Comparing Intensive and Weekly Trauma-Focused Treatments for Adults with PTSD from Multiple Traumas
Led by ARQ National Psychotrauma Centre · Updated on 2025-03-03
186
Participants Needed
4
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether an intensive treatment program can effectively reduce symptoms of post-traumatic stress disorder PTSD in adults receiving treatment for the first time, while also assessing its societal cost compared to standard weekly treatment. The study focuses on adults diagnosed with PTSD stemming from multiple traumatic events and aims to understand if the intensive approach offers advantages in symptom reduction and cost-effectiveness.
Participants will be randomly assigned to one of two groups an intensive treatment group or a standard weekly treatment group. The intensive program includes two preparatory weekly sessions followed by five days of twice-daily sessions over one or two weeks, combining prolonged exposure and eye movement desensitization and reprocessing therapies, with two closing sessions for integration and prevention planning. The standard treatment involves weekly sessions over 13 to 16 weeks using various evidence-based therapies recommended by Dutch guidelines. Both treatments total 800 minutes of therapy, with adherence closely monitored.
Throughout the study, participants will complete questionnaires and interviews at five points over nine months to assess PTSD symptoms, quality of life, mental health, treatment satisfaction, and potential harms. Key outcome measures include the Clinician Administered PTSD Scale for DSM-5 and assessments of cost-effectiveness. The study will also evaluate secondary outcomes such as anxiety, depression, moral injury, dissociative symptoms, and cognitive function. The follow-up schedule allows researchers to monitor both immediate and longer-term effects of the treatments.
CONDITIONS
Brief Title
First-Line Intervention for PTSD - Intensive Treatment
Research Team
M
Mirjam Mink-Nijdam, PhD
B
Bram Kemmere, Msc.
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PTSD caused by two or more potentially traumatic events
Seeking first-time treatment for PTSD or have received fewer than 8 sessions
Employed or on sick leave for less than two years
You will not qualify if you...
Current psychotic disorder
Severe alcohol or substance use disorder
High suicidal intent with concrete suicide plan
Severe aggressive behavior posing danger to others
Insufficient command of Dutch language to complete assessments as determined by clinical judgment at intake
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 to 16 weeks depending on treatment assignment
Participants receive either intensive trauma-focused behavioral therapy involving preparatory sessions followed by five days of twice-daily sessions with prolonged exposure and eye movement desensitization and reprocessing, or spaced weekly trauma-focused behavioral therapy over several weeks using evidence-based modalities according to Dutch guidelines.
Multiple visits weekly during treatment period
Follow-up
Duration - Up to 9 months after treatment ends
Participants are monitored with assessments for symptoms, quality of life, and treatment effects at 6 and 9 months after treatment completion.
Visits at 6 months and 9 months post-treatment
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Cost-effectiveness of massed versus spaced trauma-focused treatment as first-line treatment for post-traumatic stress disorder in adults with multiple trauma exposure: protocol for a single-blind non-inferiority randomised controlled trial.
Bram Kemmere, Ytje T van Pelt, Miriam J J Lommen...