Breathe Hard to Breathe Easy: Online Breathwork-Assisted Therapy for Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Liebowitz Social Anxiety Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent in the English or Dutch language
- •Aged between 18 and 65
- •LSAS score ≥50
- •Written informed consent
排除标准
- •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).
结局指标
主要结局
Liebowitz Social Anxiety Scale
时间窗: 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
次要结局
- 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.)