Cognitive Behavioral Therapy for Social Anxiety Disorder

(I-FOCUS Trial)

Overseen By Angela Fang, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Psychotropic medications

Disqualifiers: Manic, Psychotic, Neurological, ADHD, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some people fully benefit from cognitive behavioral therapy (CBT) for social anxiety disorder while others do not. Participants will attend twelve weekly sessions of CBT, a type of talk therapy that helps change negative thought patterns. The trial seeks individuals between 18 and 45 years old who have social anxiety or body dysmorphic disorder and are seeking treatment. Participants must be fluent in English and willing to consent to join the study. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future treatment strategies.

Will I have to stop taking my current medications?

The trial requires that participants stop taking psychotropic medications, except for antidepressants, which must be taken at a stable dose for at least 3 months before starting the study.

What prior data suggests that cognitive behavioral therapy is safe for treating social anxiety disorder?

Research has shown that Cognitive Behavioral Therapy (CBT) safely treats various mental health issues. It effectively helps individuals manage problems like anxiety and stress. CBT works by altering negative thoughts and behaviors, which can reduce anxiety over time.

No reports of serious side effects from CBT exist. Most individuals tolerate it well, and since it doesn't involve medication, it has fewer side effects than drug treatments. This makes it a safe option for many seeking to improve their mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cognitive Behavioral Therapy (CBT) is unique because it offers a structured approach to treating Social Anxiety Disorder by helping individuals identify and change negative thought patterns and behaviors. Unlike medications, which typically aim to manage symptoms, CBT empowers individuals to develop coping skills that can lead to long-term improvements and potentially reduce the need for medication. Researchers are excited about CBT because it emphasizes personal growth and resilience, offering a non-pharmacological option that can be tailored to each person's specific challenges and experiences.

What evidence suggests that cognitive behavioral therapy is effective for social anxiety disorder?

Studies have shown that cognitive behavioral therapy (CBT), which participants in this trial will receive, effectively reduces symptoms of social anxiety disorder (SAD). Reviews combining results from multiple studies confirm CBT's success in treating SAD. Research indicates that symptoms can decrease significantly after therapy, with noticeable improvements continuing for up to a year or more. Effect sizes, ranging from 0.9 to 1.2, measure the strength of CBT's impact, demonstrating a strong positive effect. Overall, research supports CBT as a helpful treatment for reducing social anxiety symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Angela Fang, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like Body Dysmorphic Disorder, Social Anxiety Disorder, or Generalized Anxiety Disorder. It aims to understand why Cognitive Behavioral Therapy (CBT) works well for some but not others.

Exclusion Criteria

I am only taking antidepressants at a stable dose for the last 3 months.

I have tried cognitive behavioral therapy without success or am currently undergoing it.

Score < 80 based on WRAT5 Word Reading Subtest

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-treatment

Baseline assessments including neuroimaging scans, clinical interviews, and self-report assessments

2 weeks

1 visit (in-person)

Treatment

Participants receive 12 weekly sessions of individual cognitive behavioral therapy and complete 4 fMRI scans

12 weeks

12 visits (in-person)

Post-treatment

Post-treatment assessments including neuroimaging scans and clinical interviews

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy

Trial Overview

The study investigates the effectiveness of Cognitive Behavioral Therapy in treating various anxiety-related disorders by examining brain activity, cognitive function, clinical evaluations, and personal reports from participants.

How Is the Trial Designed?

Group I: Cognitive behavioral therapy Experimental Treatment 1 Intervention

Twelve weekly sessions of individual cognitive behavioral therapy

Cognitive Behavioral Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in United States as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)
• Substance use disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Anxiety disorders
• Depressive disorders
• Eating disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Cognitive techniques play a crucial role in the treatment of social phobia, especially when combined with behavioral methods like exposure therapy and social skills training, enhancing overall treatment effectiveness.

Cognitive-behavioral treatment for social phobia shows promise for long-term maintenance of therapeutic gains, suggesting it may be a sustainable option compared to pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific issues in the cognitive-behavioral treatment of social phobia. Heimberg, RG.[2018]

Cognitive behavioral group therapy (CBGT) and mindfulness-based stress reduction (MBSR) both significantly reduced negative emotions in patients with social anxiety disorder (SAD) over a 12-week treatment period, with no significant differences between the two therapies.

Both treatments led to increased brain activity in regions associated with cognitive reappraisal and attention regulation, suggesting that they may enhance emotion regulation strategies effectively, with lasting benefits observed one year post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Cognitive Behavioral Therapy vs Mindfulness Meditation in Brain Changes During Reappraisal and Acceptance Among Patients With Social Anxiety Disorder: A Randomized Clinical Trial. Goldin, PR., Thurston, M., Allende, S., et al.[2022]

The claim that cognitive-behavioral therapy (CBT) is superior to other psychotherapies is undermined by small and mostly nonsignificant effect sizes, suggesting that the benefits of CBT may not be as strong as previously thought.

Issues such as the focus on specific symptoms rather than overall psychological functioning, classification problems in treatment types, and the inclusion of biased trials contribute to the weak evidence supporting CBT's superiority.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In pursuit of truth: A critical examination of meta-analyses of cognitive behavior therapy. Wampold, BE., Flückiger, C., Del Re, AC., et al.[2019]

Mindfulness and acceptance-based group therapy (MAGT) and cognitive behavioral group therapy (CBGT) were both found to be effective in reducing social anxiety symptoms in individuals with Social Anxiety Disorder (SAD), based on a study of 137 participants.

There was no significant difference in effectiveness between MAGT and CBGT, suggesting that both therapies are viable options for treating SAD, and further research is needed to understand how these treatments facilitate change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness and acceptance-based group therapy versus traditional cognitive behavioral group therapy for social anxiety disorder: a randomized controlled trial. Kocovski, NL., Fleming, JE., Hawley, LL., et al.[2022]

Emotion Regulation Therapy (ERT) was effective in treating social anxiety disorder (SAD) in four clients who also had symptoms of generalized anxiety disorder (GAD) and depression, showing significant improvements in symptom severity and quality of life after 16 sessions.

The positive effects of ERT were maintained or even increased during follow-up assessments at 1, 2, and 3 months, suggesting that ERT may address underlying issues of emotion dysregulation and motivation in individuals with co-morbid SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation therapy for social anxiety disorder: a single case series study. Abasi, I., Pourshahbaz, A., Mohammadkhani, P., et al.[2021]

In a study of 108 participants with social anxiety disorder, cognitive-behavioral group therapy (CBGT) was found to be more effective than mindfulness-based stress reduction (MBSR) for individuals with higher levels of anger suppression, leading to greater reductions in social anxiety.

Conversely, higher anger expression was linked to less reduction in social anxiety during MBSR, suggesting that individuals with SAD who struggle with anger might benefit more from CBGT than MBSR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The moderating effects of anger suppression and anger expression on cognitive behavioral group therapy and mindfulness-based stress reduction among individuals with social anxiety disorder. Kuo, JR., Zeifman, RJ., Morrison, AS., et al.[2021]

Short-term effectiveness was found for non-drug treatments like social skills training, exposure therapy, and cognitive therapy in managing social phobia, with a combination of exposure and cognitive therapy showing potential superiority.

While therapies led to stable results over follow-up periods, more research is needed to compare cognitive behavior therapy with medication and to explore the effectiveness of self-help manuals in treatment combinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-drug treatment for social phobia. van Dyck, R.[2019]

Cognitive-behavioral therapies (CBTs) are the most researched and effective psychotherapeutic interventions for adults with social anxiety disorder, showing consistent benefits across various forms of CBT.

There are also effective pharmacological treatments available, and while CBTs have shown efficacy for children and adolescents, further research is needed to understand treatment responses and the potential benefits of combining CBT with medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of social anxiety disorder. Rodebaugh, TL., Holaway, RM., Heimberg, RG.[2018]

Cognitive Behaviour Therapy (CBT) was found to be more effective than Supportive Therapy (ST) in treating social phobia, with significant improvements observed after just 6 weeks of individual cognitive therapy and continued benefits after social skills training.

Both treatment groups showed sustained improvements over time, but CBT demonstrated long-lasting effects, suggesting that effective management of social phobia may require more comprehensive psychological interventions rather than simpler approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy versus supportive therapy in social phobia: a randomized controlled trial. Cottraux, J., Note, I., Albuisson, E., et al.[2018]

Recent advances in cognitive-behavioral therapy (CBT) for social phobia have led to the development of a new psychobiological model, enhancing understanding and treatment of the condition.

Controlled clinical trials have shown that the authors' CBT approach is effective, and future research will explore combining drug therapy with behavioral therapy and intensive treatments for avoidant personality disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in cognitive-behavioral therapy for social phobia. Heimberg, RG., Barlow, DH.[2018]

Cognitive-behavioral therapy (CBT) is effective for treating social anxiety disorder (SAD), with individual cognitive therapy showing the largest effect sizes among various CBT approaches.

Recent research highlights the importance of emotion regulation and fear extinction in achieving positive treatment outcomes, and internet-delivered CBT offers a promising way to increase access to these effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Developments in Cognitive-Behavioral Therapy for Social Anxiety Disorder. Stangier, U.[2018]

Cognitive-behavioral treatment (CBT) is effective for many patients with social phobia, but some do not respond well, prompting research into enhanced techniques to improve outcomes.

The paper discusses tailored CBT techniques, such as safety behavior experiments and social skills training, which are designed to address individual patient needs and may lead to better treatment results for those with social phobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment of social phobia: new advances. Huppert, JD., Roth, DA., Foa, EB.[2019]

Cognitive-behavioral therapy (CBT) for social anxiety disorder focuses on cognitive restructuring and exposure interventions, which have been shown to lead to both immediate improvements and sustained benefits over time.

The review highlights the effectiveness of these CBT strategies based on individual studies and meta-analyses, suggesting that they are crucial for understanding and treating social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for social anxiety disorder: model, methods, and outcome. Otto, MW.[2018]

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