Our main objective is to investigate the feasibility and cognitive effects of applying self-regulation strategies learned from large-scale brain network balance neurofeedback training on active memory suppression in a PTSD patient population.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of the study is the behavioural effect of the application
of self-regulation strategies learned from neurofeedback training on
suppression-induced forgetting in the cognitive task. We expect that PTSD
patients can apply learned self-regulation strategies to improve memory
suppression.
Secondary outcome
Secondary outcome measures include an assessment of self-regulation performance
based on fMRI data, as well as effects of the application self-regulation
strategies on daily EMA survey outcomes.
Background summary
Post-traumatic stress disorder (PTSD) is a common and debilitating psychiatric
disorder that occurs after the experience of severely distressing trauma.
Current standard treatment - trauma-focused therapy - alone is insufficiently
effective for many patients and there is a critical need to investigate
innovative forward-facing interventions that may enhance long-term treatment
success by empowering patients to stay healthy. Recent findings in the domains
of cognitive psychology and neuroscience have started to shift the focus in
PTSD research away from the contents of the trauma memories itself, and rather
suggest that maladaptive control of those memories is a crucial underlying
core-deficit in PTSD. In particular, PTSD patients appear to have difficulties
with the suppression of thoughts and memories. Recent neuroimaging research has
proposed a network-based model of PTSD that attributes the underlying neural
mechanism to an imbalance in large-scale brain net-works. We have recently
developed a novel network-based rtfMRI neurofeedback paradigm for training
control over the relative balance between large-scale networks, which is
ideally suited for regaining the impaired executive control needed to
successfully suppress unwanted memories in PTSD by directly learning to
voluntarily self-regulate PTSD-related large-scale brain network balance. The
aim of the proposed study is to investigate the feasibility of applying
large-scale brain network balance neurofeedback training to a PTSD patient
population, and to assess the effects of learned self-regulation strategies on
memory suppression.
Study objective
Our main objective is to investigate the feasibility and cognitive effects of
applying self-regulation strategies learned from large-scale brain network
balance neurofeedback training on active memory suppression in a PTSD patient
population.
Study design
We will recruit individuals with a clinical PTSD diagnosis from collaborating
treatment centres in Nijmegen and Maastricht. Interested participants will
start with an intake procedure, including an intake interview, a short MRI
session and three questionnaires. After the intake day, participants will fill
in short daily surveys of ecologically momentary assessments (EMA; intrusion,
dissociation, mood and stress-related questions) for one week. Participants
will then take part in a three-day fMRI-based neurofeedback training procedure,
followed by the application of the self-regulation strategies learned from that
training in a cognitive task which assesses active memory suppression by
explicitly suppressing and recalling negative emotional pictures associated
with a neutral cue. After the cognitive task, participants will fill in short
daily EMA surveys for two more weeks. During the second week, participants will
be asked to additionally apply learned self-regulation strategies at least 3
times a day.
Study burden and risks
Negligible risk is associated with this study. Laying in an MRI scanner may be
uncomfortable for some participants. However, care is taken to get participants
accustomed to the scanning environment. Participants are additionally screened
for claustrophobia beforehand to minimize the potential of subjects
experiencing discomfort due to being in a small space. Watching negative
emotional pictures might also induce discomfort in some individuals. We will
hence brief participants on the content of the scenes they will view both
before they give consent to participate in the study and before the procedure
itself. Aware of the increased vulnerability of our study population, we will
take extensive additional measures in order to reduce the discomfort produced
by study procedures (outlined in chapter 13.2). Although there is no direct
benefit for participants, this study aims to provide new empirical insights
that will facilitate translation of scientific findings to clinical practice.
Findings of the proposed study have the potential to be directly translatable
to clinical settings, which may lead to improved and personalised treatment for
PTSD in the foreseeable future.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
Inclusion criteria
PTSD symptoms, according to DSM-5 criteria, as noted by participant's clinician
Exclusion criteria
• History of episode of psychotic or manic symptoms.
• Daily intake of benzodiazepines, or otherwise irregular intake of
benzodiazepines (*when needed*) but unable to withhold intake from the day
prior to each test session until the end of the each test session. An exception
is made for low doses of short-acting benzodiazepines that are prescribed for
insomnia (i.e. as sleep medication).
• A relevant neurological disorder (e.g., stroke, epilepsy, Multiple Sclerosis)
or severe physical disorder which is likely to impact assessment procedures or
results.
• Reports to be unable or unwilling to withhold recreational drug use and limit
alcohol use to maximally two units per day from the day prior to each test
session until the end of the each test session.
• Reports to be unable or unwilling to discuss frequency and timing of smoking
during and around study procedures, and adhere to an agreed smoking schedule
(personally adjusted to balance feasibility, participant needs and reliability
of study outcomes).
• General learning disability, or known to have intelligence Quotient (IQ) < 70
• Body weight >250 Kg.
• For women: pregnancy
• Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts,
metal in or around the body, deep brain stimulation, severe claustrophobia).
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 | NL78616.091.21 |