What is the mechanism of action of this treatment?

Common treatments for Adjustment Disorder include cognitive behavioral therapy (CBT) techniques such as Interoceptive Exposure (IE) and Capnometry-Guided Respiratory Intervention (CGRI). IE involves graduated exposure to somatic cues, which helps patients reduce fear responses to bodily sensations by gradually increasing their tolerance to these sensations. CGRI aims to raise end-tidal CO2 levels, thereby lowering hyperventilation-induced respiratory alkalosis and its associated anxiety symptoms. These mechanisms are crucial for Adjustment Disorder patients as they directly address the physiological and psychological responses to stress, helping to alleviate symptoms and improve overall coping strategies.

What side effects are associated with this type of intervention?

Interoceptive Exposure, which involves graduated exposure to somatic cues, can sometimes lead to temporary increases in anxiety or discomfort as patients confront feared sensations. Capnometry-Guided Respiratory Intervention, aimed at raising end-tidal CO2 levels to counteract hyperventilation, may cause mild dizziness or lightheadedness during the initial stages of treatment. Both therapies are generally well-tolerated, with side effects often diminishing as patients become accustomed to the interventions.

What other types of research exist?

Promising, novel alternatives for treating Adjustment Disorder in 2024 include Cognitive Behavioral Therapy for Insomnia (CBT-I), relaxation techniques such as progressive muscle relaxation and guided imagery, hypnosis, and biofeedback. These therapies have shown efficacy in improving psychological well-being and reducing anxiety and pain, making them potential options for Adjustment Disorder patients.

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Respiratory Training vs Interoceptive Exposure for Anxiety

Q: What prior FDA approvals exist?

The FDA has approved several medications for the treatment of anxiety-related conditions, which can be relevant for Adjustment Disorder. These include selective serotonin reuptake inhibitors (SSRIs) like sertraline and fluoxetine, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine. While specific FDA approvals for Interoceptive Exposure and Capnometry-Guided Respiratory Intervention are not mentioned, these therapies are innovative approaches targeting physiological responses to anxiety. Interoceptive Exposure involves gradual exposure to anxiety-inducing somatic cues to reduce fear responses, and Capnometry-Guided Respiratory Intervention aims to correct hyperventilation-induced respiratory alkalosis by raising end-tidal CO2 levels.

Verified Trial

N/A

Recruiting

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

No current use of psychotropic medications or stable on current medications for at least 3 months

Must not have

Not currently receiving other psychological treatment for anxiety.

No history of a suicide attempt within the past 6 months.

Timeline

Screening 3 days

Treatment 4 weeks

Follow Up 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares three treatments for people with severe anxiety: getting used to scary physical feelings, learning to breathe better, and learning about anxiety. These treatments aim to help those who don't respond well to usual methods or who relapse. The first treatment helps reduce fear of physical sensations, the second helps control breathing to reduce anxiety, and the third provides knowledge about anxiety.

Who is the study for?

This trial is for adults over 18 with anxiety or trauma-related disorders like PTSD, social anxiety, and agoraphobia. Participants should not be on new psychotropic meds or have a recent history of substance abuse, psychosis, or suicide attempts. They must be able to travel to the study site.

What is being tested?

The study compares two treatments for pathological anxiety: Interoceptive Exposure (IE), which involves facing physical sensations that cause fear; Capnometry-Guided Respiratory Intervention (CGRI), which corrects breathing patterns; and Psycho-Education about anxiety as a control group.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from facing fear-inducing sensations in IE, changes in breathing patterns with CGRI, and general distress related to discussing anxiety during PsyEd.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with an anxiety or trauma-related disorder like PTSD or panic disorder.

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I haven't used psychotropic drugs recently or have been stable on them for 3+ months.

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I am 18 years old or older.

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I can get to the lab for my study appointments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently undergoing any treatment for anxiety.

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You have not attempted suicide in the past 6 months.

Timeline

Screening ~ 3 days0 visits

Treatment ~ 4 weeks0 visits

Follow Up ~ 2 months2 visits

Screening ~ 3 days

Treatment ~ 4 weeks

Follow Up ~2 months

This trial's timeline: 3 days for screening, 4 weeks for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Computerized Hamilton Anxiety Scale

Overall Anxiety Severity and Impairment Scale

Secondary study objectives

Anxiety Sensitivity Composite Measure

Modified DIAMOND

PROMIS - Global Health (Mental Health Subdomain)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Interoceptive Exposure (IE)Experimental Treatment1 Intervention

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.

Group II: Capnometry-Guided Respiratory Intervention (CGRI)Experimental Treatment1 Intervention

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.

Group III: Psycho-Education (PsyEd)Active Control1 Intervention

If assigned to the psycho-education condition, participants will undergo once-weekly 20-minute video conferencing session with a therapist for four weeks. 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Adjustment Disorder include cognitive behavioral therapy (CBT) techniques such as Interoceptive Exposure (IE) and Capnometry-Guided Respiratory Intervention (CGRI). IE involves graduated exposure to somatic cues, which helps patients reduce fear responses to bodily sensations by gradually increasing their tolerance to these sensations. CGRI aims to raise end-tidal CO2 levels, thereby lowering hyperventilation-induced respiratory alkalosis and its associated anxiety symptoms. These mechanisms are crucial for Adjustment Disorder patients as they directly address the physiological and psychological responses to stress, helping to alleviate symptoms and improve overall coping strategies.

Relaxation therapy reduces anxiety in child and adolescent psychiatric patients.Cognitive behavioral treatment compared with nonprescriptive treatment of panic disorder.Cue Exposure Therapy for Alcohol Use Disorders: What Can Be Learned from Exposure Therapy for Anxiety Disorders?