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Respiratory Training vs Interoceptive Exposure for Anxiety

Verified Trial
N/A
Recruiting
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
No current use of psychotropic medications or stable on current medications for at least 3 months
Must not have
No history of a suicide attempt within the past 6 months.
Not currently receiving other psychological treatment for anxiety.
Timeline
Screening 3 days
Treatment 4 weeks
Follow Up 2 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will compare two different treatments for anxiety - interoceptive exposure and capnometry-guided respiratory intervention - to a control group receiving psychoeducation.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from facing fear-inducing sensations in IE, changes in breathing patterns with CGRI, and general distress related to discussing anxiety during PsyEd.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with an anxiety or trauma-related disorder like PTSD or panic disorder.
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I haven't used psychotropic drugs recently or have been stable on them for 3+ months.
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I am 18 years old or older.
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I can get to the lab for my study appointments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have not attempted suicide in the past 6 months.
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I am not currently undergoing any treatment for anxiety.

Timeline

Screening ~ 3 days
Treatment ~ 4 weeks
Follow Up ~2 months
This trial's timeline: 3 days for screening, 4 weeks for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Computerized Hamilton Anxiety Scale
Overall Anxiety Severity and Impairment Scale
Secondary outcome measures
Anxiety Sensitivity Composite Measure
Modified DIAMOND
PROMIS - Global Health (Mental Health Subdomain)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Interoceptive Exposure (IE)Experimental Treatment1 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 Treatment1 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 Control1 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.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
346 Previous Clinical Trials
79,962 Total Patients Enrolled
Freespira, Inc.UNKNOWN

Media Library

Capnometry-Guided Respiratory Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05427708 — N/A
Adjustment Disorder Research Study Groups: Interoceptive Exposure (IE), Capnometry-Guided Respiratory Intervention (CGRI), Psycho-Education (PsyEd)
Adjustment Disorder Clinical Trial 2023: Capnometry-Guided Respiratory Intervention Highlights & Side Effects. Trial Name: NCT05427708 — N/A
Capnometry-Guided Respiratory Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05427708 — N/A
Adjustment Disorder Patient Testimony for trial: Trial Name: NCT05427708 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What primary goal is this clinical experiment trying to accomplish?

"This trial seeks to assess Overall Anxiety Severity and Impairment Scale over the course of Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow Up (Week 13). Additionally, secondary outcomes such as Sheehan Disability Scale, Anxiety Sensitivity Composite Measure, and Modified DIAMOND will be evaluated. The former measures overall disability ranging from 0 - 30 with higher scores indicating more impairment whereas the latter captures changes in anxiety sensitivity by combining scores on ASI-3, BSQ, and TMASS into a single index."

Answered by AI

How many participants are engaged in the current clinical trial?

"Affirmative. Clinicaltrials.gov data indicates the trial's commencement date of August 1st 2022, and its present search for 102 patients from one medical centre."

Answered by AI

Are there any opportunities for people to register with this trial at present?

"Affirmative. Clinicaltrials.gov shows that the trial is currently enrolling patients, with 102 expected to participate across one site since it was first posted on August 1st 2022 and last updated on the same day."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Nebraska
Other
Texas
How old are they?
65+
What site did they apply to?
University of Texas at Austin
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+

What questions have other patients asked about this trial?

is this remote ? How long do screening visits take? How often would I have to go to Austin?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I’d like to get treatments. I’d like to get help on this. I saw your ad in my Facebook page.
PatientReceived no prior treatments
To be part of a study and compensation. Haven’t left home in 3 years please help.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. University of Texas at Austin: < 24 hours
Average response time
  • < 2 Days
~79 spots leftby May 2025