Respiratory Training vs Interoceptive Exposure for Anxiety

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Texas at Austin

Must not be taking: Psychotropic medications

Disqualifiers: Cardiovascular, Respiratory, Epilepsy, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares three treatments for people with severe anxiety: getting used to scary physical feelings, learning to breathe better, and learning about anxiety. These treatments aim to help those who don't respond well to usual methods or who relapse. The first treatment helps reduce fear of physical sensations, the second helps control breathing to reduce anxiety, and the third provides knowledge about anxiety.

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.

What data supports the effectiveness of the treatment Respiratory Training + Interoceptive Exposure for Anxiety Disorders?

Research shows that Capnometry Guided Respiratory Intervention (CGRI) is beneficial for panic disorder and PTSD, and Interoceptive Exposure (IE) is effective in reducing panic and anxiety. Combining these approaches may enhance treatment outcomes for anxiety disorders. ^{1 2 3 4 5}

Is the Respiratory Training + Interoceptive Exposure treatment safe for humans?

The treatment, including Capnometry Guided Respiratory Intervention (CGRI) and Interoceptive Exposure (IE), has been shown to be safe and well-tolerated in studies for conditions like panic disorder and PTSD. Participants generally adhered to the procedures, and the interventions were reported as acceptable and safe, with improvements in symptoms. ^{2 3 4 6 7}

How is the treatment 'Respiratory Training + Interoceptive Exposure for Anxiety Disorders' different from other treatments for anxiety disorders?

This treatment is unique because it combines Capnometry-Guided Respiratory Intervention (CGRI), which uses breathing techniques to manage anxiety, with Interoceptive Exposure (IE), which involves exposing patients to their own physical sensations to reduce fear. This dual approach targets both the physiological and psychological aspects of anxiety, making it distinct from standard treatments that may focus on only one aspect. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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 am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Capnometry-Guided Respiratory Intervention (Behavioral Intervention)
• Interoceptive Exposure (Behavioral Intervention)
• Psycho-Education (Behavioral Intervention)

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.

Participant Groups

Group I: Interoceptive Exposure (IE) Experimental Treatment 1 Intervention

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.

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

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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Dr. Elly Barry

University of Texas at Austin

Chief Medical Officer

MD from Harvard Medical School

Dr. Brian Windsor

University of Texas at Austin

Chief Executive Officer since 2023

PhD in Molecular Biology from the University of Texas at Austin

Freespira, Inc.

Collaborator

Trials

1

Recruited

180+

Findings from Research

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 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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Interoceptive hypersensitivity and interoceptive exposure in patients with panic disorder: specificity and effectiveness. [2023]

2. Switzerland 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

How does interoceptive exposure for panic disorder work? An uncontrolled case study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Repeated Interoceptive Exposure in Individuals With High and Low Anxiety Sensitivity. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Interoceptive exposure versus breathing retraining within cognitive-behavioural therapy for panic disorder with agoraphobia. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Origins and outlook of interoceptive exposure. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Investigation of a Capnometry Guided Respiratory Intervention in the Treatment of Posttraumatic Stress Disorder. [2022]