To investigate whether augmentation of one standardized exposure session for SAD with tVNS results in lower fear compared to expsoure plus sham. We also aim to test if tVNS yields enhanced retention of extinction memory, during a second exposure…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective Units of Distress (SUDs): participants will provide fear ratings
(ranging from 0; no fear to 100 most anxiety imaginable) prior, during and
after both exposure sessions. Main outcome is the change of the SUDs during the
first exposure session.
Secondary outcome
Secondary outcome measures:
- SUDs ratings during the second exposure session, i.e. retention of extinction
memory
- Self-reported social anxiety (Social Phobia Scale)
- Cardiac activity (Heart Rate Variability; HRV)
- Harm Expectancies
Background summary
Social Anxiety Disorder (SAD) is a common and debilitating anxiety disorder,
with fear of public speaking as one of the core symptoms. Exposure Therapy is a
proven effective treatment strategy for SAD. Notwithstanding its efficacy, many
patients remain symptomatic after treatment and remission rates tend to be low.
Extinction learning is thought to be the most important mechanism of action of
ET. Preclinical studies recently demonstrated that vagus nerve stimulation
promotes extinction learning, compared to sham. As such, vagus nerve
stimulation seems a promising enhancement strategy for exposure therapy. Here,
we aim to examine for the first time if transcutaneous stimulation of the
auricular branch of the vagus nerve (tVNS) enhances exposure in patients
suffering from SAD, compared to sham.
Study objective
To investigate whether augmentation of one standardized exposure session for
SAD with tVNS results in lower fear compared to expsoure plus sham. We also aim
to test if tVNS yields enhanced retention of extinction memory, during a second
exposure session compared to sham. Secondary, we aim to test if tVNS explore
the effects on tVNS on levels of self-reported social anxiety and cardiac
activity, and explore if individual characteristics are related to changes in
the primary outcome.
Study design
A single-blind placebo controlled intervention study
Intervention
All participants receive two standardized sessions of exposure for SAD, 26
randomly allocated participants will receive tVNS during the first session, 26
will receive sham stimulation during the first session.
Study burden and risks
Participants will visit the Leiden Universiteit Behandel en Expertise Centrum
for four visits: a baseline assessment, for two exposure sessions, and a post
intervention assessment The follow-up assessment will be conducted online.
Participation will take approximately 5 hours in total. Concerning the tVNS and
sham stimulation: The stimulation frequency, intensity and duration are within
safety limits established from prior work in humans (Kreuzer et al., 2012).
Participants will be screened for cardiac or neurological disorders, metal
pieces in the body, pregnancy, migraine and medication or drug use. The
presence of any of these conditions will preclude participation in the proposed
study. Previous studies have used comparable or higher tVNS stimulation
frequency, intensity and duration without reporting adverse side-effects (e.g.
Kraus et al., 2007; Dietrich et al., 2008). The stimulation is not painful,
only a typical short-lasting skin sensation (i.e., itching and/or tingling) can
be experienced.
Wassenaarseweg 52
Leiden 2333AK
NL
Wassenaarseweg 52
Leiden 2333AK
NL
Listed location countries
Age
Inclusion criteria
A. Between 18-70 years old
B. Social Anxiety Disorder (SAD) as established with a structured interview
(MINI), and with speech anxiety as primary fear
C. Self reported SAD symptoms above clinical cut-off (score > 30 on the LSAS).
Exclusion criteria
A. Prior non response to exposure therapy (i.c. speech exposure) for SAD
symptoms, as defined by the patient*s report of receiving specific and regular
exposure assignments as part of previous therapy.
B. Prior participation in tVNS research
C. Entry of patients with other mood or anxiety disorders will be permitted in
order to increase accrual of a clinically relevant sample; however in cases
where SAD is not judged to be the predominant disorder, participants will not
be eligible.
D. Psychosis or delusion disorders (current or in the past)
E. Patients with significant suicidal ideations or who have enacted suicidal
behaviors within 6 months prior to intake will be excluded from participation
and referred for appropriate clinical intervention.
F. Mental retardation
G. (History of) Substance or alcohol dependence
H. Somatic illness
I. Pregnancy or lactation
J. Antipsychotic medication
K. Participants that use antidepressants or benzodiazepines will not be
excluded, but have to be on a stable dose for at least 6 weeks prior to
enrollment.
L. Insufficient ability to speak and write Dutch
Design
Recruitment
Medical products/devices used
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 | NL66143.058.18 |
| OMON | NL-OMON20935 |