Anxiety Disorders, Trauma, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Illness Anxiety Disorder, Social Anxiety Disorder, Posttraumatic Stress Disorder, Acute Stress Disorder, Adjustment Disorder With Anxious Mood
Conditions
Keywords
Psychoeducation, Respiratory training, Transdiagnostic, Intervention
Brief 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.
Detailed description
Low end-tidal CO2 (ETCO2), which is an accompanying feature of hyperventilation, has been associated with a variety of anxiety disorders, including panic disorder and social phobia. More recently, researchers have examined the efficacy of capnometry-guided respiratory intervention (CGRI) as a method for increasing ETCO2 and thereby reducing hyperventilation-induced anxiety/panic symptoms. Promising preliminary efficacy studies have shown that CGRI results in decreased panic symptom frequency and severity at a rate comparable to that of cognitive therapy. A recent uncontrolled proof-of-concept study showed that CGRI led to significant reductions in trauma symptoms in a sample of patients meeting DSM-5 criteria for PTSD. However, CGRI has not been adequately evaluated in the treatment of anxiety disorders other than panic disorder with or without agoraphobia.
Interventions
DEVICECapnometry-Guided Respiratory Intervention
See: Arm/group descriptions
BEHAVIORALPsycho-Education
See: Arm/group descriptions
Sponsors
Freespira, Inc.
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants will be randomized by the undergraduate student coordinator for the project who is uninvolved with (1) running subjects through treatment; and (2) with data analysis. The study personnel involved in completing participants' treatment will not be blind. However, these personnel will not be involved in data maintenance or analysis.
Intervention model description
This study will utilize a 2 x 3 randomized controlled trial design with intervention type as a between-subjects factor with two levels (CGRI, PsyEd) and time points (baseline, posttreatment, 2-month follow-up) as a three-level within-subjects factor.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Clinically elevated anxiety as indicated by an eight or higher on the Overall Anxiety Severity and Impairment Scale (OASIS). 2. 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 3. No current use of psychotropic medications or stable on current medications for at least 6 weeks 4. Age 18+. 5. Able to arrange transportation to our laboratory for study appointments. 6. Fluent in English.
Exclusion criteria
1. No history of medical conditions that would contraindicate participation in fear-provocation or respiratory challenges, including: * Cardiovascular or respiratory disorders * High blood pressure * Epilepsy * Strokes * Seizures * History of fainting * Pregnant or lactating 2. Not currently receiving other psychological treatment for anxiety. 3. No history of a suicide attempt within the past 6 months. 4. No history of psychosis within the past 6 months. 5. No history of moderate to severe alcohol or substance use disorder (with the exception of nicotine) within the past 3 months. 6. Does not endorse COVID-19 symptoms during the screening phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Anxiety Severity and Impairment Scale | Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13) | Change from baseline in self-reported transdiagnostic anxiety symptoms (range = 0 - 20, with higher scores indexing more symptoms). |
| Computerized Hamilton Anxiety Scale | Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sheehan Disability Scale | Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13) | Change from baseline in overall disability (range = 0 - 30, with higher scores indexing more disability). |
| PROMIS - Global Health (Mental Health Subdomain) | Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13) | Change from baseline in quality of life (range = 4 - 20, with higher scores indexing higher quality of life). |
| Anxiety Sensitivity Composite Measure | Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13) | 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. |
| Modified DIAMOND | Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13) | Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores. |
Countries
United States
Contacts
Primary ContactMichael J Telch, PhD
Backup ContactShristi Saraff
Outcome results
None listed