First-Line Intervention for PTSD - Intensive Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Intensive 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.

Treatment 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

Study 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

Primary outcome measure(s)

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5) — At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
  The primary outcome, severity of Post-Traumatic Stress Disorder (PTSD) is assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). CAPS-5 is a comprehensive 20-item clinical interview that assesses both the DSM-5 PTSD diagnostic criteria and the severity of PTSD symptoms. Scores range from 0 to 80, with higher scores denoting greater symptom severity. The CAPS-5 showed high internal consistency and interrater reliability, good test-retest reliability, and good validity. All the assessors are or will be trained to administer the Dutch versions of the CAPS-5. It requires a total of 225 minutes to complete at all measurement points.
• Cost-effectiveness (Quality of life) — At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
  Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. Quality of life will be assessed using the Euro Quality of Life 5 Dimensions (EQ-5D-5L) scale. This scale comprises 14 items categorized into various aspects of health status, rated on a three-point scale.
• Cost-effectiveness (Mental Health Quality of Life Questionnaire) — At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
  Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Mental Health Quality of Life Questionnaire (MHQoL) will be utilized to assess the quality of life among individuals with mental health issues. The MHQoL comprises a descriptive system (the MHQoL-7D) and a visual analog scale (MHQoL-VAS).
• Cost-effectiveness (Treatment inventory of costs) — At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
  Cost-effectiveness is a composite measure of quality of life (physical and mental), and treatment inventory of costs. The Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P) will be utilized to map the costs arising from psychosocial problems in adults. It consists of three components: general questions, questions regarding medical care utilization, and questions related to work.

Trial sites (4)

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