This open-label pilot study will evaluate the feasibility, safety, tolerability, and preliminary clinical outcomes of adding intermittent theta-burst stimulation (iTBS) to Eye Movement Desensitization and Reprocessing (EMDR) therapy in adults with post-traumatic stress disorder (PTSD), who show insufficient improvement after an initial course of EMDR.
Participants will receive weekly EMDR therapy. After seven EMDR sessions, treatment response will be assessed using the Clinical Global Impression-Improvement scale (CGI-I). Participants with insufficient response will receive add-on iTBS targeted to the right dorsolateral prefrontal cortex (DLPFC) for four weeks while continuing EMDR. Feasibility outcomes include adherence, treatment completion, and dropout rates. Clinical outcomes will include clinician-rated and self-reported measures of PTSD symptoms, depressive symptoms, well-being, and adverse events.
Age 18-70 years
ICD-10 criteria for PTSD (F43.1)
A minimum total score of 4 (moderately ill) on the Clinical Global Impression-Severity (CGI-S)
Likely to be able to complete trial participation (16 weeks) without modifications to psychopharmacological treatment, as per the referring doctor's or psychologist's assessment
Organic mental disorders (F0)
Currently fulfills the criteria of Active psychoactive substance use or dependence (F1)
Schizophrenia, schizotypal and delusional disorders (F2), manic episode (F30), or bipolar affective disorder (F31); iv) Mental retardation (estimated IQ <70, as per the referring doctor's or psychologist's assessment)
Active suicidality
Aarhus University Hospital
Lead sponsor
Viborg Regional Hospital
Collaborator
Regionshospitalet Horsens
Collaborator