Recruiting

Respiratory Training vs Interoceptive Exposure

Sponsor:

University of Texas at Austin

Code:

NCT05427708

Conditions

Anxiety Disorders

Trauma

Generalized Anxiety Disorder

Panic Disorder

Agoraphobia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Capnometry-Guided Respiratory Intervention

Psycho-Education

Study Details

Brief summary:

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.

Conditions

Anxiety Disorders

Trauma

Generalized Anxiety Disorder

Panic Disorder

Agoraphobia

Study ID

NCT05427708

Start date

Aug 22, 2022

Status verified date

Aug, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • Anxiety disorder not otherwise specified
3. No current use of psychotropic medications or stable on current medications for at least 6 weeks
4. Age 18+.
5. Able to arrange transportation to our laboratory for study appointments.
6. Fluent in English.

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 moderate to severe 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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Psycho-Education (PsyEd)

If assigned to the psycho-education condition, participants will watch pre-recorded 20-minute video presentations once-weekly for four weeks. They will meet with a study staff member to watch these videos, who will be available to answer any questions. 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.

Interventions

Capnometry-Guided Respiratory Intervention

See: Arm/group descriptions

Psycho-Education

See: Arm/group descriptions

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Locations

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Contacts

Principal Investigator:

Michael J Telch, PhD

More Information

Sponsor

University of Texas at Austin

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Keywords

  • Psychoeducation
  • Respiratory training
  • Transdiagnostic
  • Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2025-08-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.