What side effects are associated with this type of intervention?

Common treatments for Social Anxiety Disorder (SAD) include cognitive-behavioral therapy (CBT), selective serotonin reuptake inhibitors (SSRIs), and benzodiazepines. CBT, which is similar to Attention Bias Modification Treatment (ABMT) in its non-pharmacological approach, generally has minimal side effects but may cause temporary increases in anxiety as patients confront feared situations. SSRIs, often used to treat SAD, can cause side effects such as nausea, insomnia, and sexual dysfunction. Benzodiazepines, another pharmacological option, may lead to drowsiness, dependence, and withdrawal symptoms. ABMT, being a newer treatment, has not been associated with significant side effects, making it a potentially safer alternative.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Social Anxiety Disorder, including selective serotonin reuptake inhibitors (SSRIs) such as paroxetine and sertraline, and the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine. These medications work by altering neurotransmitter levels to reduce anxiety symptoms. While these treatments do not specifically target attention bias towards social threat like ABMT, they are effective in managing the overall symptoms of social anxiety.

What other types of research exist?

Promising novel alternatives to ABMT for Social Anxiety Disorder patients include: 1) Mindfulness-Based Interventions, which have shown benefits in reducing anxiety and improving quality of life; 2) Cognitive-Behavioral Therapy (CBT), particularly digital or online CBT, which has demonstrated efficacy in treating anxiety disorders; and 3) Pharmacotherapy options such as selective serotonin reuptake inhibitors (SSRIs) or newer medications like lisdexamfetamine, which have been effective in reducing anxiety symptoms. These alternatives offer different mechanisms and approaches that can be tailored to individual patient needs.

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ABMT for Social Anxiety Disorder

N/A

Recruiting

Led By Jeremy W Pettit, PhD

Research Sponsored by Florida International University

Eligibility Criteria Checklist

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

Must have

Have no current psychotropic medication other than a stable dose of stimulant or non-stimulant medication for coexisting ADHD

Be between ages 10 and 14 years

Must not have

Have a history of neurological illness, including seizures/epilepsy, or head injury with loss of consciousness > 5 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow-up (six months after completing the final treatment session)

Summary

This trial tests a computer-based therapy called ABMT on kids aged 10-14 with social anxiety. The therapy aims to help them focus less on negative social cues, which may reduce their anxiety. Researchers will compare brain activity and anxiety levels between those who get ABMT and those who do not. Attention Bias Modification Treatment (ABMT) is a novel computer-based treatment for anxiety disorders, proposed as an efficient and accessible psychological therapy.

Who is the study for?

This trial is for youths aged 10-14 with Social Anxiety Disorder, without severe other psychiatric conditions or current psychotropic medication (except for stable ADHD treatment). They must not have a history of neurological illness, significant head injury, uncorrected vision or physical disabilities affecting mouse use, nor meet criteria for certain other disorders.

What is being tested?

The study tests Attention Bias Modification Treatment (ABMT) against a Neutral Control Task (NCT) in reducing social anxiety. Participants will be randomly assigned to receive one of the two computer-based treatments over eight sessions. The effectiveness will be measured using EEG and social anxiety severity ratings.

What are the potential side effects?

Since ABMT and NCT are non-invasive computer tasks focusing on attention training, they typically do not have direct side effects like medications. However, participants may experience fatigue or frustration during the tasks.

Eligibility Criteria

Inclusion Criteria

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

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I am only taking medication for ADHD and nothing else for mental health.

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I am between 10 and 14 years old.

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I have been diagnosed with Social Anxiety Disorder.

Exclusion Criteria

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

Select...

I have had a neurological illness, seizures, epilepsy, or a significant head injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-intervention (within one week of completing the final treatment session)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-intervention (within one week of completing the final treatment session)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention (within one week of completing the final treatment session) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

P1 amplitude elicited in the dot-probe task

Secondary study objectives

Liebowitz Social Anxiety Scale for Children and Adolescents

Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up

Screen for Child Anxiety Related Emotional Disorders - Child Version at posttreatment

+2 more

Other study objectives

State Anxiety before and after a Speech Task

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Attention Bias Modification TreatmentExperimental Treatment1 Intervention

Attention Bias Modification Treatment is a computer-based attention training program.

Group II: Neutral Control TaskPlacebo Group1 Intervention

Neutral Control Task uses the same computer-based format as Attention Bias Modification Treatment, but includes only neutral stimuli and does not train attention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Attention Bias Modification Treatment

2010

N/A

~120

0 / 4Eligibility 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 Social Anxiety Disorder (SAD) include cognitive-behavioral therapy (CBT) and Attention Bias Modification Treatment (ABMT). CBT works by challenging and changing unhelpful thoughts and behaviors, improving emotional regulation, and developing better coping strategies. ABMT specifically targets the attention bias towards social threats, a core feature of SAD. By reducing this bias, ABMT can potentially lower the severity of social anxiety symptoms. Understanding these mechanisms is crucial for patients as it highlights how these treatments can directly address the underlying cognitive processes that maintain their anxiety, leading to more effective and targeted interventions.

Attention bias modification treatment augmenting effects on cognitive behavioral therapy in children with anxiety: randomized controlled trial.