Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Computerized Hamilton Anxiety Scale
研究概览
简要总结
Purpose of the Research: The primary aim of the proposed study is to conduct a randomized parallel-group 2-arm clinical trial investigating capnometry-guided respiratory intervention (CGRI) for pathological anxiety. CGRI aims to raise end-tidal CO2 levels thereby lowering hyperventilation-induced respiratory alkalosis and its associated fear-eliciting somatic reactions. Psycho-education about anxiety and its effects (PsyEd) will serve as a credible control comparator.
详细描述
Low end-tidal CO2 (ETCO2), which is an accompanying feature of hyperventilation, has been associated with a variety of anxiety disorders, including panic disorder and social phobia. More recently, researchers have examined the efficacy of capnometry-guided respiratory intervention (CGRI) as a method for increasing ETCO2 and thereby reducing hyperventilation-induced anxiety/panic symptoms. Promising preliminary efficacy studies have shown that CGRI results in decreased panic symptom frequency and severity at a rate comparable to that of cognitive therapy. A recent uncontrolled proof-of-concept study showed that CGRI led to significant reductions in trauma symptoms in a sample of patients meeting DSM-5 criteria for PTSD. However, CGRI has not been adequately evaluated in the treatment of anxiety disorders other than panic disorder with or without agoraphobia.
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
Participants will be randomized by the undergraduate student coordinator for the project who is uninvolved with (1) running subjects through treatment; and (2) with data analysis. The study personnel involved in completing participants' treatment will not be blind. However, these personnel will not be involved in data maintenance or analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically elevated anxiety as indicated by an eight or higher on the Overall Anxiety Severity and Impairment Scale (OASIS).
- •Meets DSM-5 criteria for one or more of the following anxiety or trauma-related disorders as their "primary" mental disorder:
- •Generalized Anxiety Disorder
- •Panic Disorder
- •Health Anxiety
- •Agoraphobia
- •Social Anxiety Disorder
- •Posttraumatic Stress Disorder
- •Acute Stress Disorder
- •Adjustment Disorder with primary anxious mood
- •Anxiety disorder not otherwise specified
- •No current use of psychotropic medications or stable on current medications for at least 6 weeks
- •Able to arrange transportation to our laboratory for study appointments.
- •Fluent in English.
排除标准
- •No history of medical conditions that would contraindicate participation in fear-provocation or respiratory challenges, including:
- •Cardiovascular or respiratory disorders
- •High blood pressure
- •History of fainting
- •Pregnant or lactating
- •Not currently receiving other psychological treatment for anxiety.
- •No history of a suicide attempt within the past 6 months.
- •No history of psychosis within the past 6 months.
- •No history of moderate to severe alcohol or substance use disorder (with the exception of nicotine) within the past 3 months.
- •Does not endorse COVID-19 symptoms during the screening phase.
结局指标
主要结局
Computerized Hamilton Anxiety Scale
时间窗: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Change from baseline in anxiety symptom severity. Each item is assessed both in terms of frequency and severity. Scores on these probes are summed and divided by the number of response options. Higher scores index higher severity.
Overall Anxiety Severity and Impairment Scale
时间窗: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Change from baseline in self-reported transdiagnostic anxiety symptoms (range = 0 - 20, with higher scores indexing more symptoms).
次要结局
- Sheehan Disability Scale(Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13))
- Anxiety Sensitivity Composite Measure(Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13))
- PROMIS - Global Health (Mental Health Subdomain)(Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13))
- Modified DIAMOND(Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13))
研究者
Michael J. Telch
Professor of Psychology
University of Texas at Austin