Improving PTSD Treatments for Adults With Childhood Trauma (IMPACT)

February 16, 2021 updated by: Willem Van der Does, Leiden University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Dutch treatment guidelines recommend trauma-focused treatment (TFT) for PTSD. In TFT, patients are exposed to trauma reminders that they typically avoid, until their emotional reactions decline. This treatment has been found very effective for some patients but there is much room for improvement, particularly in PTSD related to childhood abuse (CA-PTSD). Symptom exacerbation, non-attendance and dropout rates of up to 40% have been observed in patients with CA-PTSD.

Two alternative treatments have been proposed. Firstly, TFT may be preceded by emotion regulation and interpersonal skills training. This is called phase-based treatment (PBT). The rationale is that patients with CA-PTSD have affect regulation and interpersonal problems that interfere with effective delivery of TFT. These problems are rooted in the detrimental developmental effects of abuse (often by an attachment figure). PBT indeed resulted in more favorable outcomes and fewer dropouts. In international guidelines, PBT was recently recommended as treatment of choice for patients with CA-PTSD and comorbidity.

Another innovative treatment is intensive TFT (i-TFT), which means delivering TFT in 4 instead of 16 weeks. The condensed format enhances learning and prevents the buildup of anticipatory anxiety, which in turn affects the patients' motivation. Patients with CA-PTSD are also characterized by high psychosocial stressors, leading to problems with treatment attendance and compliance. The condensed format may improve motivation, attendance and compliance. I-TFT was recently tested in a case series in patients with CA-PTSD and in a randomized controlled trial (RCT) with patients with adulthood-related PTSD. Both studies had very low dropout rates (0-3%) and fast recovery.

The aim of the current study is to investigate the (cost)effectiveness of two innovative forms of trauma-focused therapy for patients with CA-PTSD: phase-based therapy (emotion regulation skills training followed bij PE) and intensive PE (i-PE). The effects will be assessed post-treatment and after a 6 and 12 months follow-up in an intention-to-treat analysis. Results will be disseminated and included in treatment guidelines. The ultimate goal is to improve quality of care and contribute to treatment innovation for this severely ill target population.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 AK
        • Leiden University - Institute of Psychology
      • The Hague, Zuid-Holland, Netherlands, 2333 AK
        • PsyQ department of psychotrauma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Changes in psychotropic medication in the two months prior to inclusion
  • Current psychological treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Trauma-Focused Treatment
Weekly sessions of prolonged exposure
Behavioral: Trauma-focused treatment
Weekly sessions
Other Names:
  • Cognitive Behavior therapy
  • Prolonged exposure
  • Imaginal exposure
Active Comparator: Emotion Regulation Treatment
weekly sessions of emotion regulation and skills training.
Behavioral: Trauma-focused treatment
Weekly sessions
Other Names:
  • Cognitive Behavior therapy
  • Prolonged exposure
  • Imaginal exposure
Behavioral: Emotion regulation training
Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment
Active Comparator: Intensive Trauma-Focused Treatment
prolonged exposure, 3 sessions per week
Behavioral: Intensive Trauma-focused treatment
Intensive version (3 sessions per week) of Trauma-focused treatment
Other Names:
  • Intensive Prolonged Exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD symptom severity
Time Frame: 16 weeks
Clinician Administered Posttraumatic Stress Inventory (CAPS-5) total score
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptom severity
Time Frame: 16 weeks
total score on Inventory of Depressive Symptomatology (IDS)
16 weeks
Quality of Life score
Time Frame: 16 weeks
EQ5D5L total score
16 weeks
Responder rate
Time Frame: 16 weeks
Meeting pre-defined criteria for remission
16 weeks
Dropout rate
Time Frame: 16 weeks
premature termination of treatment by patient
16 weeks
Emotion regulation
Time Frame: 16 weeks
ICD-11 Trauma Questionnaire and Difficulties in Emotion Regulation Scale (DERS)
16 weeks
Self-reported PTSD symptoms
Time Frame: 16 weeks
Post-traumatic Stress Disorder Checklist (PCL-5)
16 weeks
Interpersonal difficulties
Time Frame: 16 weeks
ICD-11 Trauma Questionnaire and Inventory of Interpersonal Problems (IIP)
16 weeks
Self-concept
Time Frame: 16 weeks
ICD-11 Trauma Questionnaire and Rosenberg self-esteem scale (RSS)
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University

Collaborators

Radboud University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
PsyQ

Investigators

  • Study Chair: Willem Van Der Does, PdhD, head of department of clinical psychology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

April 15, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 19, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16-144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Time Frame

Beginning 6 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Analytic Code

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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