Adding rTMS to exposure therapy in PTSD in a placebo-controlled design : a pilot study

Withdrawn

Conditions: anxiety disorder evoked by a severe traumatic event
10002861

Registration Number: NL-OMON47598

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 0

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measures are the change in PTSD symptoms as a function of<br /><br>rTMS/sham rTMS add on treatment. The CAPS-5 will be assessed at pre-treatment<br /><br>and post treatment. The CAPS-1 will provide data on both severity and frequency<br /><br>of PTSD-symptoms, and presence of PTSD diagnosis. The PCL-5 is a 17-item<br /><br>self-report questionnaire that measures the frequency of PTSD symptoms.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures are potential changes in depressive symptoms as<br /><br>measured by the BDI-II as well as changes in mood as measured by the PANAS<br /><br>before and after each part of the intervention (ie sham or real<br /><br>rTMS-treatment). Dysfunctional trauma-related cognitions are measured by the<br /><br>Dutch version of the Posttraumatic Cognitions Inventory (PTCI; Foa, Ehlers,<br /><br>Clark, Tolin, & Orsillo, 1999; Van Emmerik, Schoorl, Emmelkamp, & Kamphuis,<br /><br>2006; 36 items), that has good to excellent psychometric properties. In<br /><br>addition, it was found to be sensitive to measure changes during treatment.</p><br>