CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Trauma-focused treatment +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03194113
NCT03194113N/ACompleted
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Improving PTSD Treatments for Adults With Childhood Trauma

Leiden University·interventional·Posted Jun 21, 2017·Updated Feb 18, 2021

In Brief

A clinical study evaluating Trauma-focused treatment, Emotion regulation training, and 1 other intervention for Post Traumatic Stress Disorder. Completed, enrolled 150 participants across 2 sites.

Detailed Summary

The aim of this project is to investigate the effectiveness of phase-based trauma-focused therapy (PBT) and intensive trauma-focused therapy (I-TFT) for adult patients with PTSD related to childhood abuse. We will carry out a RCT, randomizing 150 patients to receive either standard TFT, PBT or i-TFT. The effects will be assessed at two endpoints of treatment (4, 8 and 16 weeks) and after a 6 and 12 months follow-up in an intention-to-treat analysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Traumatic Stress Disorder
CountriesNetherlands
CollaboratorsRadboud University Medical Center, PsyQ, ZonMw: The Netherlands Organisation for Health Research and Development

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartDec 1, 2016
Primary CompletionApr 15, 2019
Study CompletionDec 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.0 years ago

Interventions

Trauma-focused treatmentbehavioral

Weekly sessions

Emotion regulation trainingbehavioral

Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment

Intensive Trauma-focused treatmentbehavioral

Intensive version (3 sessions per week) of Trauma-focused treatment