Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

NCT05427708 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00002306
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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; Illness Anxiety Disorder; Social Anxiety Disorder; Posttraumatic Stress Disorder; Acute Stress Disorder; Adjustment Disorder With Anxious Mood

Keywords

Psychoeducation; Respiratory training; Transdiagnostic; Intervention

Outcome Measures

Primary Outcomes (2)

• Overall Anxiety Severity and Impairment Scale

  Change from baseline in self-reported transdiagnostic anxiety symptoms (range = 0 - 20, with higher scores indexing more symptoms).

  Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)

• 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.

  Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)

Secondary Outcomes (4)

• Sheehan Disability Scale

  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)

  Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)

• Anxiety Sensitivity Composite Measure

  Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)

• Modified DIAMOND

  Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13)

Study Arms (2)

Capnometry-Guided Respiratory Intervention (CGRI)

EXPERIMENTAL

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

Psycho-Education (PsyEd)

ACTIVE COMPARATOR

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.

Behavioral: Psycho-Education

Interventions

Capnometry-Guided Respiratory Intervention DEVICE

See: Arm/group descriptions

Also known as: CGRI

Capnometry-Guided Respiratory Intervention (CGRI)

Psycho-Education BEHAVIORAL

See: Arm/group descriptions

Also known as: PsyEd

Psycho-Education (PsyEd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Freespira, Inc.: collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• Maller RG, Reiss S. Anxiety sensitivity in 1984 and panic attacks in 1987. J Anxiety Disord. 1992;6(3):241-247.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• Craske MG, Barlow DH. Mastery of Your Anxiety and Panic: Therapist Guide. Published online 2006. doi:10.1093/med:psych/9780195311402.001.0001

  BACKGROUND

• Margraf J, Barlow DH, Clark DM, Telch MJ. Psychological treatment of panic: work in progress on outcome, active ingredients, and follow-up. Behav Res Ther. 1993 Jan;31(1):1-8. doi: 10.1016/0005-7967(93)90036-t.

  PMID: 8093337 BACKGROUND

• Telch MJ, Lucas JA, Schmidt NB, Hanna HH, LaNae Jaimez T, Lucas RA. Group cognitive-behavioral treatment of panic disorder. Behav Res Ther. 1993 Mar;31(3):279-87. doi: 10.1016/0005-7967(93)90026-q.

  PMID: 8476402 BACKGROUND

• Ley R. Blood, breath, and fears: A hyperventilation theory of panic attacks and agoraphobia. Clin Psychol Rev. 1985;5(4):271-285.

  BACKGROUND

• Studer RK, Danuser B, Hildebrandt H, Arial M, Wild P, Gomez P. Hyperventilation in anticipatory music performance anxiety. Psychosom Med. 2012 Sep;74(7):773-82. doi: 10.1097/PSY.0b013e31825e3578. Epub 2012 Jul 23.

  PMID: 22826290 BACKGROUND

• Kaplan A, Mannarino AP, Nickell PV. Evaluating the Impact of Freespira on Panic Disorder Patients' Health Outcomes and Healthcare Costs within the Allegheny Health Network. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):175-181. doi: 10.1007/s10484-020-09465-0.

  PMID: 32342249 BACKGROUND

• Meuret AE, Wilhelm FH, Ritz T, Roth WT. Feedback of end-tidal pCO2 as a therapeutic approach for panic disorder. J Psychiatr Res. 2008 Jun;42(7):560-8. doi: 10.1016/j.jpsychires.2007.06.005. Epub 2007 Aug 3.

  PMID: 17681544 BACKGROUND

• Tolin DF, McGrath PB, Hale LR, Weiner DN, Gueorguieva R. A Multisite Benchmarking Trial of Capnometry Guided Respiratory Intervention for Panic Disorder in Naturalistic Treatment Settings. Appl Psychophysiol Biofeedback. 2017 Mar;42(1):51-58. doi: 10.1007/s10484-017-9354-4.

  PMID: 28194546 BACKGROUND

• Meuret AE, Rosenfield D, Seidel A, Bhaskara L, Hofmann SG. Respiratory and cognitive mediators of treatment change in panic disorder: evidence for intervention specificity. J Consult Clin Psychol. 2010 Oct;78(5):691-704. doi: 10.1037/a0019552.

  PMID: 20873904 BACKGROUND

• Ostacher MJ, Fischer E, Bowen ER, Lyu J, Robbins DJ, Suppes T. Investigation of a Capnometry Guided Respiratory Intervention in the Treatment of Posttraumatic Stress Disorder. Appl Psychophysiol Biofeedback. 2021 Dec;46(4):367-376. doi: 10.1007/s10484-021-09521-3.

  PMID: 34468913 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Wounds and Injuries; Generalized Anxiety Disorder; Panic Disorder; Agoraphobia; Phobia, Social; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Michael J Telch, PhD

CONTACT

512-814-5480; telch@austin.utexas.edu

Shristi Saraff

CONTACT

utinterventionstudy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: This study will utilize a 2 x 3 randomized controlled trial design with intervention type as a between-subjects factor with two levels (CGRI, PsyEd) and time points (baseline, posttreatment, 2-month follow-up) as a three-level within-subjects factor.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: June 22, 2022
• Study Start: August 22, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)