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.
Do I have to stop taking my current medications for the trial?The protocol does not specify if you need to stop taking your current medications. However, if you recently started new psychiatric medications within the last 4 weeks, you may not be eligible to participate.
Is Cognitive Behavioral Therapy a promising treatment for Social Anxiety Disorder?Yes, Cognitive Behavioral Therapy (CBT) is a promising treatment for Social Anxiety Disorder. Studies show that both disorder-specific and transdiagnostic CBT can significantly reduce symptoms of social anxiety and related issues like depression and panic disorder. These improvements are maintained over time, making CBT an effective option for treating social anxiety.135811
What data supports the idea that Cognitive Behavioral Therapy for Social Anxiety Disorder is an effective treatment?The available research shows that Cognitive Behavioral Therapy (CBT) is effective for treating Social Anxiety Disorder (SAD). One study found that both individual and group CBT significantly reduced social anxiety and depression symptoms compared to a waitlist group. Another study demonstrated that internet-delivered CBT led to large reductions in SAD symptoms and moderate-to-large reductions in symptoms of related conditions like depression and generalized anxiety disorder. These improvements were maintained or even enhanced over a 24-month follow-up period. Compared to other treatments like systemic therapy and psychodynamic therapy, CBT is often considered the 'gold standard' for SAD, indicating its strong effectiveness.4591011
What safety data exists for CBT for Social Anxiety Disorder?The safety data for Cognitive Behavioral Therapy (CBT) for Social Anxiety Disorder (SAD) and related anxiety disorders is generally positive. Studies have shown that both disorder-specific and transdiagnostic CBT approaches are effective in reducing symptoms of SAD and comorbid conditions like depression, generalized anxiety disorder, and panic disorder. These treatments have been tested in various formats, including internet-delivered and brief individual sessions, with significant reductions in anxiety and depression symptoms reported. The evidence suggests that CBT, including its transdiagnostic forms, is a safe and effective treatment option for SAD and other anxiety disorders.25678
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.Treatment Details
The 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.
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
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.