Sleep as a window to target traumatic memories
- Conditions
- Post-traumatic stress disorderPTSD10002861
- Registration Number
- NL-OMON55394
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 92
PTSD patients
* PTSD diagnosis according to DSM-5 criteria as assessed with the CAPS-5
* PTSD as primary diagnosis
* 18-65 years of age
* Capability to provide informed consentTrauma controls
* Having experienced a type A-trauma according to DSM-5 criteria as assessed
with the LEC-5 (as part of the CAPS-5).
* No PTSD diagnosis according to DSM-5 criteria as assessed with the CAPS-5
* 18-65 years of age
PTSD patients
* Current bipolar disorder, psychotic disorder, alcohol or substance dependence
as assessed with the M.I.N.I. International Neuropsychiatric Interview. Note
comorbid depressive or anxiety disorders will be allowed if PTSD is the primary
diagnosis.
* Current personality disorder as assessed with the SCID-5-P (preceded by a
screener)
* Active suicidal ideation
* Major head trauma or neurological disease, current or in history
* MRI contraindications such as metal implants, claustrophobia, pregnancy
* Self-reported inability or unease to cease smoking for 24 hours prior to
testing (for salivary cortisol sampling)
* Endocrinological disorders or regular use of corticosteroids (for salivary
cortisol sampling)
* Use psychotropic medication up to 6 weeks pre-study (or in case of
benzodiazepines or other sleep medication 1 week)
* Use of recreational drugs over the entire study period (Day -7 to Day 11).
* Use of alcohol during Day -7, Day 1, Night 1, Day 2, Night 2, Day 3 and Day
11.
* Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timeline
travel)
* A sleep window outside 10 pm and 10 am
Trauma controls
* Any current psychiatric disorder as assessed with the M.I.N.I. International
Neuropsychiatric Interview or known to the patient her/himself.
* Lifetime PTSD 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 <p>The following primary study parameters will be assessed pre- and post TMR:<br /><br>1. Subjective (e.g. ratings of distress, vividness and emotionality) and<br /><br>physiological (heart rate and salivary cortisol) indexes of fear and arousal<br /><br>related to the targeted, traumatic memory as probed during a script-driven<br /><br>recall and imagery procedure (symptom provocation task);<br /><br>2. Overall PTSD symptom level;<br /><br>3. Number of intrusions (and related level of distress) of the targeted<br /><br>traumatic memory;<br /><br>4. Brain activation and functional connectivity patterns as measured with fMRI<br /><br>during a script-driven imagery task. </p><br>
- Secondary Outcome Measures
Name Time Method