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First-Line Intervention for PTSD - Intensive Treatment (FLIP-IT)

A

ARQ National Psychotrauma Centre

Status

Enrolling

Conditions

PTSD - Post Traumatic Stress Disorder

Treatments

Behavioral: Treatment as usual
Behavioral: Intensive Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06700590
10390092110006 (Other Grant/Funding Number)
NL86057.018.24

Details and patient eligibility

About

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

Enrollment

186 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

186 participants in 2 patient groups

massed/intensive treatment
Experimental group
Treatment:
Behavioral: Intensive Treatment
spaced/weekly treatment
Active Comparator group
Treatment:
Behavioral: Treatment as usual

Trial contacts and locations

4

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Central trial contact

Mirjam Mink-Nijdam, PhD; Bram Kemmere, Msc.

Data sourced from clinicaltrials.gov

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