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Recruiting NCT05427708

Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

No phase Interventional Anxiety Disorders Trauma Generalized Anxiety Disorder Panic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capnometry-Guided Respiratory Intervention, Psycho-Education.
Who it may be relevant to
Registry conditions: Anxiety Disorders, Trauma, Generalized Anxiety Disorder, Panic Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device Capnometry-Guided Respiratory Intervention
    See: Arm/group descriptions
  • Behavioral Psycho-Education
    See: Arm/group descriptions

Primary outcome measures

  • Overall Anxiety Severity and Impairment Scale [Time frame: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)]
  • Computerized Hamilton Anxiety Scale [Time frame: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)]
Secondary outcome measures (4)
  • Sheehan Disability Scale [Time frame: 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) [Time frame: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)]
  • Anxiety Sensitivity Composite Measure [Time frame: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)]
  • Modified DIAMOND [Time frame: Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Texas at Austin — Austin

Publications

  • 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

Identifiers

NCT: NCT05427708 · STUDY00002306

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗