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Completed

NCT Number: NCT03194113

Improving PTSD Treatments for Adults With Childhood Trauma

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University - Institute of Psychology, Leiden, South Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma-focused treatment

Behavioral

Weekly sessions

Other names: Cognitive Behavior therapy, Prolonged exposure, Imaginal exposure

emotion regulation training

Behavioral

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

Intensive Trauma-focused treatment

Behavioral

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

Other names: Intensive Prolonged Exposure

Primary outcomes

  1. PTSD symptom severity

    Time frame: 16 weeks

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

Secondary outcomes

  1. Depressive symptom severity

    Time frame: 16 weeks

    total score on Inventory of Depressive Symptomatology (IDS)

  2. Quality of Life score

    Time frame: 16 weeks

    EQ5D5L total score

  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)

Sponsors and collaborators

Lead sponsor

Leiden University

Other

Collaborators

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

Registry information

Acronym: IMPACT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2017
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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