About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be Veterans and registered at Ralph H. Johnson Veterans Affairs Health Care System
Participants must be clearly competent to provide informed consent for research participation
Participants must meet DSM-5 criteria for social anxiety disorder
Participants must have clinically significant symptoms of comorbid posttraumatic stress
Disqualifiers
recent history (< 2 months) of psychiatric hospitalization or a suicide attempt as documented in their medical record,
acute, severe illness or medical condition that likely will interfere with study procedures as documented in their medical record
recent start of new psychiatric medication(s) (< 4 weeks),
primary diagnosis of a condition associated with psychotic symptoms, personality disorder, substance use disorder, or bipolar disorder.
Trial design
Parallel
Treatments tested in this trial
Transdiagnostic Behavior Therapy
BehavioralTBT 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.
Cognitive Behavioral Therapy for Social Anxiety Disorder
BehavioralTo 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.
Treatment groups
Trial outcomes
Primary outcomes
MASA functional impairment
The MASA is a 38-item self-report measure that was designed to assess trait symptom dimensions consistent with the hybrid model of social anxiety. The MASA contains six subscales that assess behavioral avoidance, physiological arousal and avoidance, thought avoidance, anhedonia, functional impairment, and coping with substances. The six subscales have shown to differentiate symptoms across anxiety disorders and depression and their comorbidities and to be sensitive to improvements evidenced in therapy.
PTSD Checklist for DSM-5 (PCL-5)
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are scored on a 5-point scale, range from 0 (not at all) to 4 (extremely). The total scale score ranges from 0 to 80 with higher scores associated with more severe symptomatology. Previous versions of the PCL have been shown to have excellent internal consistency and excellent test-retest reliability in Veterans. In addition, the PCL-5 has been incorporated into standard assessment for PTSD at the VA. The PCL5 will be used to assess symptoms of PTSD.
Illness Intrusiveness Rating Scale (IIRS)
The IIRS is a 13-item questionnaire that assesses the extent to which a disease interferes with important domains of life, including health, diet, work, and several others. The IIRS has been shown to have strong psychometric properties in the previous literature in participants with physical and emotional health concerns, and has been used in previous TBT studies.
Sponsors and contacts
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