PTSD
Conditions
Interventions
All participants will receive a full course of prolonged exposure (PE) therapy
for PTSD (i.e. 12 sessions, 90 minutes each). Participants will be randomly
allocated to receive A) ILT-enhanced exposu
ILT-exposure interventions will
be tailored to 1) maximize expectancy violation
2) increase fear and stimulus
variability
3) increase context variability
or B) Standard (HAB) exposure
In
HAB exposure no specific attention is paid to expectancies and participants
will be repeatedly exposed to the same stimuli (i.e. low variability).
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in either study a participant must meet all of the following criteria: A. Diagnosed with current PTSD and satisfying DSM-5 defined criteria for Post-Traumatic Stress Disorder as established by CAPS-5 interview (primary diagnosis), following repeated trauma B. Three specific memories related to the index trauma C. Self-reported PTSD symptoms above clinical cut-off (i.e. PCL-5 score > 31; Meer et al., 2017) D. Three trauma-related negative cognitions with a high credibility rating (VAS score > 70) E. Ownership of a smart phone and being able to daily complete the digital diary F. Age between 18 and 70 years
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: A. Current trauma-focused treatment (e.g. prolonged exposure; EMDR) B. Prolonged exposure treatment for PTSD in the past (>3 sessions) C. Ongoing traumatization D. Patients with significant suicidal ideations/serious self-injurious behavior or who have enacted suicidal behaviors or serious self-injurious behavior within 3 months prior to intake will be excluded from participation. E. Autism spectrum disorder (established diagnosis by the referring institution) F. Mental retardation (estimated IQ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome will be PTSD symptom decline as assessed by self-report via a diary method (time-series analyses). Participants will complete this diary during baseline (12-18 days), treatment (4 weeks), post treatment (2 weeks) and follow-up (2 weeks). The primary objective is to investigate whether ILT-based exposure leads to a reduction in PTSD symptoms, to examine the feasibility and acceptability of ILT-based exposure, and to gain further insight into the mechanisms of action of both ILT-based exposure and HAB-based exposure. We will examine treatment effects at three levels: i) the construct level (PTSD symptoms and related psychopathology), ii) the target level (symptoms directly targeted by the exposure intervention), and iii) the process level (indicators of processing mechanisms). We will investigate whether ILT-enhanced exposure will lead to symptom improvement, as evidenced by a greater reduction in target symptoms (primary outcome measure). We will track changes over time by using a diary method to assess the change in target symptoms across the different stages of the study (i.e., baseline (A), treatment (B), and follow-up (C)). | — |
Secondary
| Measure | Time frame |
|---|---|
| We will assess and compare changes in fear responses to a personalized trauma-script and clinician rated PTSD symptoms. Assessments will take place at baseline (T0), post-treatment (T1) and follow-up (T2). Additionally, to monitor changes at the process level: We will assess fear levels and expectancies during exposure sessions To gain more insight in the acceptability for patients and therapists, we will conduct interviews. | — |
Countries
Netherlands
Outcome results
None listed