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

Primary Purpose

Anxiety Disorders, Trauma, Generalized Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interoceptive Exposure
Capnometry-Guided Respiratory Intervention
Psycho-Education
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Psychoeducation, Respiratory training, Interoceptive exposure, Transdiagnostic, Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Interoceptive Exposure (IE)

Capnometry-Guided Respiratory Intervention (CGRI)

Psycho-Education (PsyEd)

Arm Description

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.

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.

If assigned to the psycho-education condition, participants will undergo once-weekly 20-minute video conferencing session with a therapist for four weeks. During these sessions, 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 their sessions with the therapist, they will receive handouts that will help reinforce what they've learned.

Outcomes

Primary Outcome Measures

Overall Anxiety Severity and Impairment Scale
Change from baseline in self-reported transdiagnostic anxiety symptoms (range = 0 - 20, with higher scores indexing more symptoms).
Computerized Hamilton Anxiety Scale
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

Sheehan Disability Scale
Change from baseline in overall disability (range = 0 - 30, with higher scores indexing more disability).
PROMIS - Global Health (Mental Health Subdomain)
Change from baseline in quality of life (range = 4 - 20, with higher scores indexing higher quality of life).
Anxiety Sensitivity Composite Measure
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.
Modified DIAMOND
Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores.

Full Information

First Posted
March 1, 2022
Last Updated
August 1, 2023
Sponsor
University of Texas at Austin
Collaborators
Freespira, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05427708
Brief Title
Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety
Official Title
Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Freespira, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Psychoeducation, Respiratory training, Interoceptive exposure, Transdiagnostic, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interoceptive Exposure (IE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Capnometry-Guided Respiratory Intervention (CGRI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Psycho-Education (PsyEd)
Arm Type
Active Comparator
Arm Description
If assigned to the psycho-education condition, participants will undergo once-weekly 20-minute video conferencing session with a therapist for four weeks. During these sessions, 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 their sessions with the therapist, they will receive handouts that will help reinforce what they've learned.
Intervention Type
Behavioral
Intervention Name(s)
Interoceptive Exposure
Other Intervention Name(s)
IE
Intervention Description
See: Arm/group descriptions
Intervention Type
Device
Intervention Name(s)
Capnometry-Guided Respiratory Intervention
Other Intervention Name(s)
CGRI
Intervention Description
See: Arm/group descriptions
Intervention Type
Behavioral
Intervention Name(s)
Psycho-Education
Other Intervention Name(s)
PsyEd
Intervention Description
See: Arm/group descriptions
Primary Outcome Measure Information:
Title
Overall Anxiety Severity and Impairment Scale
Description
Change from baseline in self-reported transdiagnostic anxiety symptoms (range = 0 - 20, with higher scores indexing more symptoms).
Time Frame
Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Title
Computerized Hamilton Anxiety Scale
Description
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.
Time Frame
Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale
Description
Change from baseline in overall disability (range = 0 - 30, with higher scores indexing more disability).
Time Frame
Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Title
PROMIS - Global Health (Mental Health Subdomain)
Description
Change from baseline in quality of life (range = 4 - 20, with higher scores indexing higher quality of life).
Time Frame
Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Title
Anxiety Sensitivity Composite Measure
Description
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.
Time Frame
Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Title
Modified DIAMOND
Description
Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores.
Time Frame
Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J Telch, PhD
Phone
512-814-5480
Email
telch@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cate Fischer, MA
Phone
512-522-6216
Email
utinterventionstudy@gmail.com
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Telch, PhD
Phone
512-814-5480
Email
telch@austin.utexas.edu
First Name & Middle Initial & Last Name & Degree
Cate Fischer, MA
Phone
512-522-6216
Email
utinterventionstudy@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael J Telch, PhD
First Name & Middle Initial & Last Name & Degree
Cate Fischer, MA

12. IPD Sharing Statement

Plan to Share IPD
No
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Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety

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