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Sleep off your trauma


- candidate number27752
- NTR NumberNTR6632
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-aug-2017
- Secondary IDs016176130 NWO
- Public TitleSleep off your trauma
- Scientific TitleSleep as a window to target traumatic memories
- ACRONYMSleep and traumatic memories
- hypothesisThe two primary objectives of this study are: 1. To increase therapeutic effectiveness of an eye movement desentization and reprocessing (EMDR) treatment session in patients with post-traumatic stress disorder (PTSD) by reactivating the updated traumatic memory during post-treatment sleep using targeted memory reactivation; and 2. To provide a neural base for this augmented treatment effect by showing a (enhanced) system-level reorganization of the targeted memory trace using functional MRI.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD), Targeted memory reactivation (TMR), EMDR
- Inclusion criteria 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 consent
- Exclusion criteria 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 of psychotropic medication up to 6 weeks pre-study (or in case of benzodiazepines 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2018
- planned closingdate1-jan-2021
- Target number of participants69
- InterventionsPatients will be treated with a single session of EMDR by a certified therapist. EMDR is a first-choice treatment for PTSD, which has been shown to be safe and effective. After successful EMDR treatment, patients will undergo TMR during post-treatment sleep. TMR is a recently described experimental procedure which aims at strengthening memory consolidation processes during sleep by re-administering context cues, such as auditory or olfactory stimuli, that are linked to the targeted memory at awake encoding.
- Primary outcomeThe following primary study parameters will be assessed pre- and post TMR:
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);
2. Overall PTSD symptom level;
3. Number of intrusions (and related level of distress) of the targeted traumatic memory;
4. Brain activation and functional connectivity patterns as measured with fMRI during a script-driven recall and imagery task.
- Secondary outcomeThe following secundary study parameters will be assessed 1 week (or several days) before and during intervention and their effect on TMR tested:
- 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.
- TimepointsTotal participation time will be approximately 22 hours over a 2,5-week time period, consisting of 4 lab visits (including 1 night of polysomnographically-monitored sleep).
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES H.J.F. (Hein) van Marle
- CONTACT for SCIENTIFIC QUERIES H.J.F. (Hein) van Marle
- Sponsor/Initiator VU University Medical Center, GGZ inGeest
- Funding
(Source(s) of Monetary or Material Support)
NWO, division ZonMw
- Publications
- Brief summaryPost-traumatic stress disorder (PTSD) is a severe mental disorder associated with significant personal and societal burden. Traumatic memories are at the core of its pathophysiology, resulting in key-symptoms such as nightmares and flashbacks. Currently, first-choice treatment, consisting of exposure-based psychotherapy, such as eye movement desensitization and reprocessing (EMDR), proves ineffective in half of PTSD-patients. Hence, there is an urgent need to improve treatment. Sleep is crucial in the treatment of traumatic memories. During exposure-based treatment, traumatic memories get reactivated and subsequently re-encoded with lower fear. This treatment effect is then solidified during memory consolidation while asleep when the 'neutralized' memories get integrated in long-term storage, stabilizing them and further reducing their affective charge. Recent advances in basic memory research show that memory consolidation can be significantly enhanced by presenting reminder cues (sounds/scents that were linked to the memory at encoding) during subsequent sleep (targeted memory reactivation (TMR)). Here, we apply these memory reactivation strategies during sleep for the first time in (PTSD) patients to increase therapeutic effectiveness. Using a controlled design, we predict that re-administering auditory cues, that are already part of a specific PTSD treatment during post-treatment sleep, will increase therapeutic outcome. This is measured as reduced subjective and physiological fear in relation to the targeted memory, as well as reduced overall PTSD symptom level. To visualize the underlying transfer of the memory trace to higher-order memory networks, we will obtain functional MRI during scripted recall of the traumatic event pre/post study.
- Main changes (audit trail)
- RECORD16-aug-2017 - 26-aug-2017


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