RecruitingNot ApplicableNCT06700590

First-Line Intervention for PTSD - Intensive Treatment

(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

Sponsor

ARQ National Psychotrauma Centre

Enrollment

186 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

PTSD - Post Traumatic Stress Disorder

Summary

The goal of this clinical trial is to learn if an intensive program can treat post-traumatic stress disorder (PTSD) in adults getting treatment for the first time, and whether it has lower societal costs. The main questions it aims to answer are: * Does an intensive program reduce PTSD symptoms? * How expensive is it on a societal level? Researchers will compare the intensive program to the standard weekly treatment to see if the intensive program works to treat PTSD. Participants will: * Get 5 days of intensive treatment in two weeks (with two preparatory and closing sessions), or weekly sessions * Get questionnaires and interviews 5 times in 9 months

Eligibility

Min Age: 18 Years

Inclusion Criteria5

years or older
PTSD diagnosis according to DSM-5 (CAPS-5);
PTSD diagnosis stemming from 2 or more potentially traumatic events (PTEs)
seeking first-time treatment for PTSD (or less than 8 sessions);
employed (working or on sick leave for less than two years)

Exclusion Criteria2

Current psychotic disorder, severe alcohol or substance use disorder, high suicidal intent (MINI-S for DSM-5) and a concrete suicide plan, or severe aggressive behavior that poses danger for others
insufficient command of the Dutch language to be able to complete the assessments. This will be determined through clinical judgment at intake.

Interventions

BEHAVIORALIntensive Treatment

Participants engage in two preparatory sessions once weekly, lasting 50 minutes each, which focus on psychoeducation and case conceptualization. The core treatment consists of five days of twice-daily sessions delivered over one or two weeks. The first session of the day consists of prolonged exposure (PE). The second session consists of eye movement desensitization and reprocessing (EMDR). Both treatments are performed in strict adherence to their respective manualized protocol. Two closing sessions focus on lessons learned, integration and a prevention plan. The treatment in total lasts 6 weeks and contains 800 minutes of treatment. To enhance practicality, treatment rotation is allowed and encouraged. Rigorous checks on treatment adhenrence will be implemented.

BEHAVIORALTreatment as usual

Spaced/weekly treatment consists of a treatment-as-usual condition, increasing the representativeness of the control condition. Treatment duration is 800 minutes, either 13 weeks of 60 minutes (with the last sessions being 80 minutes), or 16 weeks of 50 minutes. All evidence-based treatment modalities of the Dutch guidelines are allowed: PE, EMDR, brief eclectic psychotherapy for PTSD (BEPP), narrative exposure therapy (NET), and imaginary rescripting (ImRs). All have common elements of psychoeducation, imaginal exposure, emotional processing, cognitive restructuring and/or meaning making. Treatment adherence will be monitored throughout the intervention. Therapist rotation is not performed