Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
University of Texas at Austin
RECRUITING
Austin
Contact Information
Primary
Michael J Telch, PhD
telch@austin.utexas.edu
512-814-5480
Backup
Shristi Saraff
utinterventionstudy@gmail.com
Time Frame
Start Date: 2022-08-22
Estimated Completion Date: 2027-05
Participants
Target number of participants: 180
Treatments
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.
Authors
Cate Fischer
Sponsors
Collaborators: Freespira, Inc.
Leads: University of Texas at Austin

This content was sourced from clinicaltrials.gov