Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT07259005
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety
Sponsor:
Maastricht University
Organization:
Study Overview
Official Title:
Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BHBE
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NL87496.068.24 | REGISTRY | Dutch Trial Register | View |