Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

Официальное название

Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Capnometry-Guided Respiratory Intervention
  See: Arm/group descriptions
• Поведенческое Psycho-Education
  See: Arm/group descriptions

Первичные конечные точки

• Overall Anxiety Severity and Impairment Scale [Срок оценки: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)]
• Computerized Hamilton Anxiety Scale [Срок оценки: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)]

Вторичные конечные точки (4)

• Sheehan Disability Scale [Срок оценки: 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) [Срок оценки: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)]
• Anxiety Sensitivity Composite Measure [Срок оценки: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)]
• Modified DIAMOND [Срок оценки: Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13)]

Критерии участия

Критерии включения

• 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
• Age 18+.
• Able to arrange transportation to our laboratory for study appointments.
• Fluent in English.

Критерии исключения

• No history of medical conditions that would contraindicate participation in fear-provocation or respiratory challenges, including:

• Cardiovascular or respiratory disorders
• High blood pressure
• Epilepsy
• Strokes
• Seizures
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Texas at Austin — Austin

Публикации

• Reiss S, Peterson RA, Gursky DM, McNally RJ. Anxiety sensitivity, anxiety frequency and the prediction of fearfulness. Behav Res Ther. 1986;24(1):1-8. doi: 10.1016/0005-7967(86)90143-9. No abstract available. PMID 3947307
• Li W, Zinbarg RE. Anxiety sensitivity and panic attacks: a 1-year longitudinal study. Behav Modif. 2007 Mar;31(2):145-61. doi: 10.1177/0145445506296969. PMID 17307932
• Maller RG, Reiss S. Anxiety sensitivity in 1984 and panic attacks in 1987. J Anxiety Disord. 1992;6(3):241-247.
• Schmidt NB, Lerew DR, Jackson RJ. Prospective evaluation of anxiety sensitivity in the pathogenesis of panic: replication and extension. J Abnorm Psychol. 1999 Aug;108(3):532-7. doi: 10.1037//0021-843x.108.3.532. PMID 10466277
• Telch MJ, Rosenfield D, Lee HJ, Pai A. Emotional reactivity to a single inhalation of 35% carbon dioxide and its association with later symptoms of posttraumatic stress disorder and anxiety in soldiers deployed to Iraq. Arch Gen Psychiatry. 2012 Nov;69(11):1161-8. doi: 10.1001/archgenpsychiatry.2012.8. PMID 23117637
• Cobb AR, Lancaster CL, Meyer EC, Lee HJ, Telch MJ. Pre-deployment trait anxiety, anxiety sensitivity and experiential avoidance predict war-zone stress-evoked psychopathology. Journal of Contextual Behavioral Science. 2017;6(3):276-287.
• Schmidt NB, Telch MJ. Role of fear of fear and safety information in moderating the effects of voluntary hyperventilation. Behav Ther. 1994;25(2):197-208.
• Beck JG, Shipherd JC, Zebb BJ. How does interoceptive exposure for panic disorder work? An uncontrolled case study. J Anxiety Disord. 1997 Sep-Oct;11(5):541-56. doi: 10.1016/s0887-6185(97)00030-3. PMID 9407272

Идентификаторы

NCT: NCT05427708 · STUDY00002306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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