80 Participants NeededMy employer runs this trial

Computer-Based Treatment for Social Anxiety Disorder

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Overseen ByFranklin Schneier, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: New York State Psychiatric Institute
Must be taking: SSRIs
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 tests a new computer-based treatment for social anxiety disorder (SAD). The researchers aim to evaluate its effectiveness and user-friendliness compared to another computer-based approach. Participants will engage in eight sessions over four weeks to assess improvements in anxiety symptoms. Individuals dealing with social anxiety, who have a primary diagnosis of SAD, and are fluent in English may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could shape future treatments for social anxiety disorder.

Will I have to stop taking my current medications?

The trial requires that you have not used psychiatric medication in the past month, except for a stable dose of SSRIs (a type of antidepressant) for at least 3 months. If you are on other psychiatric medications, you may need to stop them before participating.

What prior data suggests that this computer-based therapy is safe for individuals with social anxiety disorder?

Past studies have found computer-based treatments for various conditions to be safe and easy to manage. Research shows these therapies can monitor patient safety in real-time, reducing risks. The technology aims to prevent mistakes and quickly address any issues.

For the computer-based treatment being tested for social anxiety disorder, specific safety data is not yet available. However, the study's "Not Applicable" phase likely indicates testing for effectiveness and acceptability. Early-stage treatments typically focus on ensuring participant safety.

Although no specific issues have been reported for this treatment, the overall safety and monitoring features of computer-based therapies suggest they are safe. Participants can expect a secure environment as researchers closely monitor their well-being throughout the trial.12345

Why are researchers excited about this trial?

Unlike traditional therapies for social anxiety disorder, which often involve face-to-face sessions with a therapist, this computer-based treatment offers a unique, digital approach. Researchers are excited about these treatments because they enhance accessibility, allowing patients to receive therapy from the comfort of their own homes. Additionally, the structured 4-week, 8-session format provides a consistent and efficient schedule, potentially offering quicker relief than more drawn-out therapies. This innovative method could revolutionize how we manage social anxiety by making treatment more convenient and reducing barriers to care.

What evidence suggests that this computer-based treatment might be an effective treatment for social anxiety disorder?

Research shows that computer-delivered therapy can effectively reduce anxiety and depression symptoms. A review of 22 studies found it effective and generally well-received by participants. This trial will compare two different computer-based treatments. One group will receive an experimental computer-based treatment, while the other will receive a comparator computer-based treatment. Additionally, studies have shown that computer-assisted cognitive behavioral therapy (CBT) can significantly reduce depression. Growing evidence indicates that online therapy tools help manage various mental health issues. Overall, these findings suggest that computer-based therapy might also benefit people with social anxiety disorder.678910

Who Is on the Research Team?

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FRANKLIN SCHNEIER, MD

Principal Investigator

New York State Psychiatric Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 who have social anxiety disorder, speak English fluently, can give written consent, and have normal or corrected vision. People with certain mental health conditions, unstable medical illnesses, metal implants not safe for MRI scans, recent psychotherapy changes, pregnancy plans, or severe substance use cannot join.

Inclusion Criteria

Males and females between the ages of 18 to 60
You have metal implants or devices that prevent you from safely undergoing magnetic resonance imaging (MRI).
Fluent in English
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Exclusion Criteria

You have thoughts or behaviors of wanting to harm yourself.
You have been taking medication for mental health, except for a stable dose of a type called selective serotonin reuptake inhibitors (SSRIs) for at least 3 months.
Inability to tolerate MRI scanning procedures (i.e., severe obesity, claustrophobia)
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 4-week (8-session) course of computer-based treatment for social anxiety disorder, with sessions twice a week

4 weeks
8 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of social anxiety and quality of life

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Computer-Based Treatment

Trial Overview

The study tests a new computer-based therapy designed to help people with social anxiety disorder. Participants will use this digital treatment and the study will measure how well it works compared to usual care in a controlled setting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Computer-Based TreatmentExperimental Treatment1 Intervention
Group II: Comparator Computer-Based TreatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials
481
Recruited
154,000+

Columbia University

Collaborator

Trials
1,529
Recruited
2,832,000+

Mclean Hospital

Collaborator

Trials
221
Recruited
22,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

University of Texas

Collaborator

Trials
193
Recruited
143,000+

Tel Aviv University

Collaborator

Trials
178
Recruited
23,800+

Citations

Computer-based interventions for drug use disorders - PMC

Computer-based interventions for drug use disorders show initial evidence of efficacy during treatment and some evidence that effects continue after treatment.

Computer therapy for the anxiety and depression disorders ...

A 2010 meta-analysis, based on 22 randomised controlled trials, argued that computer therapy for the anxiety and depressive disorders was effective, acceptable ...

Effectiveness For Online Cognitive Behavioral Therapy ...

There is growing evidence that online self-management tools based on psychotherapy models are effective with various forms of psychic distress.

Effect of Computer-Assisted Cognitive Behavior Therapy vs ...

In this randomized clinical trial of 175 adults, CCBT reduced depression, as measured by the Patient Health Questionnaire–9, to a significantly greater extent ...

Computer-, smartphone-based treatments effective at ...

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Organization and Representation of Patient Safety Data - PMC

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Hazard Communication Standard: Safety Data Sheets

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Safety Data Sheet (SDS) Access - HSI

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Improving Safety with Information Technology

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