Improving PTSD Treatments for Adults With Childhood Trauma
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

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.
    

Intervention name(s): Trauma-focused treatment; Emotion regulation training; Intensive Trauma-focused treatment
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Weekly sessions; Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment; Intensive version (3 sessions per week) of Trauma-focused treatment
Other intervention name(s): Cognitive Behavior therapy; Prolonged exposure; Imaginal exposure; Intensive Prolonged Exposure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment