Online Breathwork-Assisted Therapy for Social Anxiety

Social anxiety disorder (SAD) is diagnosed when social anxiety (SA) is so
intense that it causes clinically significant suffering and impairment in an
individual*s life (1). SAD is among the most prevalent mental health disorders,
with an estimated lifetime prevalence of 13% (2). Starting early in
adolescence, typically around the age of 13, and often persisting over time
(2), SA imposes significant personal and societal burdens (2). When combined
with other mental health conditions such as depression, it tends to predict a
more severe trajectory, including a heightened risk of suicide (2).
Individuals experiencing high levels of SA are caught in a harmful cycle shaped
by two primary factors: a profoundly negative self-image and acute awareness of
their increased physiological reactions (3, 4) in social situations (1). This
interaction leads to a vicious cycle they will a) anxiously anticipate the
feared situation (5), b) experience intense sympathetic responses (e.g.,
palpitations, sweating, blushing) (3, 4), c) which will confirm their
self-defeating beliefs (5), d) potentially impact their social performance, e)
and strengthen their anticipatory anxiety (5), thus completing the circle.
Therefore, high SA is understandably associated with isolation (6), reduced
socio-economic status, reduced quality of life, and comorbid conditions such as
depression, substance-use disorders, and cardiovascular disease (7).
The current first-line treatment for clinically significant SA is
cognitive-behavioral therapy, with studies estimating response rates between
50% and 65% (against 32% after placebo-treatment) (2). Considering that the
condition is undertreated due to these individuals* difficulties in meeting
therapists or other health professionals (8), the need for new, more accessible
treatments becomes even more apparent.
Psychedelic research has given a new impulse to explore the therapeutic
potential of experiencing altered states of consciousness (ASC) in therapeutic
settings (9) for conditions like substance addiction (10, 11), depression (12),
and anxiety linked with life-threatening illnesses (13-16). Of particular
relevance for this project, results from a proof-of-concept, double-blind,
placebo-controlled, randomized parallel-group trial showed a significantly
greater improvement in self-perception and speech performance after one dose of
ayahuasca in a sample of patients with SAD (17). Furthermore, MDMA-assisted
therapy showed promise in reducing social anxiety in adult autistic individuals
(18) and a protocol to investigate the effects of MDMA-assisted psychotherapy
in the treatment of SAD was recently published (19).
High-ventilation breathwork (HVB) is a non-pharmacological way to induce ASC
(20). It has been used therapeutically instead of psychedelics in countries
where these substances are outlawed (21). HVB-induced ASC causes a similar,
albeit less intense, phenomenology compared to psychedelics and can, in some
cases, generate full mystical experiences (20). While research on its
therapeutic potential is still in its infancy, reports suggest that HVB leads
to improvements in the same areas that psychedelics are researched for,
including anxiety and well-being (20). Particularly relevant for SA and
potentially for the treatment of SAD, considering that one of their core
features is a strong, negative self-evaluation (5), HVB has been found to
promote improvements in non-judgment of thoughts, dogmatic thinking, and
connection to others (20).

Primary Objective: The primary objective is to assess the effectiveness of
HVB-assisted therapy (HV-BAT) in reducing self-reported SA.

Secondary Objectives: The secondary objective is to assess the effectiveness of
HVB-assisted therapy (HV-BAT) in improving social performance in a social
interaction task (Getting Acquainted Task, GAT). Social performance will be
assessed by raters and heart rate variability (HRV) and salivary cortisol (SC)
will be used as a measure of physiological arousal in response to the task.

Additional Objectives: we will also test whether measures of therapeutic
alliance, treatment expectancy, personality, and ASC phenomenology influence
the potential outcomes. Finally, we will test whether the treatment will have
an effect on empathy, people perception, resilience and well-being.

Primary Hypothesis: we hypothesize that participants in the HV-BAT group will
show greater reductions in SA one week after the end of the study compared to
participants in the slow-paced breathwork-assisted therapy (SP-BAT) group.

Secondary Hypotheses: we hypothesize that participants in the HV-BAT group will
show better performance, increased HRV and decreased SC in response to the GAT
compared to the SP-BAT one week after the end of the study.

The study will be conducted according to a randomized, experimental,
between-groups design with two intervention options: high-ventilation
breathwork-assisted therapy and slow-paced breathwork-assisted therapy, with
the latter serving as an active control. The intervention will consist of a
total of 6 sessions including two preparation sessions, two breathwork
sessions, and two integration session.

Following t0 assessment, participants will be assigned a therapist who will
lead the preparation and integration sessions and a trained facilitator who
will lead the breathwork sessions. Following that, they will take part in a
first 90-minute preparation session aimed at establishing therapeutic alliance,
gathering personal and family history, SA history, and providing an explanation
of the treatment rationale. During this session the participant will also be
introduced to their breathwork facilitator. After the first preparation session
(post-p1), the LSAS, WAI-SR (for both the therapist and the breathwork
facilitator), STAI and CEQ will be administered.
About one to three days later, a 60-minute preparation session will take place
with the aim of discussing the participants* hypotheses concerning the cause of
their SA, setting intentions and treatment objectives for each breathwork
session, and establishing realistic and positive expectations. Before the
session participants will fill the GSGQ and the PANAS. After the session the
LSAS, PANAS and STAI will be administered.
One to three days later, a 60-minute breathwork session (bw1, either HVB or
SPB) will take place. Before the session, participants will be administered the
PANAS and GSQS. Once the session is complete, participants will fill out the
ASC phenomenology questionnaires (5D-ASC and PES), LSAS, STAI and PANAS.
One to three days after the breathwork session, participants will take part in
a 60-minute integration session aimed at processing the contents and potential
insights that emerged during the breathwork session, generalising them to daily
life and preparing for the next breathwork session. Before integration
sessions, participants will be administered the PANAS and GSQS. After
integration sessions they will be administered the LSAS, STAI and PANAS.
The second breathwork session will be held one to three days after the
integration session and will be followed by a final integration session after a
similar interval. All breathwork sessions will be held online in the lab and
the participant will connect with the facilitator through a computer. All
therapy sessions (i.e., preparation and integration) will take place online
from a location of the participant*s choosing. Online therapy has received
support from the scientific literature (65).

Participants will be invited to the lab twice for the administration of
behavioral tasks and two more times to participate to the breathwork sessions.
Each visit will last about 2 hours. The treatment will run online and includes
activities for a total 6.5h. Finally, we estimate a cumulative 1 hour to fill
in all questionnaires. The total maximum load per participant is therefore 11.5
hours. High-ventilation breathwork can produce an increased state of
physiological arousal accompanied by elevations in heart rate and blood
pressure that are considered safe in appropriately screened individuals. It
also produces altered states of consciousness that may, in some cases, be
characterized by transient anxiety. Participants may also experience discomfort
during the social interaction task. In case the treatment yields the expected
results, a potential benefit may be the reduction of social anxiety.