Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT05427708
Status
Recruiting
Apply to this trial

Conditions

  • Acute Stress Disorder
  • Adjustment Disorder With Anxious Mood
  • Agoraphobia
  • Anxiety Disorders
  • Generalized Anxiety Disorder
  • Illness Anxiety Disorder
  • Panic Disorder
  • Posttraumatic Stress Disorder
  • Social Anxiety Disorder
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Capnometry-Guided Respiratory Intervention — DEVICE
    See: Arm/group descriptions
  • Psycho-Education — BEHAVIORAL
    See: Arm/group descriptions

Study Details

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.

Key Dates

Start date
Aug 22, 2022
Status verified
Aug 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall Anxiety Severity and Impairment Scale [ Time Frame: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at AustinAustinTexas78712
Michael J Telch, PhD
[email protected]
512-814-5480
Shristi Saraff
[email protected]
Michael J Telch, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Austin, TX

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Texas at Austin· Austin, TX

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