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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand why some individuals respond fully to cognitive behavioral therapy and others do not, based on multiple sources of data such as neural, neurocognitive, clinical, and self-report data.

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 data supports the effectiveness of this treatment for social anxiety disorder?

Research shows that cognitive-behavioral therapy (CBT) is effective for treating social anxiety disorder, with strategies like cognitive restructuring and exposure leading to both immediate and long-term improvements. Mindfulness-based stress reduction (MBSR) is also recognized as an evidence-based treatment for social anxiety disorder. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for humans?

Cognitive Behavioral Therapy (CBT) and related therapies like Mindfulness-Based Stress Reduction (MBSR) are generally considered safe for humans, as they are non-invasive and focus on changing thought patterns and behaviors. ^{1 6 7 8 9}

How does Cognitive Behavioral Therapy differ from other treatments for social anxiety disorder?

Cognitive Behavioral Therapy (CBT) is unique because it focuses on changing negative thought patterns and behaviors through techniques like exposure therapy and social skills training, which can lead to long-term improvement. Unlike medication, CBT addresses the root causes of social anxiety and can be delivered in various formats, including individual, group, and even internet-based sessions, making it accessible and adaptable. ^{3 10 11 12 13}

Research Team

Angela Fang, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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.

fMRI contraindications (e.g., electronic medical devices such as pacemakers, implanted defibrillators, metal implants not approved for MRI, pregnancy, claustrophobia)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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 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]

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]

References

1. Netherlands 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. [2021]

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

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

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

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

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

Emotion regulation therapy for social anxiety disorder: a single case series study. [2021]

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

Cognitive-behavioral treatment of social phobia: new advances. [2019]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

In pursuit of truth: A critical examination of meta-analyses of cognitive behavior therapy. [2019]

8. England 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. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy versus supportive therapy in social phobia: a randomized controlled trial. [2018]

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

New developments in cognitive-behavioral therapy for social phobia. [2018]

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

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

12. England pubmed.ncbi.nlm.nih.gov

Non-drug treatment for social phobia. [2019]

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

The treatment of social anxiety disorder. [2018]