First-Line Intervention for PTSD - Intensive Treatment

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

Conditions

• PTSD - Post Traumatic Stress Disorder

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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

Sponsors & Collaborators

• Rijksuniversiteit Groningen

  collaborator UNKNOWN

• Psychotraumacentrum Haarlem

  collaborator UNKNOWN

• ARQ IVP BV

  collaborator UNKNOWN

• Militaire GGZ

  collaborator UNKNOWN

• Psy-zo BV

  collaborator UNKNOWN

• Erasmus University Rotterdam

  collaborator OTHER

• ARQ National Psychotrauma Centre

  lead OTHER

Principal Investigators

• Mirjam Mink-Nijdam, PhD · ARQ National Psychotrauma Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-21

Primary Completion

2028-04-01

Completion

2028-07-01

Countries

• Netherlands

Study Locations