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Improving PTSD Treatments for Adults With Childhood Trauma (IMPACT)

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ClinicalTrials.gov Identifier: NCT03194113
Recruitment Status : Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
Radboud University
PsyQ
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Willem Van der Does, Leiden University Medical Center

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.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: Trauma-focused treatment Behavioral: Emotion regulation training Behavioral: Intensive Trauma-focused treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving PTSD Treatments for Adults With Childhood Trauma
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : March 19, 2019
Estimated Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine


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 Name: Intensive Prolonged Exposure




Primary Outcome Measures :
  1. PTSD symptom severity [ Time Frame: 16 weeks ]
    total score on Clinician Administered Posttraumatic Stress Inventory (CAPS)


Secondary Outcome Measures :
  1. Depressive symptom severity [ Time Frame: 16 weeks ]
    total score on Inventory of Depressive Symptomatology (IDS)

  2. Quality of life [ Time Frame: 16 weeks ]
    Score on EQ5D5L

  3. Responder rate [ Time Frame: 16 weeks ]
    Meeting pre-defined criteria for remission

  4. Dropout rate [ Time Frame: 16 weeks ]
    premature termination of treatment by patient

  5. Emotion regulation [ Time Frame: 16 weeks ]
    ICD-11 Trauma Questionnaire and Difficulties in Emotion Regulation Scale (DERS)

  6. Self-reported PTSD symptoms [ Time Frame: 16 weeks ]
    Post-traumatic Stress Disorder Checklist (PCL-5)

  7. Interpersonal difficulties [ Time Frame: 16 weeks ]
    ICD-11 Trauma Questionnaire and Inventory of Interpersonal Problems (IIP)

  8. Self-concept [ Time Frame: 16 weeks ]
    ICD-11 Trauma Questionnaire and Rosenberg self-esteem scale (RSS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194113


Locations
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Netherlands
Leiden University - Institute of Psychology
Leiden, Zuid-Holland, Netherlands, 2333 AK
PsyQ department of psychotrauma
The Hague, Zuid-Holland, Netherlands, 2333 AK
Sponsors and Collaborators
Leiden University Medical Center
Radboud University
PsyQ
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Study Chair: Willem Van Der Does, PdhD head of department of clinical psychology

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Willem Van der Does, Professor of Clinical Psychology, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03194113     History of Changes
Other Study ID Numbers: P16-144
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders