Cognitive Behavioral Therapy for Social Anxiety Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Psychotic symptoms, Personality disorder, Substance use, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Cognitive behavioral therapy (CBT) is a brief, efficient, and effective treatment for individuals with depressive/anxiety disorders. However, CBT is largely underutilized within the Department of Veterans Affairs due to the cost and burden of trainings necessary to deliver all of the related disorder-specific treatments (DSTs). Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol in Veterans with depressive/anxiety disorders. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with social anxiety disorder and comorbid posttraumatic stress via a randomized controlled trial of TBT and an existing DST. Assessments will be completed at pre-, mid-, and post-treatment, and at 6-month follow-up. Process variables also will be investigated.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have recently started new psychiatric medications within the last 4 weeks, you may not be eligible to participate.
What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Social Anxiety Disorder?
Research shows that Cognitive Behavioral Therapy (CBT) is highly effective for treating social anxiety disorder, with significant reductions in symptoms observed in various studies. Both individual and group CBT approaches have been shown to reduce social anxiety and related symptoms, and these improvements are often maintained over time.12345
Is Cognitive Behavioral Therapy (CBT) safe for treating social anxiety disorder?
Cognitive Behavioral Therapy (CBT), including its transdiagnostic forms, has been widely studied and is generally considered safe for treating social anxiety disorder and other anxiety-related conditions. Clinical trials and studies have shown that it can effectively reduce symptoms without significant safety concerns.36789
How is Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder different from other treatments?
Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder is unique because it can be delivered in both disorder-specific and transdiagnostic formats, which means it can address multiple anxiety and emotional disorders simultaneously. This flexibility allows it to be effective for people with social anxiety and other co-occurring conditions, offering a comprehensive approach compared to treatments that focus on a single disorder.3581011
Eligibility Criteria
This trial is for Veterans registered at Ralph H. Johnson VA Health Care System who have been diagnosed with social anxiety disorder and also show symptoms of posttraumatic stress. They must be able to give informed consent. Specific details on who can't join are not provided.Inclusion Criteria
Participants must be Veterans and registered at Ralph H. Johnson Veterans Affairs Health Care System
Participants must meet DSM-5 criteria for social anxiety disorder
I understand and can consent to participate in research.
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Exclusion Criteria
Primary diagnosis of a condition associated with psychotic symptoms, personality disorder, substance use disorder, or bipolar disorder.
Acute, severe illness or medical condition that likely will interfere with study procedures as documented in their medical record
I started new psychiatric medication less than 4 weeks ago.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person or virtual)
Treatment
Participants receive either Transdiagnostic Behavior Therapy (TBT) or Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder over 12 weekly sessions
12 weeks
12 visits (in-person or virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month follow-up
6 months
1 visit (in-person or virtual)
Treatment Details
Interventions
- Cognitive Behavioral Therapy for Social Anxiety Disorder (Behavioral Intervention)
- Transdiagnostic Behavior Therapy (Behavioral Intervention)
Trial OverviewThe study compares Transdiagnostic Behavior Therapy (TBT), a versatile treatment for various disorders, with Cognitive Behavioral Therapy (CBT) specifically designed for Social Anxiety Disorder in treating veterans with both conditions.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Transdiagnostic Behavior TherapyExperimental Treatment1 Intervention
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Group II: Cognitive Behavioral Therapy for Social Anxiety DisorderActive Control1 Intervention
To provide an evidence-based comparison for the TBT condition, the research-supported psychological treatment of CBT for SAD will be used. CBT for SAD demonstrates efficacy in improving SAD symptoms and quality of life for patients with SAD, with durable improvements evidenced at follow-up assessments. CBT for SAD was used as a comparison to TBT in previous preliminary research. CBT for SAD involves several primary components, including: 1) psychoeducation, 2) training in cognitive restructuring, 3) exposures, 4) advanced cognitive restructuring, and 5) termination.
Cognitive Behavioral Therapy for Social Anxiety Disorder is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cognitive Behavioral Therapy for:
- Social Anxiety Disorder
- Depressive Disorders
- Anxiety Disorders
- Posttraumatic Stress Disorder
🇪🇺 Approved in European Union as Cognitive Behavioural Therapy for:
- Social Anxiety Disorder
- Depressive Disorders
- Anxiety Disorders
- Posttraumatic Stress Disorder
🇨🇦 Approved in Canada as Cognitive Behavioral Therapy for:
- Social Anxiety Disorder
- Depressive Disorders
- Anxiety Disorders
- Posttraumatic Stress Disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ralph H. Johnson VA Medical Center, Charleston, SCCharleston, SC
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial. [2023]Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT.
Internet-based psychodynamic therapy vs cognitive behavioural therapy for social anxiety disorder: A preference study. [2022]Both Internet-delivered cognitive behavioural therapy (ICBT) and Internet-delivered psychodynamic psychotherapy (IPDT) have shown promise in the treatment of social anxiety disorder (SAD). However, little is known about client preferences and what predicts treatment outcome. The objective of the present pilot study was to examine preference for ICBT versus IPDT in the treatment of SAD and whether participants' preference strength and therapeutic alliance predicted treatment response. Further, we also investigated the effect of the two treatments, including 6-months follow-up.
Transdiagnostic versus disorder-specific and clinician-guided versus self-guided internet-delivered treatment for Social Anxiety Disorder and comorbid disorders: A randomized controlled trial. [2022]Disorder-specific (DS-CBT) and transdiagnostic (TD-CBT) cognitive behaviour therapy have both been used to treat social anxiety disorder (SAD). This study compared internet-delivered DS-CBT and TD-CBT for SAD across clinician-guided (CG-CBT) and self-guided (SG-CBT) formats. Participants with SAD (n=233) were randomly allocated to receive internet-delivered TD-CBT or DS-CBT and CG-CBT or SG-CBT. Large reductions in symptoms of SAD (Cohen's d≥1.01; avg. reduction≥30%) and moderate-to-large reductions in symptoms of comorbid depression (Cohen's d≥1.25; avg. reduction≥39%), generalised anxiety disorder (Cohen's d≥0.86; avg. reduction≥36%) and panic disorder (Cohen's d≥0.53; avg. reduction≥25%) were found immediately post-treatment and were maintained or further improved to 24-month follow-up. No marked differences were observed between TD-CBT and DS-CBT or CG-CBT and SG-CBT highlighting the potential of each for the treatment of SAD and comorbid disorders.
A randomized clinical trial of group and individual Cognitive-Behavioral Therapy approaches for Social Anxiety Disorder. [2020]To compare the effectiveness of two Cognitive-Behavioral Therapy (CBT) interventions-an individual and a group intervention-in Social Anxiety Disorder therapy. We compared the two treatment groups against a waitlist condition in a randomized clinical trial with 86 young adults. The individual CBT intervention was Trial-Based Cognitive Therapy (TBCT) developed by De-Oliveira, a novel technique in which the therapist engages the patient in a simulated judicial trial with the goal of identifying and changing core dysfunctional beliefs. The group intervention consisted of exposition therapy based on the Hofmann and Otto protocol (Group CBT) to restructure negative and dysfunctional cognitions regarding social situations. Both interventions reduced psychiatric symptoms from pre- to post-test and primary social anxiety and depression symptoms relative to waitlist controls. The interventions were recently introduced in Brazil, and this is the first randomized control trial to compare TBCT and this Group CBT, which were effective in assessing changes in social anxiety symptoms as well as co-occurring psychiatric symptoms.
Emotion regulation therapy for social anxiety disorder: a single case series study. [2021]Despite the vast majority of evidence indicating the efficacy of traditional and recent cognitive behaviour therapy (CBT) therapies in treating social anxiety disorder (SAD), some individuals with SAD do not improve by these interventions, particularly when co-morbidity is present.
False Safety Behavior Elimination Therapy: A randomized study of a brief individual transdiagnostic treatment for anxiety disorders. [2022]In response to the ever-growing number of CBT based therapy protocols, transdiagnostic approaches to anxiety treatment, based on models of anxiety emphasizing common elements across anxiety disorders, have been increasingly explored. The aim of the current study was to test the efficacy of an individually administered, brief (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive strategies (so-called "safety" aids) among individuals suffering from a range of anxiety disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and panic disorder (PD). Patients (N=28; mean age=28.5years; 75% female; 71% White) were randomly assigned to F-SET or waitlist control conditions. Participants were assessed prior to, immediately after, and 1-month following treatment. In addition to independent assessments of diagnostic status, standardized self-report measures and assessor ratings of severity and distress associated with anxiety symptoms were used. Participants in the F-SET condition experienced significantly less anxiety (Cohen's d=2.01) and depression (Cohen's d=2.16) than those in the WL condition. Mediational analysis showed that change in avoidance strategies mediated the group changes in anxiety symptoms. The results from the current study are an important first step in identifying a simpler, focused form of CBT that can be delivered with minimal therapist training, at a low cost and with minimal client contact time.
Transdiagnostic versus diagnosis-specific cbt for anxiety disorders: a preliminary randomized controlled noninferiority trial. [2022]Transdiagnostic cognitive-behavioral treatments for anxiety disorders have been gaining increased attention and empirical study in recent years. Despite this, research on transdiagnostic anxiety treatments has, to date, relied on open trials, or comparisons to waitlist conditions, published benchmarks, or relaxation-based interventions.
Transdiagnostic Therapy. [2018]Transdiagnostic cognitive-behavioral (CBT) therapy is a modified form of CBT designed to be applicable with patients across the range of anxiety and related emotional disorders. Based on emerging genetic, neurologic, developmental, cognitive, and behavioral science, transdiagnostic CBT may alleviate barriers to dissemination and accessibility by providing a single treatment approach across diagnoses. Data from clinical trials and metaanalyses suggest treatment efficacy that is comparable with traditional CBT approaches, with possibly superior efficacy among patients with multiple comorbid anxiety and emotional diagnoses. Limitations in the evidence base and remaining areas for future research are discussed.
Movement towards transdiagnostic psychotherapeutic practices for the affective disorders. [2018]Evidence-based cognitive behavioural therapy (CBT) practices were first developed in the 1960s. Over the decades, refinements and alternative symptom foci resulted in the development of several CBT protocols/manuals for each of the many disorders, especially in the affective disorders. Although shown to be effective in highly trained providers, the proliferation of CBT protocols also has shown to demonstrate challenges in dissemination and implementation efforts due to the sheer number of CBT protocols and their related training requirements (eg, 6 months per protocol) and their related cost (eg, over US$2000 each; lost days/hours at work). To address these concerns, newer transdiagnostic CBT protocols have been developed to reduce the number of disorder-specific CBT protocols needed to treat patients with affective disorders. Transdiagnostic treatments are based on the notion that various disorder-specific CBT protocols contain important but overlapping treatment components that can be distilled into a single treatment and therefore address the symptoms and comorbidities across all of the disorders at once. 3 examples of transdiagnostic treatments include group CBT of anxiety, unified protocol for transdiagnostic treatment for emotional disorders and transdiagnostic behaviour therapy. Each transdiagnostic protocol is designed for a different set of disorders, contains a varied amount of CBT treatment components and is tested in different types of samples. However, together, these 3 transdiagnostic psychotherapies represent the future of CBT practice.
Brief cognitive behavior therapy in patients with social anxiety disorder: a preliminary investigation. [2020]Cognitive behavior therapy (CBT) is the treatment of choice in anxiety disorders. However, there is little evidence for the effectiveness brief CBT in social anxiety.
Manualized Cognitive-Behavioral Treatment of Social Anxiety Disorder: A Case Study. [2021]Social anxiety disorder (SAD), also known as social phobia, is one of the most common anxiety disorders and has been shown to be effectively treated using cognitive-behavioral therapy (CBT). Recently, a manualized CBT treatment for SAD has been developed (Hope, Heimberg, & Turk, 2006), with research demonstrating superior treatment outcomes with CBT relative to alternatives (e.g., psychotropic medication). The current case study of Henry, a 26-year old Caucasian male with SAD, implemented this manualized CBT for SAD. Treatment consisted of 15 individual sessions, with follow-ups occurring 2 and 8 months post-treatment. Henry showed marked reductions in SAD symptoms throughout the course of treatment, resulting in complete remission of SAD at the end of formal treatment. His SAD continued to be in remission at the 2-and 8-month follow-up sessions. This case study demonstrates the usefulness of a manualized, individual CBT treatment for SAD.