anxiety disorder evoked by a severe traumatic event
Conditions
Interventions
Obermann et
al., 2011) and are based on a large multi-center study (O*Reardon et al., 2007)
as well as meta-analyses (see for example Schutter et al., 2009). Firstly, the
resting motor threshold (r
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Based on cut-off scores and in line with previous studies, we will include 20 patients with a PTSD (minimum severity score of 50 on the the Clinician-Administered PTSD Scale, CAPS-1; Blake et al., 1995). All patients will receive intensive exposure therapy as part of their standard clinical treatment at the Centre of Anxiety Disorder in Overwaal. If patients reveal a suboptimal outcome and still have a minimum severity score of 50* as measured by clinician rated and self-rating lists- they will be offered to participate in the rTMS trial if they are eligible. Their standard treatment will be continued but monitored.
Exclusion criteria
Exclusion criteria: With regard to transcranial brain stimulation * Epilepsy, convulsion or seizure (TMS) * Serious head trauma or brain surgery * Large or ferromagnetic metal parts in the head (except for a dental wire) * Implanted cardiac pacemaker or neurostimulator * Pregnancy;With regard to general experimental requirements * History or current presence of any neurologic or psychiatric disease other than PTSD and its affective comorbid disorders (including personality disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures are the change in PTSD symptoms as a function of rTMS/sham rTMS add on treatment. The CAPS-5 will be assessed at pre-treatment and post treatment. The CAPS-1 will provide data on both severity and frequency of PTSD-symptoms, and presence of PTSD diagnosis. The PCL-5 is a 17-item self-report questionnaire that measures the frequency of PTSD symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are potential changes in depressive symptoms as measured by the BDI-II as well as changes in mood as measured by the PANAS before and after each part of the intervention (ie sham or real rTMS-treatment). Dysfunctional trauma-related cognitions are measured by the Dutch version of the Posttraumatic Cognitions Inventory (PTCI; Foa, Ehlers, Clark, Tolin, & Orsillo, 1999; Van Emmerik, Schoorl, Emmelkamp, & Kamphuis, 2006; 36 items), that has good to excellent psychometric properties. In addition, it was found to be sensitive to measure changes during treatment. | — |
Countries
Netherlands
Outcome results
None listed