Exposure-Based Therapy for Anxiety Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Bipolar, Psychotic, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 13 weeks

600 Participants Needed

Trial Summary

What is the purpose of this trial?

Anxiety-, obsessive-compulsive and trauma- and stressor-related disorders reflect a significant public health problem. This study is designed to evaluate the predictive power of a novel biomarker based on a CO2 challenge, thus addressing the central question "can this easy-to-administer assay aid clinicians in deciding whether or not to initiate exposure-based therapy?"

Will I have to stop taking my current medications?

If you have been stable on your current medication regimen for at least 8 weeks before the screening, you can continue taking them during the trial.

What data supports the effectiveness of the treatment Exposure-Based Therapy for Anxiety Disorders?

Research shows that exposure therapy is effective for treating anxiety-related disorders, including PTSD and panic disorder with agoraphobia. It helps many people, although not everyone experiences full relief, and it is considered one of the most effective treatments for anxiety and related conditions. ^{1 2 3 4 5}

Is exposure-based therapy safe for treating anxiety disorders?

Exposure-based therapy is considered safe when applied as directed by experienced therapists, with strong support from well-controlled studies, especially for conditions like PTSD. ^{2 6 7 8 9}

How is exposure-based therapy different from other treatments for anxiety disorders?

Exposure-based therapy is unique because it involves facing anxiety-inducing situations directly, rather than avoiding them, which helps reduce fear over time. Unlike some other treatments, it focuses on gradually increasing exposure to the source of anxiety to help patients build tolerance and reduce their symptoms. ^{2 4 7 10 11}

Research Team

Jasper Smits, Ph.D.

Principal Investigator

The University of Texas at Austin

Michael Otto, PhD

Principal Investigator

Boston University

Eligibility Criteria

Adults aged 18-70 with anxiety, OCD, or PTSD who can consent and follow the study plan. They must speak English and have a certain level of anxiety. Those stable on meds for at least 8 weeks may join; however, people with bipolar/psychotic disorders, recent substance/eating disorders, serious cognitive issues, or conditions that make CO2 challenges unsafe cannot participate.

Inclusion Criteria

Are you above the age of 18 years old?

Are you able to attend 12 weekly in-person sessions at the University of Texas at Austin?

Do you have a diagnosis of panic disorder (with or without an agoraphobia diagnosis), social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder?

Exclusion Criteria

Do you have any of the following: cardiac arrhythmia, cardiac failure, asthma, lung fibrosis, high blood pressure, epilepsy, or stroke?

Are you currently pregnant or lactating?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CO2 Reactivity Assessment

Participants undergo CO2 reactivity assessment to evaluate biomarker predictive power for exposure-based therapy non-response

1 week

1 visit (in-person)

Treatment

Participants receive open, state-of-the-art, transdiagnostic exposure-based therapy

13 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Follow-up visits (in-person)

Treatment Details

Interventions

• Exposure-Based Therapy

Trial Overview The trial is testing if a simple CO2 challenge can predict who won't respond well to exposure-based therapy for various anxiety-related conditions. It aims to help clinicians decide whether this type of therapy should be started.

Participant Groups

Group I: Open Exposure-Based Therapy (EBT) Experimental Treatment 1 Intervention

All participants will receive a well-established psychological treatment.

Exposure-Based Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Exposure Therapy for:

• Anxiety disorders
• Obsessive-compulsive disorder
• Posttraumatic stress disorder
• Trauma- and stressor-related disorders

Approved in European Union as Exposure-Based Psychotherapy for:

• Anxiety disorders
• Obsessive-compulsive disorder
• Posttraumatic stress disorder
• Trauma- and stressor-related disorders

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

In a study of 231 Veterans undergoing an 8-week modified prolonged exposure therapy for PTSD, most participants (n = 190) did not respond positively to the treatment, indicating that this modified approach may not be effective for many individuals.

The only significant predictor of treatment success was baseline anxiety levels, with nonresponders showing higher anxiety symptoms and lower social support compared to responders, suggesting that those with higher anxiety may need different treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors and Outcomes of Growth Mixture Modeled Trajectories Across an Exposure-Based PTSD Intervention With Veterans. Allan, NP., Gros, DF., Myers, US., et al.[2019]

Exposure therapy is effective for treating anxiety-related disorders, but many patients do not achieve complete symptom relief, and fear can return after treatment.

Recent research highlights that cognitive changes, such as belief modification and reduced avoidance behaviors, along with increased activation in prefrontal brain regions, are key mechanisms that enhance the effectiveness of exposure therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of Action in Exposure Therapy. Knowles, KA., Tolin, DF.[2023]

The scoping review identified and classified various strategies to improve access to cognitive-behavioral therapy (CBT) for anxiety disorders, including enhancing the evidence base, identifying effective delivery methods, and engaging potential service users.

The review emphasizes the need for more comprehensive implementation research to address gaps in access to evidence-based psychological treatments, ensuring that strategies are tailored to local needs and effectively operationalized.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to improve access to cognitive behavioral therapies for anxiety disorders: A scoping review. Carrier, JD., Gallagher, F., Vanasse, A., et al.[2022]

A study involving 125 eating disorder providers found that framing exposure therapy as a 'behavioral experiment' increased the likelihood of providers endorsing its use compared to framing it as traditional exposure or acceptance-based therapy.

Providers with more specialized training in eating disorder exposure therapy were more inclined to use exposure methods, suggesting that improved training and clear communication about the benefits of exposure therapy could enhance its adoption in treating eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulating the theoretical framing of exposure therapy for eating disorders impacts clinicians' treatment preferences. Levinson, CA., Christian, C., Vanzhula, IA.[2021]

In a study of 73 psychiatric outpatients with panic disorder and agoraphobia, both Exposure in vivo (E) and Cognitive Behavior Therapy (CBT) led to significant improvements in anxiety, depression, and quality of life, with benefits maintained at a 1-year follow-up.

There was no significant difference in effectiveness between Exposure therapy and Cognitive Behavior Therapy, suggesting that exposure alone is as effective as combining it with cognitive strategies for treating panic disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy vs exposure in vivo in the treatment of panic disorder with agoraphobia (corrected from agrophobia). Ost, LG., Thulin, U., Ramnerö, J.[2018]

Exposure therapy is the most effective psychological intervention for anxiety disorders but is underutilized in clinical practice due to its poor public perception.

A new term, 'Supported Approach of Feared Experiences - Cognitive Behavioral Therapy (SAFE-CBT)', was preferred by clinicians for patient communication, suggesting that rebranding could help increase the adoption of exposure therapy in treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It's all in the name: why exposure therapy could benefit from a new one. Becker-Haimes, EM., Stewart, RE., Frank, HE.[2022]

Exposure treatment is an effective therapy for various anxiety disorders, including agoraphobia, social phobia, compulsive disorder, and post-traumatic stress disorder, by encouraging patients to confront their fears directly.

The method is straightforward enough for general practitioners to learn and implement, yet it is underutilized in clinical practice, suggesting a need for greater awareness and training in this therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exposure therapy for anxiety disorders in a psychiatric ward]. Irgens, A.[2008]

A study involving 100 registered psychologists in Australia identified key barriers to the use of exposure therapy for treating anxiety, OCD, and PTSD, including lack of confidence and negative beliefs about the therapy.

Addressing these barriers through additional training and supervision could enhance the implementation of exposure therapy, which is considered a gold standard treatment for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to the use of exposure therapy by psychologists treating anxiety, obsessive-compuslive disorder, and posttraumatic stress disorder in an Australian sample. Moses, K., Gonsalvez, CJ., Meade, T.[2023]

Exposure therapy is a safe and effective treatment for Posttraumatic Stress Disorder (PTSD), supported by strong evidence from well-controlled studies across various trauma populations.

Despite its effectiveness, misconceptions about exposure therapy may hinder its broader acceptance, highlighting the importance of proper application by experienced therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure therapy for posttraumatic stress disorder. Rothbaum, BO., Schwartz, AC.[2018]

Exposure therapies for anxiety disorders have been proven effective for over 50 years, yet many patients still do not receive these treatments, often only engaging in talk therapy and relaxation techniques.

The disconnect between the efficacy of exposure-based treatments and their accessibility highlights a significant public health issue, prompting a need for better dissemination and implementation strategies to ensure patients can confront their fears directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of empirically supported treatments for anxiety disorders: introduction to the special issue. Powers, MB., Deacon, BJ.[2021]

Vagus nerve stimulation (VNS) can enhance the generalization of fear extinction in rats, allowing them to show reduced fear responses to stimuli not directly presented during treatment, suggesting it could improve exposure-based therapies.

In addition to promoting extinction generalization, VNS also significantly reduced anxiety in rats, as evidenced by increased time spent in the open arms of an elevated plus maze, indicating its potential as an adjunctive treatment for anxiety-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation promotes generalization of conditioned fear extinction and reduces anxiety in rats. Noble, LJ., Meruva, VB., Hays, SA., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictors and Outcomes of Growth Mixture Modeled Trajectories Across an Exposure-Based PTSD Intervention With Veterans. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Mechanisms of Action in Exposure Therapy. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Strategies to improve access to cognitive behavioral therapies for anxiety disorders: A scoping review. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Manipulating the theoretical framing of exposure therapy for eating disorders impacts clinicians' treatment preferences. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy vs exposure in vivo in the treatment of panic disorder with agoraphobia (corrected from agrophobia). [2018]

6. United States pubmed.ncbi.nlm.nih.gov

It's all in the name: why exposure therapy could benefit from a new one. [2022]

7. Norway pubmed.ncbi.nlm.nih.gov

[Exposure therapy for anxiety disorders in a psychiatric ward]. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

Barriers to the use of exposure therapy by psychologists treating anxiety, obsessive-compuslive disorder, and posttraumatic stress disorder in an Australian sample. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Exposure therapy for posttraumatic stress disorder. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Dissemination of empirically supported treatments for anxiety disorders: introduction to the special issue. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation promotes generalization of conditioned fear extinction and reduces anxiety in rats. [2020]