Optimizing exposure therapy for Posttraumatic Stress Disorder

Phase 3

Recruiting

Conditions: PTSD
trauma-related symptoms
10002861

Registration Number: NL-OMON54936

Lead Sponsor: niversiteit Leiden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

A. Satisfying DSM-5 defined criteria for Post-Traumatic Stress Disorder
B. One specific memory related to the index trauma
C. Age between 18 and 70 years

Exclusion Criteria

A. Entry of patients with other psychiatric disorders will be permitted in
order to increase accrual of a clinically relevant sample; however, in cases
where PTSD is not judged to be the predominant disorder, participants will not
be eligible.
B. Current psychotherapeutic trauma-focused treatment (e.g. exposure; EMDR)
C. Patients with significant suicidal ideations or who have enacted suicidal
behaviors within 6 months prior to intake will be excluded from participation.
D. Mental retardation
E. Substance or alcohol dependence
F. Somatic illness that interfere with exposure interventions or planned
assessments (e.g. cardiac conditions)
G. Pregnancy
H. Participants that use psychotropic medication will not be excluded but have
to be on a stable dose for at least 6 weeks prior to enrollment.
I. Participants that cannot commit to refraining from using sedative
medication/alcohol on the days of the intervention and testing.
J. Insufficient ability to speak and write Dutch

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome will be change from baseline to one week follow-up in<br /><br>subjective fear (i.e. Subjective Units of Distress; SUDs) and physiological<br /><br>fear responses (i.e. heart rate and skin conductance) during a personalized<br /><br>trauma-script. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study outcomes will be change from baseline to one week follow-up in:<br /><br>• Avoidance behavior<br /><br>• Self-reported PTSD symptoms over the past week (with the PCL-5).<br /><br><br /><br>Long-term effect of the intervention on symptoms (i.e. PTSD symptoms) will be<br /><br>explored at the three month follow-up (T4). </p><br>