteers will undergo formal diagnostic procedures according to the DSM-5 (M.I.N.I.; Sheehan et al., 1998) for descriptive purposes only. Meeting the criteria of a diagnosis is not an inclusion criterion.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • other relevant treatment for ASRD or ID at the time of study - either pharmacologically or with cognitive behavioral therapy (CBT) • diagnosis of mental disorders other than ASRD or ID (co-occurring depression is allowed). • use of psychotropic medication • history of cardiovascular diseases • heart problems among first-degree relatives • HR 120 (bpm) • BP 170/100 (systolic/diastolic mmHg) • diabetes • liver or kidney diseases • hyperactive production of thyroid hormones • epilepsy • any medication contra-indicative of the use of Atomexatine, Nebivolol, Clonidine, or Daridorexant (as described in the Summary of Product Characteristics) • pregnancy • breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the overnight resolution of recent emotional distress (the karaoke task) as measured by a subjective question (how embarrassed do you feel by this fragment), as well as by heart rate derived from electrocardiography. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will include the other autonomic responses on the karaoke task: galvanic skin responses, blushing response and facial electromyography, as well as subjective ratings of valence and arousal. The overnight resolution of long-lived distress (autobiographical memory task) will also be used as secondary study parameter, including the same autonomic and subjective indices as the karaoke task. The assessments will quantify distress elicited by repeated exposure to a relived embarrassing shameful experience from the distant past, as successfully used by us and others. Lastly, we will exploratively create an individualized stress response, defined by the strongest objective stress response during the karaoke-task in the evening (i.e. the physiology measurement with the largest change between the karaoke-task and the baseline per participant). With this approach we can account for the possibility that shame will be expressed in a different physical manner for different participants. Other study parameters are autonomic resting state features (electrocardiogram, galvanic skin responses, blushing response and facial expressions) and features derived from the nightly electroencephalography (EEG) recording, specifically regarding REM sleep. | — |
Countries
Netherlands
Contacts
Public ContactL Rösler
Nederlands Herseninstituut
Outcome results
None listed