Clinical trial NCT06700590: First-Line Intervention for PTSD - Intensive Treatment
Official title: (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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD - Post Traumatic Stress Disorder
Keywords: intensive treatment
massed treatment
randomized controlled trial
RCT
first time treatment
Lead sponsor: ARQ National Psychotrauma Centre
Sponsor class: OTHER
Collaborators: name: Rijksuniversiteit Groningen
name: Psychotraumacentrum Haarlem
name: ARQ IVP BV
name: Militaire GGZ
name: Psy-zo BV
name: Erasmus University Rotterdam
First posted: 2024-11-22
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 18 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 Criteria:

* 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.

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
measure: Cost-effectiveness (Quality of life)
timeFrame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
measure: Cost-effectiveness (Mental Health Quality of Life Questionnaire)
timeFrame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
measure: Cost-effectiveness (Treatment inventory of costs)
timeFrame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
Secondary outcomes:
measure: International Trauma Questionnaire (ITQ)
timeFrame: At baseline (T0).
measure: Moral Injury Outcome Scale (MIOS)
timeFrame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
measure: Acceptance and Action Questionnaire (AAQ-II)
timeFrame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
measure: Personality Inventory for DSM-5-Brief Form-Adult (PID-5-BF-NL)
timeFrame: At baseline (T0), and at 6 months (T3)
measure: Dissociative Symptoms Assessment (DSS-4)
timeFrame: At baseline (T0), after intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
measure: Crisis Support Scale (CSS)
timeFrame: At baseline (T0), after 6 months (T3)
measure: Verbal Learning and Memory Test (VLGT)
timeFrame: At baseline (T0), after weekly treatment (T2, 17 weeks)
measure: Harms
timeFrame: After intensive treatment (T1, 7 weeks), after weekly treatment (T2, 17 weeks), after 6 months (T3) and 9 months (T4).
measure: Treatment satisfaction
timeFrame: at 7 weeks (T1) and 17 weeks (T2)
Other outcomes:
measure: Mini International Neuropsychiatric Interview - Simplified for DSM-5 (MINI-S)
timeFrame: At baseline (T0).
measure: Life Events Checklist for DSM-5 (LEC-5)
timeFrame: At baseline (T0).
measure: Adverse Childhood Experience International Questionnaire for adults (ACE-IQ)
timeFrame: At baseline (T0).
measure: Hair cortisol
timeFrame: At baseline (T0).
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: At baseline (T0).
Locations:
city: Diemen
country: Netherlands
facility: ARQ IVP
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Psychotraumacentrum Haarlem
state: Noord-Holland
city: Oegstgeest
country: Netherlands
facility: ARQ Centrum'45
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Psy-Zo!
Study officials:
affiliation: ARQ National Psychotrauma Center
name: Mirjam Mink-Nijdam, PhD
role: PRINCIPAL_INVESTIGATOR
References: