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

NCT07259005 | Recruiting

• 2 other identifiers: P154NL87496.068.24
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety

Keywords

social anxiety; breathwork; psychotherapy; breathwork-assisted psychotherapy; altered states of consciousness

Outcome Measures

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

  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 (3)

• Getting Acquainted Task

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

• Heart Rate Variability

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

• Salivary Cortisol

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

Other Outcomes (7)

• State and Trait Anxiety

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

• Empathy

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

• Well-Being

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

Study Arms (2)

Breathwork-assisted Therapy 1

EXPERIMENTAL

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

Behavioral: Breathwork-Assisted Therapy 1

Breathwork-Assisted Therapy 2

ACTIVE COMPARATOR

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

Behavioral: Breathwork-Assisted Therapy 2

Interventions

Breathwork-Assisted Therapy 1 BEHAVIORAL

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

Breathwork-assisted Therapy 1

Breathwork-Assisted Therapy 2 BEHAVIORAL

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

Breathwork-Assisted Therapy 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in the English or Dutch language
• Aged between 18 and 65
• LSAS score ≥50
• Written informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

RECRUITING

Study Officials

• Kim PC Kuypers, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauro Cavarra, PhD

CONTACT

‭+31433882210‬; fpn-pim_p154@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A list containing one code for each prospective participant will be created. Through a randomization algorithm, a person not involved in the study will assign each code to one of the two interventions. Participants who fulfill the inclusion and do not meet the exclusion criteria will be assigned the first available code from the list. Participants will be blind to the study hypotheses and the specific technique used in the other treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted according to a randomized experimental between-groups design with two intervention options: HV-BAT (N=48) and SP-BAT (N=48), with the latter serving as an active control. The intervention will consist of a fully online breathwork-assisted therapy (BAT) program (HV-BAT or SP-BAT), each lasting about 3 weeks. The treatment will include two preparation session, two breathwork sessions, and two integration sessions. baseline (t0), before each preparation session, after each preparation session (post-p1 and post-p2), before each breathwork session, after each breathwork session (post-bw1 and post-bw2), before each integration session, after each integration session (post-int1 and post-int2), 1 week after the last integration session (t1) and 1 month after last integration session (t2).

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: December 2, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 10, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)