Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Viborg Regional Hospital | OTHER |
| Regionshospitalet Horsens | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by intrusive traumatic memories, avoidance behaviors, negative alterations in cognition and mood, and persistent hyperarousal. Although trauma-focused psychotherapies such as Eye Movement Desensitization and Reprocessing (EMDR) are recommended as first-line treatments, a substantial proportion of patients continue to meet diagnostic criteria for PTSD despite receiving evidence-based psychotherapy.
Intermittent theta-burst stimulation (iTBS), a brief form of repetitive transcranial magnetic stimulation (rTMS), has demonstrated preliminary efficacy in reducing PTSD symptoms and offers practical advantages due to its short treatment duration.
The present study aims to investigate whether iTBS can be feasibly integrated as an adjunctive intervention for patients who do not respond sufficiently to EMDR therapy alone. This is an investigator-initiated, open-label feasibility study conducted within psychiatric services in the Central Denmark Region.
Eligible adults aged 18 to 70 years with a diagnosis of PTSD, who are referred for EMDR treatment, will be enrolled. Participants will receive standardized EMDR therapy consisting of sixteen weekly 90-minute sessions. Following completion of seven EMDR sessions, treatment response will be evaluated using the Clinical Global Impression-Improvement (CGI-I) scale. Participants rated as having insufficient improvement (CGI-I score ≥3) will be offered add-on iTBS.
The iTBS intervention will be delivered to the right DLPFC using a MagPro R30 stimulator and Cool-B70 coil. Treatment will consist of one daily iTBS session administered five days per week over four weeks for a total of 20 sessions. Participants will continue weekly EMDR therapy throughout the iTBS phase and subsequent follow-up period.
The primary objectives are to evaluate the safety, tolerability, and feasibility of the combined EMDR+iTBS intervention. Feasibility outcomes include treatment adherence, treatment completion rates, and dropout rates. Secondary outcomes include adverse events and changes in PTSD symptom severity measured using clinician-rated and self-reported instruments.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMDR with add-on iTBS | Experimental | Participants receive weekly Eye Movement Desensitization and Reprocessing (EMDR) therapy for up to 16 weeks. After seven EMDR sessions, treatment response is assessed using the Clinical Global Impression-Improvement scale (CGI-I). Participants with insufficient response receive adjunctive intermittent theta-burst stimulation (iTBS) to the right dorsolateral prefrontal cortex for 20 sessions over 4 weeks while continuing EMDR. Participants with sufficient response continue EMDR treatment alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Theta-Burst Stimulation (iTBS) | Device | All enrolled participants begin standardized EMDR treatment. Participants who show insufficient clinical improvement after seven EMDR sessions receive adjunctive intermittent theta-burst stimulation (iTBS) while continuing EMDR. Participants who show sufficient improvement continue EMDR alone. |
| Measure | Description | Time Frame |
|---|---|---|
| Drop-out | The primary outcome will be drop-out rates | From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Treatment completion rates | The second primary outcome will be treatment completion rates (number of iTBS treatments received out of the planned 20 treatments) | From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom trajectories | Symptom trajectories, as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Symptom trajectories |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pernille Kølbæk, MD PhD | Contact | 004561397432 | perpet@rm.dk | |
| Ana Lisa Carmo, Psychiatrist | Contact | 0045 61155056 | ANAMAR@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Pernille Kølbæk | Aarhus University Hospital | Study Chair |
| Ana Lisa Carmo | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Symptom trajectories, as measured by the PTSD Checklist for DSM-5 (PCL-5)
| From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Symptom trajectories | Symptom trajectories, as measured by International Trauma Questionnaire (ITQ) | From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Symptom trajectories | Symptom trajectories, as measured by the 6-item self-reported Hamilton Depression Rating Scale (HAM-D6-SR) | From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Adverse event rates | Adverse event rates, measured by means of the Transcranial Magnetic Stimulation Sensory Questionnaire (TMSens_Q) | From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Adverse event rates | Adverse event rates, measured by means of the Aarhus Side Effects Assessment Scale (ASAQ) | Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Changes in mental well-being | Mental well-being as measured by the World Health Organization 5-item well-being scale (WHO-5) | From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) |
| Regional Psychiatry Horsens | Horsens | Denmark |
|
| Regional Psychiatry Central Jutland | Viborg | Denmark |
|
| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided