The current study*s primary aim is to test how trauma-focused therapy affects PTSD symptom-specific neural activity, and investigate neural markers that may predict treatment response to trauma-focused exposure. Furthermore, it is expected that…
ID
Source
Brief title
Condition
- Other condition
- Dissociative disorders
Synonym
Health condition
Post-traumatic stress disorder
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are differences in BOLD activation patterns between
responders vs. non-responders following the fMRI paradigms. A treatment
responder analysis will be conducted to identify (1) pre-post changes in brain
activation responding to a script-driven trauma confrontation protocol and
emotion reactivity task and (2) pre-therapy activation which could predict
treatment outcome. Functional imaging data will be analyzed with
region-of-interest and whole-brain exploratory analysis.
Secondary outcome
Secondary parameters include 1) the psychophysiological reactivity elicited
during the functional imaging paradigms (script driven imagery and emotion
reactivity), 2) resting-state functional imaging data for connectivity
analyses, and 3) patient characteristics to describe the patients and
characterize possible subgroups of patients (those who will and those who will
not benefit from treatment).
Background summary
Post-traumatic stress disorder (PTSD) is a debilitating condition in which
patients suffer from intrusions, avoidance, and hyperarousal following a
traumatic event. Trauma-focused psychotherapies (TFT), including exposure and
re-processing of the traumatic memories, are most effective in reducing PTSD
symptomatology. Approximately one third of PTSD patients do not depict
noteworthy improvements following treatment, and no reliable predictors for
treatment outcome have been identified yet. A promising path towards finding
objective treatment predictors is to understand brain-based characteristics and
the neural underpinnings of PTSD symptomatology. Neurobiological models suggest
that PTSD symptoms correspond with dysfunctional fronto-limbic neural circuitry
and that psychotherapy strengthens top-down modulation of hyperactive limbic
regions. Meanwhile, it has been hypothesized that PTSD patients with elevated
dissociation levels do not respond equally well to treatment as dissociation is
expected to interfere with habituation during exposure and negatively affects
lower brain regions regulating physical reactions. Only few neuroimaging
pre-post treatment studies in PTSD have provided empirical evidence for the
proposed models. There is a strong necessity for well-powered neuroimaging
research to identify treatment-related changes in brain function and neural
predictors of who will and will not profit from trauma-focused therapy.
Study objective
The current study*s primary aim is to test how trauma-focused therapy affects
PTSD symptom-specific neural activity, and investigate neural markers that may
predict treatment response to trauma-focused exposure. Furthermore, it is
expected that assessment of psychophysiological reactivity and functional
connectivity between regions of interest can elucidate other potential markers
of psychotherapeutic gains in PTSD.
Study design
The current study employs an observational pre-post therapy design in which
symptom-related brain activation of 60 PTSD patients enrolled in trauma-focused
therapy will be assessed before and after the trauma-processing phase. During
functional neuroimaging, participants will undergo two experimental tasks. The
first task is script-driven imagery, in which participants attentively listen
to an audiotaped narrative of a personal a) traumatic and b) neutral event in a
blocked design. The second task is an emotion reactivity task to assess neural
correlates of conscious and non-conscious processing of fearful (vs. neutral)
faces.
Study burden and risks
Participation consists of 4 sessions (total duration: 7 hours); Participants
undergo a neuroimaging session (duration: 90 min) and a clinical assessment
session (duration: 60-120 minutes) once before and after therapy. The first
clinical assessment session comprises a clinical interview (45-60 minutes),
script collection (30 minutes), and filling out a questionnaire booklet (60
minutes). In the neuroimaging sessions, participants answer several
questionnaires (30 minutes), and then undergo fMRI scanning (45 minutes)
including two tasks (script-driven imagery and emotional reactivity). During
scanning, the participants* psychophysiological data (heart rate, skin
conductance reactivity, and respiration) will be recorded. The second clinical
assessment session entails an interview to assess PTSD severity post-treatment
(45-60 minutes). While acknowledging the participation burden and potential
distress related to the study procedures, all techniques have been extensively
tested in traumatized patient groups and trauma-focused research participation
has presented minimal risk to its subjects. Concerning the fMRI scanner,
participants will be exposed to a field strength of 3 Tesla and scanner noise.
Thus far, there is no evidence to suggest that exposing humans to a magnetic
field of this strength has a negative influence on health. With regard to the
noise, earplugs will be provided. To minimize the risk of claustrophobic
sensations in the scanner, patients will be screened for a history of
claustrophobia and will be offered to lay in a mock scanner to estimate their
comfort level inside a MR scanner. No disadvantages of the heart rate measures
and skin conductance measures are known or expected. The study is not intended
to benefit the participants directly, but they will receive a compensation of ¤
70,- for their participation.
Grote Kruistraat 2
Groningen 9712TS
NL
Grote Kruistraat 2
Groningen 9712TS
NL
Listed location countries
Age
Inclusion criteria
1. Participants must be full of age (18 years or older).
2. Meet the criteria for post-traumatic stress disorder (PTSD).
3. Must be enrolled in trauma-focused psychotherapy (TFT).
4. Participants must be capable of giving consent.
Exclusion criteria
1. Presence of metallic devices, e.g. metal implants or cardiac pacemaker
2. Meet diagnostic criteria for
a. Pain disorder
b. Bipolar disorder
c. Dissociative Identity Disorder
d. Schizophrenia
e. Neurological disorders
3. Alcohol or drug abuse in the last 6 months
4. Suspected pregnancy
5. Claustrophobia
6. Refusal that general practitioner will be informed when structural brain
abnormalities could be detected during experiment
Design
Recruitment
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 | NL70837.042.19 |