NCT03194113

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2019

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

2.4 years

First QC Date

June 19, 2017

Last Update Submit

February 16, 2021

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

  • PTSD symptom severity

    Clinician Administered Posttraumatic Stress Inventory (CAPS-5) total score

    16 weeks

Secondary Outcomes (8)

  • Depressive symptom severity

    16 weeks

  • Quality of Life score

    16 weeks

  • Responder rate

    16 weeks

  • Dropout rate

    16 weeks

  • Emotion regulation

    16 weeks

  • +3 more secondary outcomes

Study Arms (3)

Trauma-Focused Treatment

ACTIVE COMPARATOR

Weekly sessions of prolonged exposure

Behavioral: Trauma-focused treatment

Emotion Regulation Treatment

ACTIVE COMPARATOR

weekly sessions of emotion regulation and skills training.

Behavioral: Trauma-focused treatmentBehavioral: Emotion regulation training

Intensive Trauma-Focused Treatment

ACTIVE COMPARATOR

prolonged exposure, 3 sessions per week

Behavioral: Intensive Trauma-focused treatment

Interventions

Trauma-focused treatmentBEHAVIORAL

Weekly sessions

Also known as: Cognitive Behavior therapy, Prolonged exposure, Imaginal exposure
Emotion Regulation TreatmentTrauma-Focused Treatment
Emotion regulation trainingBEHAVIORAL

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

Emotion Regulation Treatment
Intensive Trauma-focused treatmentBEHAVIORAL

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

Also known as: Intensive Prolonged Exposure
Intensive Trauma-Focused Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of PTSD according to DSM-5, including at least one specific discrete memory of a traumatic event
  • Multiple traumata related to childhood sexual/physical abuse that occurred before 18 years of age, and committed by a primary caretaker or an authority figure as index event
  • Symptom severity: CAPS score \> 25
  • Sufficient fluency in Dutch to complete the treatment and research protocols

You may not qualify if:

  • Involved in legal procedures concerning admission or stay in The Netherlands
  • Involvement in compensation issues
  • Pregnancy
  • Severe non-suicidal self-injury (NSSI) in the last two months (hospital referral required)
  • Suicidality in the last 2 months
  • Alcohol or drug dependence in last 2 months
  • Cognitive impairment (estimated IQ \< 70)
  • Current psychological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Leiden University - Institute of Psychology

Leiden, South Holland, 2333 AK, Netherlands

Location

PsyQ department of psychotrauma

The Hague, South Holland, 2333 AK, Netherlands

Location

Related Publications (7)

  • Zayfert C, Deviva JC, Becker CB, Pike JL, Gillock KL, Hayes SA. Exposure utilization and completion of cognitive behavioral therapy for PTSD in a "real world" clinical practice. J Trauma Stress. 2005 Dec;18(6):637-45. doi: 10.1002/jts.20072.

    PMID: 16382429BACKGROUND

  • Hendriks, L., & Van Minnen, A. (2014). What to do with treatment failures: Intensive (Prolonged) Exposure treatment for PTSD. Presentation at EABCT Conference The Hague.

    BACKGROUND

  • Ehlers A, Hackmann A, Grey N, Wild J, Liness S, Albert I, Deale A, Stott R, Clark DM. A randomized controlled trial of 7-day intensive and standard weekly cognitive therapy for PTSD and emotion-focused supportive therapy. Am J Psychiatry. 2014 Mar;171(3):294-304. doi: 10.1176/appi.ajp.2013.13040552.

    PMID: 24480899BACKGROUND

  • Cloitre M, Stovall-McClough KC, Nooner K, Zorbas P, Cherry S, Jackson CL, Gan W, Petkova E. Treatment for PTSD related to childhood abuse: a randomized controlled trial. Am J Psychiatry. 2010 Aug;167(8):915-24. doi: 10.1176/appi.ajp.2010.09081247. Epub 2010 Jul 1.

    PMID: 20595411BACKGROUND

  • Cloitre, M., Courtois, C.A., Ford, J.D., Green, B.L., Alexander, P., Briere, J. et al. (2012). The ISTSS Expert Consensus Treatment Guidelines for Complex PTSD in Adults. http://www.istss.org/AM/Template.cmf?Section=ISTSS_Complex_PTSD_Treatment_Guidelines&Template=/CM/ContentDisplay.cfm&ContentID=5185

    BACKGROUND

  • Oprel DAC, Hoeboer CM, Schoorl M, de Kleine RA, Cloitre M, Wigard IG, van Minnen A, van der Does W. Effect of Prolonged Exposure, intensified Prolonged Exposure and STAIR+Prolonged Exposure in patients with PTSD related to childhood abuse: a randomized controlled trial. Eur J Psychotraumatol. 2021 Jan 15;12(1):1851511. doi: 10.1080/20008198.2020.1851511. eCollection 2021.

    PMID: 34630934DERIVED

  • Oprel DAC, Hoeboer CM, Schoorl M, De Kleine RA, Wigard IG, Cloitre M, Van Minnen A, Van der Does W. Improving treatment for patients with childhood abuse related posttraumatic stress disorder (IMPACT study): protocol for a multicenter randomized trial comparing prolonged exposure with intensified prolonged exposure and phase-based treatment. BMC Psychiatry. 2018 Dec 12;18(1):385. doi: 10.1186/s12888-018-1967-5.

    PMID: 30541492DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral TherapyImplosive Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDesensitization, Psychologic

Study Officials

  • Willem Van Der Does, PdhD

    head of department of clinical psychology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 21, 2017

Study Start

December 1, 2016

Primary Completion

April 15, 2019

Study Completion

December 19, 2019

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported from this study may be shared, after deidentification

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Beginning 6 months and ending 5 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

NL(2)