Anxiety DisordersNCT05427708
Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety
A study testing Capnometry-Guided Respiratory Intervention and Psycho-Education in people with Anxiety Disorders and Trauma, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Trauma, Generalized Anxiety Disorder
- What is being tested?
- Capnometry-Guided Respiratory Intervention and Psycho-Education
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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
Show all 13Show fewer
- History of fainting
- Pregnant or lactating
- Not currently receiving other psychological treatment for anxiety.
- No history of a suicide attempt within the past 6 months.
- No history of psychosis within the past 6 months.
- No history of moderate to severe alcohol or substance use disorder (with the exception of nicotine) within the past 3 months.
- Does not endorse COVID-19 symptoms during the screening phase.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shristi Saraff contact
United States1 site, 1 recruiting
- Recruiting
University of Texas at Austin
Austin, Texas, 78712
Michael J Telch, PhD, 512-814-5480, telch@austin.utexas.edu
Shristi Saraff, utinterventionstudy@gmail.com
About this study
Official title: Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical 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.
Read the 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.
- Conditions
- Anxiety Disorders, Trauma, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Illness Anxiety Disorder
- Being tested
- Capnometry-Guided Respiratory Intervention, Psycho-Education
- Keywords
- Psychoeducation, Respiratory training, Transdiagnostic, Intervention
- Medical subject headings
- Anxiety Disorders, Wounds and Injuries, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Phobia, Social, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnometry-Guided Respiratory InterventionDevice
Also called CGRI
See: Arm/group descriptions
Psycho-EducationBehavioural
Also called PsyEd
See: Arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Capnometry-Guided Respiratory Intervention (CGRI) | Experimental | 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. Receives: Device: Capnometry-Guided Respiratory Intervention |
| Psycho-Education (PsyEd) | Active comparator | 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. Receives: Behavioral: Psycho-Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Anxiety Severity and Impairment Scale
Change from baseline in self-reported transdiagnostic anxiety symptoms (range = 0 - 20, with higher scores indexing more symptoms).
Measured: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
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.
Measured: Pre-Treatment (Week 0), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Secondary outcomes (4)
Sheehan Disability Scale
Change from baseline in overall disability (range = 0 - 30, with higher scores indexing more disability).
Measured: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
PROMIS - Global Health (Mental Health Subdomain)
Change from baseline in quality of life (range = 4 - 20, with higher scores indexing higher quality of life).
Measured: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
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.
Measured: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
Modified DIAMOND
Change from baseline in DIAMOND Diagnostic Interview + Health Anxiety Questionnaire scores.
Measured: Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start22 Aug 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Freespira, Inc.
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427708
- Sponsor's protocol ID
- STUDY00002306
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reiss S, Peterson RA, Gursky DM, McNally RJ. Anxiety sensitivity, anxiety frequency and the prediction of fearfulness. Behav Res Ther. 1986;24(1):1-8. doi: 10.1016/0005-7967(86)90143-9. No abstract available.
PubMed 3947307Li W, Zinbarg RE. Anxiety sensitivity and panic attacks: a 1-year longitudinal study. Behav Modif. 2007 Mar;31(2):145-61. doi: 10.1177/0145445506296969.
PubMed 17307932Maller RG, Reiss S. Anxiety sensitivity in 1984 and panic attacks in 1987. J Anxiety Disord. 1992;6(3):241-247.
Schmidt NB, Lerew DR, Jackson RJ. Prospective evaluation of anxiety sensitivity in the pathogenesis of panic: replication and extension. J Abnorm Psychol. 1999 Aug;108(3):532-7. doi: 10.1037//0021-843x.108.3.532.
PubMed 10466277Telch MJ, Rosenfield D, Lee HJ, Pai A. Emotional reactivity to a single inhalation of 35% carbon dioxide and its association with later symptoms of posttraumatic stress disorder and anxiety in soldiers deployed to Iraq. Arch Gen Psychiatry. 2012 Nov;69(11):1161-8. doi: 10.1001/archgenpsychiatry.2012.8.
PubMed 23117637Cobb AR, Lancaster CL, Meyer EC, Lee HJ, Telch MJ. Pre-deployment trait anxiety, anxiety sensitivity and experiential avoidance predict war-zone stress-evoked psychopathology. Journal of Contextual Behavioral Science. 2017;6(3):276-287.
Schmidt NB, Telch MJ. Role of fear of fear and safety information in moderating the effects of voluntary hyperventilation. Behav Ther. 1994;25(2):197-208.
Beck JG, Shipherd JC, Zebb BJ. How does interoceptive exposure for panic disorder work? An uncontrolled case study. J Anxiety Disord. 1997 Sep-Oct;11(5):541-56. doi: 10.1016/s0887-6185(97)00030-3.
PubMed 9407272Craske MG, Barlow DH. Mastery of Your Anxiety and Panic: Therapist Guide. Published online 2006. doi:10.1093/med:psych/9780195311402.001.0001
Margraf J, Barlow DH, Clark DM, Telch MJ. Psychological treatment of panic: work in progress on outcome, active ingredients, and follow-up. Behav Res Ther. 1993 Jan;31(1):1-8. doi: 10.1016/0005-7967(93)90036-t.
PubMed 8093337Telch MJ, Lucas JA, Schmidt NB, Hanna HH, LaNae Jaimez T, Lucas RA. Group cognitive-behavioral treatment of panic disorder. Behav Res Ther. 1993 Mar;31(3):279-87. doi: 10.1016/0005-7967(93)90026-q.
PubMed 8476402Ley R. Blood, breath, and fears: A hyperventilation theory of panic attacks and agoraphobia. Clin Psychol Rev. 1985;5(4):271-285.
Studer RK, Danuser B, Hildebrandt H, Arial M, Wild P, Gomez P. Hyperventilation in anticipatory music performance anxiety. Psychosom Med. 2012 Sep;74(7):773-82. doi: 10.1097/PSY.0b013e31825e3578. Epub 2012 Jul 23.
PubMed 22826290Kaplan A, Mannarino AP, Nickell PV. Evaluating the Impact of Freespira on Panic Disorder Patients' Health Outcomes and Healthcare Costs within the Allegheny Health Network. Appl Psychophysiol Biofeedback. 2020 Sep;45(3):175-181. doi: 10.1007/s10484-020-09465-0.
PubMed 32342249Meuret AE, Wilhelm FH, Ritz T, Roth WT. Feedback of end-tidal pCO2 as a therapeutic approach for panic disorder. J Psychiatr Res. 2008 Jun;42(7):560-8. doi: 10.1016/j.jpsychires.2007.06.005. Epub 2007 Aug 3.
PubMed 17681544
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Training in the Treatment of Transdiagnostic Pathological Anxiety: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05427708
- Acronym / sponsor ID
- STUDY00002306
- Conditions
- Anxiety Disorders, Trauma, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Illness Anxiety Disorder
- Keywords
- Psychoeducation, Respiratory training, Transdiagnostic, Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Freespira, Inc.
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Capnometry-Guided Respiratory Intervention (CGRI) | Experimental | Device: Capnometry-Guided Respiratory InterventionIf 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. |
| Psycho-Education (PsyEd) | Active comparator | Behavioral: Psycho-EducationIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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.
Key exclusion criteria (13 listed)
- No history of medical conditions that would contraindicate participation in fear-provocation or respiratory challenges, including:
- Not currently receiving other psychological treatment for anxiety.
- No history of a suicide attempt within the past 6 months.
- No history of psychosis within the past 6 months.
- No history of moderate to severe alcohol or substance use disorder (with the exception of nicotine) within the past 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capnometry-Guided Respiratory InterventionAlso: CGRISee: Arm/group descriptions | Device | Capnometry-Guided Respiratory Intervention (CGRI) |
| Psycho-EducationAlso: PsyEdSee: Arm/group descriptions | Behavioural | Psycho-Education (PsyEd) |
Primary outcome
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.
4 secondary outcomes
Sheehan Disability Scale
Time frame: Pre-Treatment (Week 0), Weekly Assessments (Weeks 1 - 4), Post-treatment (Week 5), 2-Month Follow-Up (Week 13)
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)
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)
Modified DIAMOND
Time frame: Pre-Treatment (Week 0), 2-Month Follow-Up (Week 13)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 3947307Reiss S, Peterson RA, Gursky DM, McNally RJ. Anxiety sensitivity, anxiety frequency and the prediction of fearfulness. Behav Res Ther. 1986;24(1):1-8. doi: 10.1016/0005-7967(86)90143-9. No abstract available.
- Background: PubMed 17307932Li W, Zinbarg RE. Anxiety sensitivity and panic attacks: a 1-year longitudinal study. Behav Modif. 2007 Mar;31(2):145-61. doi: 10.1177/0145445506296969.
- BackgroundMaller RG, Reiss S. Anxiety sensitivity in 1984 and panic attacks in 1987. J Anxiety Disord. 1992;6(3):241-247.
- Background: PubMed 10466277Schmidt NB, Lerew DR, Jackson RJ. Prospective evaluation of anxiety sensitivity in the pathogenesis of panic: replication and extension. J Abnorm Psychol. 1999 Aug;108(3):532-7. doi: 10.1037//0021-843x.108.3.532.
- Background: PubMed 23117637Telch MJ, Rosenfield D, Lee HJ, Pai A. Emotional reactivity to a single inhalation of 35% carbon dioxide and its association with later symptoms of posttraumatic stress disorder and anxiety in soldiers deployed to Iraq. Arch Gen Psychiatry. 2012 Nov;69(11):1161-8. doi: 10.1001/archgenpsychiatry.2012.8.
- BackgroundCobb AR, Lancaster CL, Meyer EC, Lee HJ, Telch MJ. Pre-deployment trait anxiety, anxiety sensitivity and experiential avoidance predict war-zone stress-evoked psychopathology. Journal of Contextual Behavioral Science. 2017;6(3):276-287.
- BackgroundSchmidt NB, Telch MJ. Role of fear of fear and safety information in moderating the effects of voluntary hyperventilation. Behav Ther. 1994;25(2):197-208.
- Background: PubMed 9407272Beck JG, Shipherd JC, Zebb BJ. How does interoceptive exposure for panic disorder work? An uncontrolled case study. J Anxiety Disord. 1997 Sep-Oct;11(5):541-56. doi: 10.1016/s0887-6185(97)00030-3.
- BackgroundCraske MG, Barlow DH. Mastery of Your Anxiety and Panic: Therapist Guide. Published online 2006. doi:10.1093/med:psych/9780195311402.001.0001
- Background: PubMed 8093337Margraf J, Barlow DH, Clark DM, Telch MJ. Psychological treatment of panic: work in progress on outcome, active ingredients, and follow-up. Behav Res Ther. 1993 Jan;31(1):1-8. doi: 10.1016/0005-7967(93)90036-t.
- Background: PubMed 8476402Telch MJ, Lucas JA, Schmidt NB, Hanna HH, LaNae Jaimez T, Lucas RA. Group cognitive-behavioral treatment of panic disorder. Behav Res Ther. 1993 Mar;31(3):279-87. doi: 10.1016/0005-7967(93)90026-q.
- BackgroundLey R. Blood, breath, and fears: A hyperventilation theory of panic attacks and agoraphobia. Clin Psychol Rev. 1985;5(4):271-285.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shristi Saraff contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capnometry-Guided Respiratory Intervention and Psycho-Education in people with Anxiety Disorders and Trauma, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J Telch, PhD (512-814-5480, telch@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427708, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.