The current project investigates whether ILT-based exposure (strategies and techniques based on insights from ILT) leads to symptom reduction and is an acceptable treatment (for both patients and therapists). Additionally, we will examine whether…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Posttraumatic stress disorder (PTSD) is a disruptive disorder, with large
psychological, social and economic impact. Exposure therapy is a first-line
treatment for PTSD. Although it has proven to be an effective treatment for
PTSD, 50 percent of people remain symptomatic after treatment. Extinction
learning is thought to be the most important mechanism of action of exposure
therapy. Extinction is based on the learning of non-threat inhibitory
associations. Pre-clinical studies have established strategies to enhance
inhibitory learning and thereby improve treatment effects. These strategies are
summarized within Inhibitory Learning Theory (ILT). These strategies concern A)
focus on expectation falsification; B) focus on distress tolerance; C)
increasing variability. A combination of these strategies during exposure has
not been studied before. in addition, there is stull much unclear about the
(specific) mechanisms of change of ILT-based exposure and the comparability
with the other variant of exposure therapy, which is focused more on distress
reduction (habituation based exposure).
Study objective
The current project investigates whether ILT-based exposure (strategies and
techniques based on insights from ILT) leads to symptom reduction and is an
acceptable treatment (for both patients and therapists). Additionally, we will
examine whether ILT-based exposure results in a reduction in the proposed
mechanisms of change (expectancy violation and increased distress tolerance)
and whether these are specific to ILT-based exposure.
Study design
We will use a randomized direct sequential replication single-case ABC phase
design, wherein 16 participants will be randomly allocated to either 12
sessions of inhibitory learning theory (ILT)-based exposure or standard
(habituation-based; HAB) exposure. Moreover, the length of the baseline period
will be randomized.
The study consists of several phases.
Phase A: Multiple Baseline
Participants conduct daily diary measurements during a baseline period. The
length of the baseline is randomized between 12 and 18 days.
Phase B: Intervention
Consisting of 4 weeks of exposure therapy (3 sessions of 90 minutes per week).
During this phase, participants will perform daily diary measurements.
Participants will also complete daily measurements two weeks after their last
treatment session.
Phase C: 3-Month Follow-Up
Participants will conduct daily diary measurements for two weeks. After this
two-week period, participants will have a final feedback session with their
therapist.
Measurements:
Assessments (including questionnaires and clinical interviews) will be
conducted at baseline (T0), post-treatment (T1), and 3-month follow-up (T2).
Intervention
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 exposure; 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).
Study burden and risks
Participants commit to being present at three research visits scheduled, 12
sessions of exposure therapy and filling out daily measures. Participants will
spend max 12 hours in total on research-related assessments. All participants
will receive exposure therapy for PTSD, which is an evidence-based guideline
intervention for PTSD. There are no specific risks related to this treatment.
Wassenaarseweg 52
Leiden 2333AK
NL
Wassenaarseweg 52
Leiden 2333AK
NL
Listed location countries
Age
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
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 < 80)
G. Severe substance use disorder
H. Somatic illness that interfere with exposure interventions or planned
assessments (e.g. cardiac conditions)
I. Pregnancy
J. Participants that use psychotropic medication will not be excluded but have
to be on a stable dose for at least 6 weeks prior to enrollment.
K. Participants that cannot commit to refraining from using sedative
medication/alcohol on the days of the intervention and testing.
L. Insufficient ability to speak and write Dutch
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83302.058.22 |