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

NCT ID: NCT07259005

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2028-04-10

Brief 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.

Detailed Description

Rationale: Clinically significant social anxiety affects a substantial portion of the population (about 13%) and is associated with strong negative feelings of shame, anxiety in social settings, and significant personal, relational and professional impairment. Importantly, recent estimates suggest that between half and one-third of these individuals do not respond to conventional therapies. Recent findings show better treatment outcomes for a variety of mental health conditions when psychological treatments are complemented by sessions during which participants experience altered states of consciousness. In response to the demand for improved treatments for social anxiety, this project aims to investigate the efficacy of a novel treatment approach integrating online therapy with online breathwork sessions designed to induce altered states of consciousness.

Objective: The aim is to test online-delivered breathwork-assisted therapy to reduce social anxiety.

Study design: The study will be conducted according to a randomized, experimental, between-groups design with two breathwork-assisted therapy interventions. The intervention will consist of a total of 6 sessions including two preparation sessions, two breathwork sessions, and two integration session.

Study population: 96 adult individuals with social anxiety (Liebowitz Social Anxiety Scale score > 49).

Intervention (if applicable): Breathwork-assisted therapy 1 or breathwork-assisted therapy 2.

Main study parameters/endpoints: Primary outcomes will be self-reported levels of social anxiety. Performance and physiological response in a social interaction task will be used as a secondary measure.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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. 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.

Conditions

Social Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Breathwork-assisted Therapy 1

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

Group Type: EXPERIMENTAL

Breathwork-Assisted Therapy 1

Intervention Type: BEHAVIORAL

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

Breathwork-Assisted Therapy 2

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

Group Type: ACTIVE_COMPARATOR

Breathwork-Assisted Therapy 2

Intervention Type: BEHAVIORAL

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

Interventions

Breathwork-Assisted Therapy 1

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

Intervention Type: BEHAVIORAL

Breathwork-Assisted Therapy 2

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim PC Kuypers, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Mauro Cavarra, PhD

Role: CONTACT

fpn-pim_p154@maastrichtuniversity.nl

‭+31433882210‬

Facility Contacts

Mauro Cavarra, PhD

Role: primary

m.cavarra@maastrichtuniversity.nl

‭+31433882210‬

Other Identifiers

NL87496.068.24

Identifier Type: REGISTRY

Identifier Source: secondary_id

P154

Identifier Type: -

Identifier Source: org_study_id