Trauma-focused treatment
BehavioralWeekly sessions
Other names: Cognitive Behavior therapy, Prolonged exposure, Imaginal exposure
NCT Number: NCT03194113
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Leiden University - Institute of Psychology, Leiden, South Holland, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly sessions
Other names: Cognitive Behavior therapy, Prolonged exposure, Imaginal exposure
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 names: Intensive Prolonged Exposure
Time frame: 16 weeks
Clinician Administered Posttraumatic Stress Inventory (CAPS-5) total score
Time frame: 16 weeks
total score on Inventory of Depressive Symptomatology (IDS)
Time frame: 16 weeks
EQ5D5L total score
Time frame: 16 weeks
Meeting pre-defined criteria for remission
Time frame: 16 weeks
premature termination of treatment by patient
Time frame: 16 weeks
ICD-11 Trauma Questionnaire and Difficulties in Emotion Regulation Scale (DERS)
Time frame: 16 weeks
Post-traumatic Stress Disorder Checklist (PCL-5)
Time frame: 16 weeks
ICD-11 Trauma Questionnaire and Inventory of Interpersonal Problems (IIP)
Time frame: 16 weeks
ICD-11 Trauma Questionnaire and Rosenberg self-esteem scale (RSS)
Leiden University
Other
Acronym: IMPACT
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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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