Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety
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|ClinicalTrials.gov Identifier: NCT05427708|
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : August 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|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||Behavioral: Interoceptive Exposure Device: Capnometry-Guided Respiratory Intervention Behavioral: Psycho-Education||Not Applicable|
Anxiety sensitivity - the tendency to perceive anxiety as threatening - is a widely recognized risk factor for the development of panic disorder and other anxiety-related psychopathology. Interoceptive exposure therapy consisting of repeated exposure to interoceptive cues using respiratory provocation challenges such as hyperventilation and inhalation of various concentrations of CO2-enriched air have shown promise in reducing AS and are often included in cognitive-behavioral treatments of panic disorder with or without agoraphobia.However, some patients are unwilling to undergo exposure-based treatments, while others who do show only partial response or subsequent relapse.
Alternatively, 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, neither IE or CGRI has been adequately evaluated in the treatment of anxiety disorders other than panic disorder with or without agoraphobia.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study will utilize a 3 x 3 randomized controlled trial design with intervention type as a between-subjects factor with three levels (IE, CGRI, PsyEd) and time points (baseline, posttreatment, 2-month follow-up) as a three-level within-subjects factor.|
|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.|
|Official Title:||Respiratory Training vs Interoceptive Exposure in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial|
|Estimated Study Start Date :||August 1, 2022|
|Estimated Primary Completion Date :||May 2025|
|Estimated Study Completion Date :||May 2025|
Experimental: Interoceptive Exposure (IE)
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.
Behavioral: Interoceptive Exposure
See: Arm/group descriptions
Other Name: IE
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.
Device: Capnometry-Guided Respiratory Intervention
See: Arm/group descriptions
Other Name: CGRI
Active Comparator: Psycho-Education (PsyEd)
If assigned to this condition, participants will undergo one 90-minute video conferencing session with a therapist. During this session, 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 this session, participants will receive handouts that will help reinforce what they've learned.
See: Arm/group descriptions
Other Name: PsyEd
- Overall Anxiety Severity and Impairment Scale [ Time Frame: 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 [ Time Frame: 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.
- Sheehan Disability Scale [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13) ]Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05427708
|Contact: Michael J Telch, PhDemail@example.com|
|Contact: Cate Fischer, MAfirstname.lastname@example.org|
|United States, Texas|
|University of Texas at Austin||Recruiting|
|Austin, Texas, United States, 78712|
|Contact: Michael J Telch, PhD 512-814-5480 email@example.com|
|Contact: Cate Fischer, MA 512-522-6216 firstname.lastname@example.org|
|Principal Investigator: Michael J Telch, PhD|
|Principal Investigator: Cate Fischer, MA|