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TMR-TRAUMA

Targeted Memory Reactivation to augment TRAUMA therapy during sleep (TMR-TRAUMA study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28871
Enrollment
48
Registered
2017-08-16
Start date
2018-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder/PTSD (post-traumatische stress stoornis/PTSS) Targeted memory reactivation/TMR

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 treatme

Sponsors

VU Medical Center and GGZ inGeest
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • Current bipolar disorder, psychotic disorder, alcohol or substance 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

Design outcomes

Primary

MeasureTime 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 recall and imagery task.

Secondary

MeasureTime frame
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: - 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 assessed one week before intervention and 6 months thereafter: - Overall PTSD symptom level

Contacts

Public ContactH.J.F. (Hein) van Marle

Amsterdam UMC, locatie VUmc. GGZ inGeest

h.marle@vumc.nl020-7885000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)