TMR-TRAUMA

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

•PTSD diagnosis according to DSM-5 criteria as assessed with the CAPS-5

•PTSD as primary diagnosis

Exclusion Criteria

•Current bipolar disorder, psychotic disorder, alcohol orsubstance use disorder (moderate and severe forms) as assessed with the M.I.N.I. International Neuropsychiatric Interview. Note comorbid depressive or anxiety disorders will be allowed if PTSD is present as diagnosis.
•Impossibility to isolate a circumscribed traumatic memory that can be used for the audioscript and for target selection in EMDR.
•Reactivation of the traumatic memory that is used for the audioscript and for target selection in EMDR, leads to severe dissociative complaints/signs”
•Not speaking/understanding Dutch sufficiently
•Active suicidal ideation
•Major head trauma with co-occurring loss of consciousness in the recent past
•(Neurological) disorder of the central nervous system, current or in history
•MRI contraindications such as metal implants, claustrophobia, pregnancy
•Use of psychotropic medication (other than benzodiazepines or other sleep medication), except when on a stable dose for at least 6 weeks (after start or alteration of dosage). Use of benzodiazepines or other sleep medication in the period of 1 week prior to study until end of study (Day 10).
•Use of recreational drugs over the entire study period (Day -7 to Day 10).
•Use of alcohol during Day -7, Day 1, Night 1, Day 2, Night 2, Day 3 and Day 10.
•Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timeline travel)
•A sleep window outside 10 pm and 10 am
•Sleep walking or REM sleep behaviour disorder

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following primary study parameters will be assessed pre- and post TMR:<br>1. Subjective (e.g. ratings of distress, vividness and emotionality) and physiological (heart rate and salivary cortisol) indexes of fear and arousal related to the targeted, traumatic memory as probed during a script-driven recall and imagery procedure (symptom provocation task);<br>2. Overall PTSD symptom level;<br>3. Number of intrusions (and related level of distress) of the targeted traumatic memory;<br>4. Brain activation and functional connectivity patterns as measured with fMRI during a script-driven recall and imagery task. <br><br>

Secondary Outcome Measures

Name	Time	Method
The following secundary study parameters will be assessed 1 week (or several days) before and during intervention to test their association with the TMR effect: <br>- Divers sleepparameters such as subjective and objective sleep quality, percentage of time spent in (non-)REM sleep, number and density of sleep spindles and spectral power in the theta, delta and sigma range of the respective sleep phases.<br><br>The following secundary study parameters will be assessed one week before intervention and 6 months thereafter:<br>- Overall PTSD symptom level