Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMaastricht University

About this trial

This study aims to investigate the potential of supplementing psychotherapy with breathing techniques as a new online therapeutic approach to reduce social anxiety (SA). Clinically significant SA affects a substantial portion of the population (about 13%) and is associated with strong negative feelings of shame and anxiety in social settings. Such emotional distress leads to impairment in personal, relational, and professional functioning and may result in increasing degrees of social isolation.

In response to the demand for improved treatments for SA, this project aims to explore the efficacy of a novel treatment approach integrating online psychotherapy with online breathwork sessions designed to induce ASC.

We will recruit 96 individuals with SA, who will be randomly divided into two groups: one group will receive the new combined breathwork-assisted psychotherapy, and the other an active control intervention that does not induce ASC. Over the treatment duration, the effectiveness of these treatments will be closely monitored using established psychological scales and by observing patients in live interactions before and after therapy.

This project is expected to open the way to a more accessible and effective treatment option for a large group of people struggling with SA. More broadly, the findings will also contribute to our understanding of how ASC, induced through breathing techniques, can be used therapeutically. This could change the way a variety of mental health conditions (e.g., other anxiety-related conditions and depression) are treated, making a substantial impact on public health and the way mental health disorders are approached and managed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Fluent in the English or Dutch language

Aged between 18 and 65

LSAS score ≥50

Written informed consent

Disqualifiers

Hypotension (diastolic < 60 mmHg; systolic > 90 mmHg) or hypertension (diastolic > 90 mmHg; systolic > 140 mmHg)

History or presence of psychotic or bipolar disorders or first-degree relatives suffering from this

History of respiratory or cardiovascular/heart problems or disease, cerebral aneurysm

History of fainting or syncope, epilepsy or seizures

Trial design

Design model

Parallel

Treatments tested in this trial

  • Breathwork-Assisted Therapy 1

    Behavioral

    The investigational treatment will include two preparation sessions, two breathwork sessions, and two integration sessions.

  • Breathwork-Assisted Therapy 2

    Behavioral

    The comparator treatment will include two preparation sessions, two breathwork sessions, and two integration sessions.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Breathwork-assisted Therapy 1Experimental treatment 1 intervention
Group B: Breathwork-Assisted Therapy 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Liebowitz Social Anxiety Scale

The LSAS (25) is a widely recognized instrument designed to assess the severity of SA. The LSAS measures both the fear and avoidance associated with social and performance situations. It consists of 24 items, divided into two subscales: 13 items addressing social interaction situations and 11 items focusing on performance situations. Each item is rated on a Likert scale from 0 (none) to 3 (severe) for fear, and from 0 (never) to 3 (usually) for avoidance, yielding a total possible score range of 0 to 144. The scale's dual focus allows for a comprehensive assessment of SA, making it a valuable tool for both therapy settings and research. The LSAS has demonstrated strong psychometric properties, including high internal consistency and test-retest reliability (26). It is also sensitive to changes in symptomatology, which makes it useful for evaluating treatment outcomes (27). The scale's validity has been established through correlations with other

Time frame
The LSAS will be administered at all study timepoints: baseline, after each treatment session, 1 week and 1 month after the end of treatment.

Secondary outcomes

1

Getting Acquainted Task

The GAT is an assessment tool used to evaluate SA by observing how an individual performs in a structured social interaction (29). The participant will be paired with a confederate and asked to engage in a conversation to get to know each other. This scenario is designed to elicit behaviors and responses indicative of SA, such as difficulty initiating conversation, discomfort, or avoidance behaviors. The task will involve different confederates at the two assessment timepoints to reduce habituation effects and will be video recorded and analyzed later for social performance assessment (29, 30). The assessment will be carried out by blinded raters on two dimensions: anxious appearance (fidgeting, blushing, laughing nervously and feelings of nervousness) and social behavior (making eye contact, completing of sentences, coherence, silences, listening, showing interest, responding) (29).

Time frame
The GAT will be administered at baseline and 1 week after the last treatment session.
2

Heart Rate Variability

During the GAT heart-rate variability (HRV) will be assessed through the use of an ECG device.

Time frame
HRV will be assessed at baseline and 1 week after the last treatment session.
3

Salivary Cortisol

Before, immediately after and 30 minutes after the end of the GAT, saliva samples will be collected to measure the concentration of salivary cortisol (SC).

Time frame
SC will be assessed at baseline and 1 week after the last treatment session.

Other outcomes

1

State and Trait Anxiety

State and Trait Anxiety Inventory (STAI) The State-Trait Anxiety Inventory (STAI; 66) is a widely used psychological instrument designed to measure two distinct types of anxiety: state anxiety (temporary, situational anxiety) and trait anxiety (a general tendency to experience anxiety across situations). The STAI consists of 40 self-report items, divided equally into two subscales: the State Anxiety Scale (S-Anxiety) and the Trait Anxiety Scale (T-Anxiety). Each item is rated on a 4-point Likert scale, with scores ranging from 20 to 80 for each subscale, where higher scores indicate greater levels of anxiety.

Time frame
The STAI will be administered at all study timepoints: baseline, after each treatment session, 1 week and 1 month after the end of treatment.
2

Empathy

The Interpersonal Reactivity Index (IRI) (51) is a 28-item questionnaire consisting of 4 discrete seven-item scales i.e. 'Fantasy' (tendency to imaginatively transpose oneself into fictional situations), 'Perspective-Taking' (tendency to spontaneously adopt the psychological viewpoint of others), 'Empathic Concern' (taps the respondents' feelings of warmth, compassion, and concern for others), and 'Personal Distress' (assesses self-oriented feelings of anxiety and discomfort resulting from tense interpersonal settings).

Time frame
The IRI at baseline and 1 week after the last treatment session.
3

Well-Being

The World Health Organisation - Well-Being Index (WHO-5) (52) is a short, self-reported measure designed to evaluate subjective well-being. The WHO-5 is widely used in therapy and research settings to assess general emotional well-being and screen for depression. The index consists of five items, each reflecting a positive aspect of mental health, such as feeling cheerful, calm, active, rested, and interested in daily life. Respondents rate each item on a 6-point Likert scale ranging from 0 (at no time) to 5 (all of the time), based on their experiences over the past two weeks. The total score of the WHO-5 ranges from 0 to 25, with higher scores indicating better well-being. A score below 13 suggests poor well-being. The WHO-5 is valued for its simplicity, brevity, and strong psychometric properties, including high internal consistency and sensitivity to change (52).

Time frame
The WHO-5 at baseline, 1 week after the last treatment session and one month after the last treatment session.
4

Resilience

The Resilience Scale (RS) is a well-validated instrument designed to measure the resilience levels of individuals, reflecting their ability to cope with stress and adversity (53). The RS aims to quantify the personal qualities that enable individuals to thrive despite challenging circumstances. The scale consists of 25 items and respondents rate each item on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree).

Time frame
The RS will be administered at baseline, 1 week after the last treatment session and one month after the last treatment session.

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