Improving PTSD Treatments for Adults With Childhood Trauma

NCT03194113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-02-18

No results posted yet for this study

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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

BEHAVIORAL

Trauma-focused treatment

Weekly sessions

BEHAVIORAL

Emotion regulation training

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

BEHAVIORAL

Intensive Trauma-focused treatment

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

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER
  • PsyQ

    collaborator OTHER
  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER
  • Leiden University

    lead OTHER

Principal Investigators

  • Willem Van Der Does, PdhD · head of department of clinical psychology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-01
Primary Completion
2019-04-15
Completion
2019-12-19

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03194113 on ClinicalTrials.gov