Post-traumatic stress disorder PTSD
Conditions
Interventions
Patients 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 treat
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 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 imagery task. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secundary study parameters will be obtained during 1 week (or several days) before and during intervention to test their association with the TMR effect: - 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. The following secundary study parameters will be obtained 1 day before intervention and compared between PTSD patients and trauma controls: - Brain activation patterns and functional connectivity patterns as measured with fMRI during the script-driven imagery task. The following secundary study parameters will be obtained during intervention and compared between PTSD patients (in the No reactivation group) and trauma controls: - Divers sleepparameters as mentioned above. | — |
Countries
Netherlands
Outcome results
None listed