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Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety

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ClinicalTrials.gov Identifier: NCT05427708
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
Freespira, Inc.
Information provided by (Responsible Party):
Michael J. Telch, University of Texas at Austin

Brief Summary:
Purpose of the Research: The primary aim of the proposed study is to conduct a randomized parallel-group 3-arm clinical trial comparing two mechanistically distinct interventions for pathological anxiety - (1) Interoceptive Exposure (IE) utilizing graduated exposure to somatic cues (respiratory, cardiac, vestibular) with the primary aim of reducing fear responding to the presence of interoceptive perturbations; (2) Capnometry-Guided Respiratory Intervention (CGRI) aimed at raising end-tidal CO2 levels thereby lowering hyperventilation-induced respiratory alkalosis and its associated fear-eliciting somatic reactions; and (3) Psycho-education about anxiety and its effects (PsyEd), which will serve as a credible control comparator.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Trauma Generalized Anxiety Disorder Panic Disorder Agoraphobia Illness Anxiety Disorder Social Anxiety Disorder Posttraumatic Stress Disorder Acute Stress Disorder Adjustment Disorder With Anxious Mood Behavioral: Interoceptive Exposure Device: Capnometry-Guided Respiratory Intervention Behavioral: Psycho-Education Not Applicable

Detailed Description:

Anxiety sensitivity - the tendency to perceive anxiety as threatening - is a widely recognized risk factor for the development of panic disorder and other anxiety-related psychopathology. Interoceptive exposure therapy consisting of repeated exposure to interoceptive cues using respiratory provocation challenges such as hyperventilation and inhalation of various concentrations of CO2-enriched air have shown promise in reducing AS and are often included in cognitive-behavioral treatments of panic disorder with or without agoraphobia.However, some patients are unwilling to undergo exposure-based treatments, while others who do show only partial response or subsequent relapse.

Alternatively, 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, neither IE or CGRI has been adequately evaluated in the treatment of anxiety disorders other than panic disorder with or without agoraphobia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will utilize a 3 x 3 randomized controlled trial design with intervention type as a between-subjects factor with three levels (IE, CGRI, PsyEd) and time points (baseline, posttreatment, 2-month follow-up) as a three-level within-subjects factor.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Interoceptive Exposure (IE)
Participants assigned to the interoceptive exposure condition will receive twice-weekly 90-minute in-person treatment sessions for four weeks. This treatment will include education about anxiety and factors that maintain anxiety symptoms. In addition, participants will be asked to perform exercises designed to activate potentially distressing - but harmless - bodily sensations that are commonly associated with stress and anxiety. Participants will also be encouraged to practice these exercises daily at home.
Behavioral: Interoceptive Exposure
See: Arm/group descriptions
Other Name: IE

Experimental: Capnometry-Guided Respiratory Intervention (CGRI)
If assigned to this condition, participants will be expected to complete twice-daily 17-minute tablet-assisted breathing exercises at home for four weeks. They will also receive brief phone check-ins with their study therapist weekly to review progress and troubleshoot any problems they may be experiencing. Last, these participants will have access to a paced-breathing app that provides audio recordings to maintain specified breathing rates for up to 10 minutes.
Device: Capnometry-Guided Respiratory Intervention
See: Arm/group descriptions
Other Name: CGRI

Active Comparator: Psycho-Education (PsyEd)
If assigned to this condition, participants will undergo one 90-minute video conferencing session with a therapist. During this session, they will be provided information about the nature and causes of anxiety-related disorders and learn tips for coping with anxiety symptoms when they arise. At the end of this session, participants will receive handouts that will help reinforce what they've learned.
Behavioral: Psycho-Education
See: Arm/group descriptions
Other Name: PsyEd




Primary Outcome Measures :
  1. Overall Anxiety Severity and Impairment Scale [ Time Frame: 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).

  2. Computerized Hamilton Anxiety Scale [ Time Frame: 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.


Secondary Outcome Measures :
  1. Sheehan Disability Scale [ Time Frame: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13) ]
    Change from baseline in overall disability (range = 0 - 30, with higher scores indexing more disability).

  2. 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) ]
    Change from baseline in quality of life (range = 4 - 20, with higher scores indexing higher quality of life).

  3. 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) ]
    This composite measure will incorporate scores on the Anxiety Sensitivity Index-3 (ASI-3), Body Sensations Questionnaire (BSQ), and Texas Multi-Factor Anxiety Sensitivity Scale (TMASS). Scores on each of these individual measures will be transformed into z scores and then averaged to derive this composite index. We will measure change from baseline in anxiety sensitivity.

  4. Modified DIAMOND [ Time Frame: Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13) ]
    Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinically elevated anxiety as indicated by an eight or higher on the Overall Anxiety Severity and Impairment Scale (OASIS).
  2. 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
  3. No current use of psychotropic medications or stable on current medications for at least 3 months
  4. Age 18+.
  5. Able to arrange transportation to our laboratory for study appointments.

Exclusion Criteria:

  1. 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
  2. Not currently receiving other psychological treatment for anxiety.
  3. No history of a suicide attempt within the past 6 months.
  4. No history of psychosis within the past 6 months.
  5. No history of alcohol or substance use disorder (with the exception of nicotine) within the past 3 months.
  6. Does not endorse COVID-19 symptoms during the screening phase.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05427708


Contacts
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Contact: Michael J Telch, PhD 512-814-5480 telch@austin.utexas.edu
Contact: Cate Fischer, MA 512-522-6216 utinterventionstudy@gmail.com

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Michael J Telch, PhD    512-814-5480    telch@austin.utexas.edu   
Contact: Cate Fischer, MA    512-522-6216    utinterventionstudy@gmail.com   
Principal Investigator: Michael J Telch, PhD         
Principal Investigator: Cate Fischer, MA         
Sponsors and Collaborators
University of Texas at Austin
Freespira, Inc.
Publications:
Maller RG, Reiss S. Anxiety sensitivity in 1984 and panic attacks in 1987. J Anxiety Disord. 1992;6(3):241-247.
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.
Craske MG, Barlow DH. Mastery of Your Anxiety and Panic: Therapist Guide. Published online 2006. doi:10.1093/med:psych/9780195311402.001.0001
Ley R. Blood, breath, and fears: A hyperventilation theory of panic attacks and agoraphobia. Clin Psychol Rev. 1985;5(4):271-285.

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Responsible Party: Michael J. Telch, Professor of Psychology, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT05427708    
Other Study ID Numbers: STUDY00002306
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Michael J. Telch, University of Texas at Austin:
Psychoeducation
Respiratory training
Interoceptive exposure
Transdiagnostic
Intervention
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Panic Disorder
Phobia, Social
Agoraphobia
Adjustment Disorders
Stress Disorders, Traumatic, Acute
Pathologic Processes
Mental Disorders
Trauma and Stressor Related Disorders
Phobic Disorders