Health TrialsbyHealthPanel

Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety

ConditionsAnxiety DisordersTraumaGeneralized Anxiety DisorderPanic DisorderAgoraphobiaIllness Anxiety DisorderSocial Anxiety DisorderPosttraumatic Stress DisorderAcute Stress DisorderAdjustment Disorder With Anxious Mood
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas at Austin

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically elevated anxiety as indicated by an eight or higher on the Overall Anxiety Severity and Impairment Scale (OASIS).

Generalized Anxiety Disorder

Panic Disorder

Health Anxiety

Disqualifiers

Cardiovascular or respiratory disorders

High blood pressure

Epilepsy

Strokes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capnometry-Guided Respiratory Intervention

    Device

    See: Arm/group descriptions

  • Psycho-Education

    Behavioral

    See: Arm/group descriptions

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Capnometry-Guided Respiratory Intervention (CGRI)Experimental treatment 1 intervention
Group B: Psycho-Education (PsyEd)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Anxiety Severity and Impairment Scale

Change from baseline in self-reported transdiagnostic anxiety symptoms (range = 0 - 20, with higher scores indexing more symptoms).

Time frame
Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
2

Computerized Hamilton Anxiety Scale

Change from baseline in anxiety symptom severity. Each item is assessed both in terms of frequency and severity. Scores on these probes are summed and divided by the number of response options. Higher scores index higher severity.

Time frame
Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)

Secondary outcomes

1

Sheehan Disability Scale

Change from baseline in overall disability (range = 0 - 30, with higher scores indexing more disability).

Time frame
Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
2

PROMIS - Global Health (Mental Health Subdomain)

Change from baseline in quality of life (range = 4 - 20, with higher scores indexing higher quality of life).

Time frame
Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
3

Anxiety Sensitivity Composite Measure

This composite measure will incorporate scores on the Anxiety Sensitivity Index-3 (ASI-3), Body Sensations Questionnaire (BSQ), and Texas Multi-Factor Anxiety Sensitivity Scale (TMASS). Scores on each of these individual measures will be transformed into z scores and then averaged to derive this composite index. We will measure change from baseline in anxiety sensitivity.

Time frame
Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
4

Modified DIAMOND

Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores.

Time frame
Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

Freespira, Inc.

Collaborator

Source ClinicalTrials.gov
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