Clinical Trials in the Netherlands / NCT07259005
Recruiting Not applicable

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

NCT07259005 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2025-04-10
Last updated
2025-12-02

Condition(s) studied

Social Anxiety

Investigational drug(s) / intervention(s)

Breathwork-Assisted Therapy 1Breathwork-Assisted Therapy 2

Breathwork-Assisted Therapy 1: The investigational treatment will include two preparation sessions, two breathwork sessions, and two integration sessions.

Breathwork-Assisted Therapy 2: The comparator treatment will include two preparation sessions, two breathwork sessions, and two integration sessions.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Fluent in the English or Dutch language * Aged between 18 and 65 * LSAS score ≥50 * Written informed consent Exclusion Criteria: * 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 * History of panic disorder or panic attacks, * Having had adverse reactions with prior breathwork sessions (i.e., fainting), * Pregnancy, thinking one might be pregnant, trying to get pregnant, or breastfeeding * Any problems affecting the ability to pace breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea), any other physical/mental health conditions or current life events impairing the ability to engage in activities involving breath control * Taking any regular medication other than the contraceptive pill, including medications to reduce blood pressure (i.e., Ramipril or other ACE-inhibitors) and beta-blockers (i.e., Propranolol).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Maastricht University Maastricht Limburg Recruiting

More Maastricht University trials in the Netherlands

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07259005 on ClinicalTrials.gov ↗ ← All trials in the Netherlands