To test whether maximizing inhibitory learning can improve exposure efficacy for those suffering from PTSD.
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 change from baseline to one week follow-up in
subjective fear (i.e. Subjective Units of Distress; SUDs) and physiological
fear responses (i.e. heart rate and skin conductance) during a personalized
trauma-script.
Secondary outcome
Secondary study outcomes will be change from baseline to one week follow-up in:
• Avoidance behavior
• Self-reported PTSD symptoms over the past week (with the PCL-5).
Long-term effect of the intervention on symptoms (i.e. PTSD symptoms) will be
explored at the three month follow-up (T4).
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). This project examines
ILT-based strategies and techniques to improve exposure treatment outcome in
PTSD.
Study objective
To test whether maximizing inhibitory learning can improve exposure efficacy
for those suffering from PTSD.
Study design
The planned study comprises three separate randomized controlled trial (RCT*s),
with identical study designs and consecutive participant enrollment. Per study,
60 patients suffering from PTSD will be randomly allocated to:
1. Standard exposure (n =30)
2. ILT-enhanced exposure (n =30)
In the separate RCT*s, three ILT-enhancement strategies will be tested, one per
study:
Study 1: Maximizing expectancy violation
Study 2: Increasing fear and stimulus variability
Study 3: Increasing context variability
Assessments will take place prior to the exposure session (T1), during the
exposure session (T2), post intervention at one-week follow-up (T3), and at 3
month follow-up (T4).
Intervention
Irrespective of group allocation, participants will receive one 90-minute
exposure session. The control group will receive *standard exposure*, that is,
exposure as it is currently delivered in routine clinical practice. The
experimental group will receive ILT-enhanced exposure. ILT-enhancement
strategies will consist of 1) maximizing expectancy violation; 2) increasing
fear and stimulus variability; 3) increasing context variability.
Study burden and risks
Participants commit to being present at two research visits scheduled within
two weeks* time. During these visits, participants will be exposed to their
trauma-memory, their behavioral and physiological responses to trauma-related
stimuli will be assessed, and they will complete interviews and questionnaires
related to their PTSD symptoms. Exposure to trauma-related memories and stimuli
will be upsetting to participants. However, effective treatment for PTSD
includes confrontation with trauma memories and, although upsetting,
confrontation with trauma memories is harmless. Immediately upon completion of
the study, participants will enroll in trauma-focused treatment at the
treatment center for further processing of trauma memories.
Wassenaarseweg 52
Leiden 2333AK
NL
Wassenaarseweg 52
Leiden 2333AK
NL
Listed location countries
Age
Inclusion criteria
A. Satisfying DSM-5 defined criteria for Post-Traumatic Stress Disorder
B. One specific memory related to the index trauma
C. Age between 18 and 70 years
Exclusion criteria
A. Entry of patients with other psychiatric disorders will be permitted in
order to increase accrual of a clinically relevant sample; however, in cases
where PTSD is not judged to be the predominant disorder, participants will not
be eligible.
B. Current psychotherapeutic trauma-focused treatment (e.g. exposure; EMDR)
C. Patients with significant suicidal ideations or who have enacted suicidal
behaviors within 6 months prior to intake will be excluded from participation.
D. Mental retardation
E. Substance or alcohol dependence
F. Somatic illness that interfere with exposure interventions or planned
assessments (e.g. cardiac conditions)
G. Pregnancy
H. 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.
I. Participants that cannot commit to refraining from using sedative
medication/alcohol on the days of the intervention and testing.
J. Insufficient ability to speak and write Dutch
Design
Recruitment
metc-ldd@lumc.nl
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL73480.058.20 |