Behavioral Observations for Obsessive-Compulsive Disorder

(ABOVE Trial)

Not currently recruiting at 2 trial locations
GV
CV
Overseen ByCarmen Vasquez
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor College of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how individuals with and without Obsessive-Compulsive Disorder (OCD) respond to certain stress tests by observing their behavior and brain activity. Participants will perform tasks that induce stress, such as the Trier Social Stress Test (TSST), while researchers measure their responses. This approach examines how OCD affects stress reactions differently. Ideal candidates for this trial include those with OCD characterized by contamination and handwashing compulsions, as well as healthy individuals without psychiatric disorders. This research could eventually aid in developing better treatments or understanding of stress-related conditions. As an unphased study, this trial allows participants to contribute to foundational research that may lead to improved treatments for stress-related conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that OCD subjects should be on a stable medication regimen if applicable. It's best to discuss your specific situation with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this study are generally safe based on previous findings. The exposure provocation task, often used in therapy for obsessive-compulsive disorder (OCD), has been found to be well-tolerated and effective in reducing OCD symptoms over time. This task involves briefly facing situations that trigger OCD without performing compulsive actions. While it can be uncomfortable, it is not harmful.

The Provocation OC task is similar, aiming to trigger OCD symptoms to better understand and manage them. Research suggests this method is safe and may enhance the effectiveness of other treatments like transcranial magnetic stimulation (TMS).

The Trier Social Stress Test (TSST) is commonly used to study stress responses. It includes activities like public speaking that can be stressful but are considered safe. This test helps researchers learn how stress affects the body and mind.

Overall, these tasks might cause temporary discomfort or stress but are not known to have long-term negative effects. Their widespread use in research and therapy supports their safety for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the Measuring Automated Behavioral Observations & Vocal Expressions (ABOVE) trial because it explores new ways to understand and assess responses in people with and without OCD. Unlike traditional treatments that typically involve medication or cognitive behavioral therapy, this trial uses tasks like the Provocation OC task and the Trier Social Stress Test to provoke and measure stress and behavioral responses. The goal is to uncover unique patterns in vocal expressions and behavior that could lead to new insights into OCD and stress responses. This innovative approach could pave the way for more personalized and effective treatment strategies in the future.

What evidence suggests that this trial's treatments could be effective for OCD?

This trial will compare the effects of different tasks on participants with and without OCD. Studies have shown that certain activities, such as the Exposure Provocation Task, effectively treat OCD. Patients often experience a significant reduction in OCD symptoms after these treatments, with improvements lasting for at least a year. Participants in this trial will engage in activities that trigger symptoms, similar to the Provocation OC Task, which might enhance the effects of other treatments, such as therapy. This approach may benefit patients who do not respond well to medication or traditional therapy. The Trier Social Stress Test (TSST) is commonly used to induce stress in a controlled environment, aiding researchers in understanding how stress affects OCD symptoms.12678

Who Is on the Research Team?

WG

Wayne Goodman, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

The subject has a minimum score of ≥16 on the Y-BOCS;
If applicable, on a stable pharmacologic regimen;
Sample will be enriched with OCD subjects having contamination obsessions and handwashing compulsions, and scores on items 9 and 10 of the Y-BOCS reflecting difficulty resisting and controlling compulsions;
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Testing Session

Subjects participate in a testing session involving behavioral tasks and brain activity recording

2 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the testing session

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Exposure provocation task
  • Provocation OC task (Provoc)
  • Trier Social Stress Test (TSST)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: OCD subjectsExperimental Treatment3 Interventions
Group II: Control subjectsExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+

Brown University

Collaborator

Trials
480
Recruited
724,000+

Citations

Exposure and response prevention for obsessive-compulsive ...

[4] The first significant nonpharmacological advance in treatment occurred after Meyer[5] reported that patients' OCD symptoms improved when they were exposed ...

The effect of exposure and response prevention therapy on ...

In addition, compared with the control group, ERP reduced depression (g = 0.15) and anxiety symptoms (g = 0.23) in patients with OCD. Meta-regression results ...

Efficacy of exposure and response prevention therapy in ...

Dropout rates in exposure with response prevention for obsessive-compulsive disorder: what do the data really say? J Anxiety Disord. 2016 ...

An outcome study of an intensive, out-patient exposure and ...

Results showed a large and significant decrease in OCD and obsessive beliefs at post-treatment. These improvements were maintained at 12-month ...

Increased Amygdala Activation During Symptom ...

Higher pretreatment task-related activation of the right amygdala to OCD-related stimuli showed a positive association with treatment response ...

A Method to Provoke Obsessive Compulsive Symptoms for ...

Symptom provocation is a brief procedure, inducing a few minutes of doubt while preventing the subject from performing the compulsion on its own ...

Revisiting deficits in threat and safety appraisal ...

Exposure response prevention (ERP) is an established first‐line treatment for OCD and is predicated on learning theory principles of fear conditioning and ...

effects of habituation and expectancy violation on short-term ...

This study aimed to identify mechanisms of exposure with response prevention (ERP) that predict short-term outcomes in CBT for obsessive ...