TEMPO trial: Trauma-focused Exposure with Motion for Posttraumatic stress disorder

Recruiting

Conditions: Posttraumatic Stress Disorder
PTSD
10002861

Registration Number: NL-OMON53394

Lead Sponsor: GGZ Drenthe (Assen)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 182

Inclusion Criteria

1) PTSD diagnosis established by the Clinician-Administered PTSD scale for
DSM-5 (CAPS-5)
2) age 18 years or older
3) sufficient mastery of the Dutch language to perform the assessments
4) be able to keep a stable dose of psychotropic medication between four weeks
before entering the trial and until the first follow-up assessment, three
months post treatment (F4).

Exclusion Criteria

1) unable to walk for approximately one hour
2) a high acute risk of suicidality
3) hospitalized in the past three months due to severe psychiatric conditions
(e.g., severe self-injury, acute florid psychotic symptoms or severe eating
disorder
4) report high levels of acute dissociative amnesia (memory gaps) which might
prevent them to store new, corrective information from the trauma-focused
treatment session
5) severe substance use disorder which needs specialized treatment
6) uses substances and cannot adhere to the agreement of not being under the
influence of addictive substances during treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is PTSD severity over time, measured with<br /><br>Clinical-Administered PTSD Scale for DSM-5 (CAPS-5).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are trauma-related avoidance and general avoidance<br /><br>tendencies. Moreover, self-reported PTSD symptoms, depressive- and dissociative<br /><br>symptoms, treatment expectancy and engagement, and heart and respiration rate<br /><br>during VR exposure sessions will be measured.</p><br>