Social AnxietyBHBENCT07259005
Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety
A study testing Breathwork-Assisted Therapy 1 and Breathwork-Assisted Therapy 2 in people with Social Anxiety, run by Maastricht University at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Breathwork-Assisted Therapy 1 and Breathwork-Assisted Therapy 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Apr 2025to 10 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent in the English or Dutch language
- Aged between 18 and 65
- LSAS score ≥50
- Written informed consent
Who cannot join
- 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),
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht, Limburg, 6229ER
Mauro Cavarra, PhD, +31433882210, m.cavarra@maastrichtuniversity.nl
Mauro Cavarra, PhD
About this study
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.
Read more
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.
Read the 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
- Being tested
- Breathwork-Assisted Therapy 1, Breathwork-Assisted Therapy 2
- Keywords
- social anxiety, breathwork, psychotherapy, breathwork-assisted psychotherapy, altered states of consciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathwork-Assisted Therapy 1Behavioural
The investigational treatment will include two preparation sessions, two breathwork sessions, and two integration sessions.
Breathwork-Assisted Therapy 2Behavioural
The comparator treatment will include two preparation sessions, two breathwork sessions, and two integration sessions.
| Study group | Role | What they receive |
|---|---|---|
| Breathwork-assisted Therapy 1 | Experimental | The investigational treatment will include two preparation sessions, two breathwork sessions, and two integration sessions. Receives: 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. Receives: Behavioral: Breathwork-Assisted Therapy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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).
Measured: The GAT will be administered at baseline and 1 week after the last treatment session.
Heart Rate Variability
During the GAT heart-rate variability (HRV) will be assessed through the use of an ECG device.
Measured: HRV will be assessed at baseline and 1 week after the last treatment session.
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).
Measured: SC will be assessed at baseline and 1 week after the last treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start10 Apr 2025
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim PC Kuypers, PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259005
- Sponsor's protocol ID
- P154
- Other IDs
- NL87496.068.24
- Acronym
- BHBE
- Status last verified
- Apr 2025
- First submitted
- 10 Jun 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available upon reasonable and motivated request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety
- ClinicalTrials.gov ID
- NCT07259005
- Acronym / sponsor ID
- BHBE / P154
- Conditions
- Social Anxiety
- Keywords
- social anxiety, breathwork, psychotherapy, breathwork-assisted psychotherapy, altered states of consciousness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Apr 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Breathwork-assisted Therapy 1 | Experimental | Behavioral: Breathwork-Assisted Therapy 1The investigational treatment will include two preparation sessions, two breathwork sessions, and two integration sessions. |
| Breathwork-Assisted Therapy 2 | Active comparator | Behavioral: Breathwork-Assisted Therapy 2The control treatment will include two preparation sessions, two breathwork sessions, and two integration sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fluent in the English or Dutch language
- Aged between 18 and 65
- LSAS score ≥50
- Written informed consent
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathwork-Assisted Therapy 1The investigational treatment will include two preparation sessions, two breathwork sessions, and two integration sessions. | Behavioural | Breathwork-assisted Therapy 1 |
| Breathwork-Assisted Therapy 2The comparator treatment will include two preparation sessions, two breathwork sessions, and two integration sessions. | Behavioural | Breathwork-Assisted Therapy 2 |
Primary outcome
Liebowitz Social Anxiety Scale
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.
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
3 secondary outcomes
Getting Acquainted Task
Time frame: The GAT will be administered at baseline and 1 week after the last treatment session.
Heart Rate Variability
Time frame: HRV will be assessed at baseline and 1 week after the last treatment session.
Salivary Cortisol
Time frame: SC will be assessed at baseline and 1 week after the last treatment session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. Data will be made available upon reasonable and motivated request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kim PC Kuypers, PhD principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathwork-Assisted Therapy 1 and Breathwork-Assisted Therapy 2 in people with Social Anxiety, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauro Cavarra, PhD (+31433882210, fpn-pim_p154@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.