AzTrials
AzTrials

Post Traumatic Stress DisorderIMPACTNCT03194113

Improving PTSD Treatments for Adults With Childhood Trauma

A study testing Trauma-focused treatment, Emotion regulation training and Intensive Trauma-focused treatment in people with Post Traumatic Stress Disorder, run by Leiden University at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Post Traumatic Stress Disorder
What is being tested?
Trauma-focused treatment, Emotion regulation training and Intensive Trauma-focused treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesNetherlands
Study dates
1 Dec 2016to 19 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Cognitive impairment (estimated IQ < 70)
  • Changes in psychotropic medication in the two months prior to inclusion
  • Current psychological treatment

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Leiden University - Institute of Psychology

    Leiden, South Holland, 2333 AK

  • PsyQ department of psychotrauma

    The Hague, South Holland, 2333 AK

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
Trauma-focused treatment, Emotion regulation training, Intensive Trauma-focused treatment
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-focused treatmentBehavioural

    Also called Cognitive Behavior therapy, Prolonged exposure, Imaginal exposure

    Weekly sessions

  • Emotion regulation trainingBehavioural

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

  • Intensive Trauma-focused treatmentBehavioural

    Also called Intensive Prolonged Exposure

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

Study groups in NCT03194113
Study groupRoleWhat they receive
Trauma-Focused TreatmentActive comparatorWeekly sessions of prolonged exposure
Receives: Behavioral: Trauma-focused treatment
Emotion Regulation TreatmentActive comparatorweekly sessions of emotion regulation and skills training.
Receives: Behavioral: Trauma-focused treatment; Behavioral: Emotion regulation training
Intensive Trauma-Focused TreatmentActive comparatorprolonged exposure, 3 sessions per week
Receives: Behavioral: Intensive Trauma-focused treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PTSD symptom severity

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

    Measured: 16 weeks

Secondary outcomes (8)

  1. Depressive symptom severity

    total score on Inventory of Depressive Symptomatology (IDS)

    Measured: 16 weeks

  2. Quality of Life score

    EQ5D5L total score

    Measured: 16 weeks

  3. Responder rate

    Meeting pre-defined criteria for remission

    Measured: 16 weeks

  4. Dropout rate

    premature termination of treatment by patient

    Measured: 16 weeks

  5. Emotion regulation

    ICD-11 Trauma Questionnaire and Difficulties in Emotion Regulation Scale (DERS)

    Measured: 16 weeks

  6. Self-reported PTSD symptoms

    Post-traumatic Stress Disorder Checklist (PCL-5)

    Measured: 16 weeks

  7. Interpersonal difficulties

    ICD-11 Trauma Questionnaire and Inventory of Interpersonal Problems (IIP)

    Measured: 16 weeks

  8. Self-concept

    ICD-11 Trauma Questionnaire and Rosenberg self-esteem scale (RSS)

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2017
  2. Study start1 Dec 2016
  3. Primary completion15 Apr 2019
  4. Study completion19 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03194113
Sponsor's protocol ID
P16-144
Acronym
IMPACT
Status last verified
Feb 2021
First submitted
19 Jun 2017
Last updated
18 Feb 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Individual participant data that underlie the results reported from this study may be shared, after deidentification

Publications

  • 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.

    PubMed 16382429

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

  • 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.

    PubMed 24480899

  • 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.

    PubMed 20595411

  • 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

  • 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.

    PubMed 34630934

  • 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.

    PubMed 30541492

Questions about this trial

What is this clinical trial studying?

A study testing Trauma-focused treatment, Emotion regulation training and Intensive Trauma-focused treatment in people with Post Traumatic Stress Disorder, run by Leiden University at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD symptom severity (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194113, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in