Cost-Effectiveness of Intensive Trauma-Focused Treatment versus Spaced Trauma-Focused Treatment as First-Line Treatment for Post-Traumatic Stress Disorder in Adults With Multiple Trauma Exposure: Randomized Controlled Trial

Conditions: psychische stoornissen, t.w. posttraumatische stressstoornis
Posttraumatic stress disorder
PTSD

Registration Number: NL-OMON56960

Lead Sponsor: ARQ Centrum'45 (Diemen), onderdeel van ARQ Nationaal Psychotrauma Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 186

Inclusion Criteria

(1) 18 years or older;
(2) PTSD diagnosis according to DSM-5 (CAPS-5);
(3) PTSD diagnosis based on >= 2 potentially traumatic events (PTEs);
(4) no prior treatment for PTSD (or less than 8 sessions);
(5) employed (working or on sick leave for <= two years).

Exclusion Criteria

(1) current psychotic disorder, severe alcohol or substance use disorder, high
suicidal intent (MINI-S for DSM-5) with a concrete suicide plan; severe
aggressive behavior that poses danger for others;
(2) insufficient command of the Dutch language to be able to complete the
assessments.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary clinical outcome parameter is the difference in response pattern in<br /><br>terms of PTSD symptom severity on the clinical interview (CAPS-5) from baseline<br /><br>to endpoints between experimental and control conditions. Main outcome<br /><br>parameters for cost-effectiveness are the difference in health-related quality<br /><br>of life (EQ-5D-5L) and costs from a societal perspective (TiC-P) from baseline<br /><br>to endpoints between the experimental and control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Symptom complexity (defined as dissociative symptoms, moral injury, complex<br /><br>PTSD symptoms, and comorbid personality traits), comorbidity (depression,<br /><br>anxiety), verbal memory, experiential avoidance, and social support.</p><br>