Respiratory Training vs Interoceptive Exposure for Anxiety

Overseen By Shristi Saraff

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Psychotropic medications

Disqualifiers: Cardiovascular, Respiratory, Epilepsy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new breathing technique, Capnometry-Guided Respiratory Intervention (CGRI), to help reduce anxiety. CGRI involves special breathing exercises designed to alleviate fear and panic symptoms. Another group will learn about anxiety through video sessions, providing tools to manage anxiety symptoms. Individuals with high anxiety levels, such as those with Generalized Anxiety Disorder or Panic Disorder, might be suitable candidates, particularly if they are not currently taking psychotropic medications or are stable on them. As an unphased trial, this study offers a unique opportunity to explore innovative anxiety management techniques.

Will I have to stop taking my current medications?

If you are currently taking psychotropic medications, you must have been stable on them for at least 6 weeks to participate in the trial. If you are not stable or are starting new medications, you may need to stop or adjust them before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Capnometry-Guided Respiratory Intervention (CGRI) is generally safe and well-tolerated. In past studies, CGRI improved symptoms in people with panic disorder and PTSD (post-traumatic stress disorder). The FDA has approved this treatment for these conditions, indicating its safety for them.

CGRI uses a device to guide breathing exercises, helping manage symptoms by adjusting carbon dioxide (CO2) levels in the body. Studies have found the treatment easy to use and acceptable, with no serious side effects reported.

Overall, evidence suggests that CGRI is a safe option for managing anxiety-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new ways to manage anxiety disorders. The Capnometry-Guided Respiratory Intervention (CGRI) is unique because it uses a tablet-assisted breathing exercise to help participants regulate their breathing patterns, which can be done conveniently at home. This breathing technique is guided by capnometry, a method that monitors carbon dioxide levels to optimize breathing, potentially reducing anxiety symptoms. On the other hand, the Interoceptive Exposure approach provides psycho-education through videos, helping participants understand anxiety and offering coping strategies. These methods stand out by focusing on direct physiological and educational interventions rather than medication, providing alternative options for those who prefer non-drug treatments.

What evidence suggests that this trial's treatments could be effective for anxiety disorders?

In this trial, participants may receive Capnometry-Guided Respiratory Intervention (CGRI), which previous studies have shown to effectively reduce panic symptoms. Research suggests that CGRI helps by controlling breathing and increasing carbon dioxide levels, preventing anxiety-related symptoms. Studies using a system called Freespira® demonstrated consistent benefits for people with panic disorders. Another study found that CGRI reduced symptoms in veterans with PTSD. These findings suggest that CGRI could be a promising treatment for people with anxiety disorders. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with anxiety or trauma-related disorders like PTSD, social anxiety, and agoraphobia. Participants should not be on new psychotropic meds or have a recent history of substance abuse, psychosis, or suicide attempts. They must be able to travel to the study site.

Inclusion Criteria

I have been diagnosed with Acute Stress Disorder.

I have been diagnosed with an anxiety or trauma-related disorder like PTSD or panic disorder.

I can get to the lab for my study appointments.

Exclusion Criteria

I am not currently undergoing any treatment for anxiety.

You are currently pregnant or breastfeeding.

You have not experienced any episodes of psychosis in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one of three interventions: Interoceptive Exposure, Capnometry-Guided Respiratory Intervention, or Psycho-Education for four weeks

4 weeks

Weekly sessions (in-person or virtual) depending on the intervention

Post-treatment Assessment

Participants are assessed for changes in anxiety symptoms and other measures

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2-month follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Capnometry-Guided Respiratory Intervention
• Interoceptive Exposure
• Psycho-Education

Trial Overview The study compares two treatments for pathological anxiety: Interoceptive Exposure (IE), which involves facing physical sensations that cause fear; Capnometry-Guided Respiratory Intervention (CGRI), which corrects breathing patterns; and Psycho-Education about anxiety as a control group.

How Is the Trial Designed?

Group I: Capnometry-Guided Respiratory Intervention (CGRI) Experimental Treatment 1 Intervention

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.

Group II: Psycho-Education (PsyEd) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Freespira, Inc.

Collaborator

Trials

1

Recruited

180+

Published Research Related to This Trial

Interoceptive exposure (IE) is an effective behavioral intervention for reducing anxiety sensitivity, particularly well-established in treating panic disorder, and shows promise for other anxiety-related conditions like PTSD and social anxiety disorder.

Despite its potential as a transdiagnostic treatment for various disorders, including depression and eating disorders, IE remains underutilized in clinical practice, highlighting a need for greater awareness and research on its broader applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Origins and outlook of interoceptive exposure. Boettcher, H., Brake, CA., Barlow, DH.[2022]

In a study of 55 participants with PTSD, the Capnometry Guided Respiratory Intervention (CGRI) was well tolerated and resulted in 88% of participants achieving a significant reduction in PTSD symptoms, as measured by the Clinician Administered PTSD Scale (CAPS-5), at the 2-month follow-up.

The CGRI treatment led to a mean decrease in CAPS-5 scores from 49.5 to 27.1, indicating substantial improvement in PTSD symptoms, while also positively affecting respiratory rates and carbon dioxide levels, suggesting a potential mechanism for its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of a Capnometry Guided Respiratory Intervention in the Treatment of Posttraumatic Stress Disorder. Ostacher, MJ., Fischer, E., Bowen, ER., et al.[2022]

In a real-world study of 1,569 patients with panic disorder and PTSD, Capnometry Guided Respiratory Intervention (CGRI) led to significant symptom reductions, with panic disorder patients experiencing a 50.2% decrease in severity scores and PTSD patients a 41.1% decrease.

The treatment showed high adherence rates of around 75% and low dropout rates of about 10%, indicating that CGRI is a feasible and effective home-based therapeutic option for managing symptoms of panic disorder and PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world outcomes of an innovative digital therapeutic for treatment of panic disorder and PTSD: A 1,500 patient effectiveness study. Cuyler, RN., Katdare, R., Thomas, S., et al.[2022]

Interoceptive exposure (IE) using 35% CO2 was found to be effective in reducing panic symptoms, panic-related fears, and general anxiety in 17 patients with Panic Disorder after six sessions.

The study identified two patterns of fear response during IE: 'Habituators,' who showed quicker and more positive outcomes, and those who did not experience fear reduction, suggesting that IE may work through different mechanisms for different individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does interoceptive exposure for panic disorder work? An uncontrolled case study. Beck, JG., Shipherd, JC., Zebb, BJ.[2019]

In a study of 38 individuals with panic disorder and agoraphobia, treatment including interoceptive exposure was found to be more effective than breathing retraining in reducing panic frequency and overall severity immediately after treatment and at a six-month follow-up.

Both treatment approaches were generally effective, but the interoceptive exposure group showed better improvements in managing phobic fears and general anxiety, highlighting the importance of exposure to feared bodily sensations in cognitive-behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interoceptive exposure versus breathing retraining within cognitive-behavioural therapy for panic disorder with agoraphobia. Craske, MG., Rowe, M., Lewin, M., et al.[2019]

The study identified four key types of interoceptive fears related to panic disorder: pseudoneurological, gastrointestinal, cardiorespiratory, and dissociative feelings, using the Body Sensations Questionnaire (BSQ) with a focus on interoceptive exposure exercises.

Specific interoceptive exposure tasks, such as hyperventilation and holding breath, were effective in significantly reducing pseudoneurological fears, indicating their potential utility in cognitive behavioral therapy for panic disorder, while highlighting the need for new tasks targeting cardiorespiratory and dissociative symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interoceptive hypersensitivity and interoceptive exposure in patients with panic disorder: specificity and effectiveness. Lee, K., Noda, Y., Nakano, Y., et al.[2023]

In a study involving 48 participants with varying anxiety sensitivity, repeated interoceptive exposure through hyperventilation led to a decrease in defensive responses, particularly in those with high anxiety sensitivity.

After two sessions, high anxiety sensitive individuals showed reduced anxiety symptoms and no longer exhibited heightened startle responses during hyperventilation, indicating that repeated exposure may help diminish panic-related responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeated Interoceptive Exposure in Individuals With High and Low Anxiety Sensitivity. Holtz, K., Hamm, AO., Pané-Farré, CA.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34468913/

Investigation of a Capnometry Guided Respiratory ... CGRI is a digital therapeutic effective in panic disorder that measures and displays end-tidal carbon dioxide (EtCO 2 ) and respiratory rate (RR) in real-time.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8553693/

Investigation of a Capnometry Guided Respiratory ... Subsequent studies have found one CGRI system (Freespira®) to be effective in reducing panic symptoms (Kaplan et al., 2020; Tolin et al., 2017).

3. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2022.976001/full

Real-world outcomes of an innovative digital therapeutic ... Objective: Prior clinical trials have shown consistent clinical benefit for Capnometry Guided Respiratory Intervention (CGRI), ...

4. mdpi.com mdpi.com/2227-9032/13/4/390

Capnometry-Guided Respiratory Intervention in Veteran ... The aim of this study was to examine patterns of symptom reduction in veterans with PTSD treated with a Capnometry-Guided Respiratory Intervention (CGRI).

5. mentalhealthjournal.org mentalhealthjournal.org/articles/real-world-evaluation-of-a-novel-technology-enabled-capnometry-assisted-breathing-therapy-for-panic-disorder.html

Real-world Evaluation of a Novel Technology-enabled ... The clinical improvements observed in this pilot suggest that capnometry-assisted breathing therapy is a valuable tool for patients suffering from panic- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11855826/

Capnometry-Guided Respiratory Intervention in Veteran ... The aim of this study was to examine patterns of symptom reduction in veterans with PTSD treated with a Capnometry-Guided Respiratory Intervention (CGRI).

7. mentalhealthjournal.org mentalhealthjournal.org/articles/real-world-evaluation-of-a-novel-technology-enabled-capnometry-assisted-breathing-therapy-for-panic-disorder.pdf

assisted Breathing Therapy for Panic Disorder The capnometry-assisted breathing treatment is delivered via a hand-held respiratory sensor, nasal sampling cannula, and software that guides.

8. health.ny.gov health.ny.gov/health_care/medicaid/ebbrac/meetings/2024/docs/2024-11-07_freespira_rpt.pdf

Freespira for Panic Disorder and Posttraumatic Stress ... A multisite benchmarking trial of capnometry guided respiratory intervention for panic disorder in naturalistic treatment settings. Appl ...

9. intechopen.com intechopen.com/chapters/1199281

Capnometry-Guided Breathing and PTSD: A Novel ... The FDA cleared the treatment for panic disorder/panic attacks in 2013 and post-traumatic stress disorder in 2018 in adults ages 18 and over. This chapter will ...