A Randomized Clinical Trial Comparing Transdiagnostic Behavior Therapy to Disorder-Specific Psychotherapy in the Recovery of Veterans With Social Anxiety Disorder and Comorbid PTSD Symptomatology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 264
- Locations
- 1
- Primary Endpoint
- MASA functional impairment
Study Overview
Brief Summary
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.
Detailed Description
Objective The objective of the present study is to examine efficacy of TBT in improving quality of life, psychological well-being, and social reintegration of Veterans with SAD and comorbid PTSD symptomatology compared to a DST for SAD using an RCT design. Patient satisfaction and predictors of feasibility (attendance and discontinuation) also will be assessed.
Recruitment Strategy Veterans will be recruited through the Primary Care Mental Health Integration, General Outpatient Mental Health, and Mental Health Specialty Clinic (e.g., PTSD Clinical Team) programs within the Charleston VAHCS and associated CBOCs. Within the targeted clinics, all Veterans reporting symptoms of social anxiety meet with a mental health staff member to complete a clinical interview and self-report measures. If Veterans endorse symptoms consistent with SAD and PTSD symptomatology, interest in participating in research will be assessed and, if agreeable, the Veteran will be referred to project staff.
Intake Procedures A study-specific intake appointment will be completed with the project staff to complete consent documentation as well as assess inclusion and exclusion criteria, including a semi-structured clinical interview and self-report questionnaires. Screening and consent will take place at the participant's residence via telehealth by research staff or in person at the VAHCS, based upon the preference of the participant.
Treatment Procedures Participants who meet inclusion and exclusion criteria will be randomized into a study condition and assigned to a project therapist. Eligible VAHCS patients will be randomized into one of two treatment conditions: TBT or DST (CBT for SAD). Both treatment conditions will include 12 weekly 60-minute individual psychotherapy sessions. The general format of sessions will involve: 1) brief check-in; 2) review of materials from previous sessions; 3) review of homework assignments; 4) overview of new materials and in-session exercises; and 5) assignment of homework for next session. Attendance and homework completion will be recorded.
Randomization Procedures Participants will be randomly assigned (1:1) to one of the two study arms using a permuted block randomization procedure. After determining eligibility and completing consent and baseline assessment materials, enrolled participants will be assigned to treatment conditions using a computer-generated randomization scheme and communicated to the assigned study therapist. Once randomized, participants will be included in the intent-to-treat analysis. Randomization will occur at the participant level.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Transdiagnostic Behavior Therapy
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.
Intervention: Transdiagnostic Behavior Therapy (Behavioral)
Cognitive Behavioral Therapy for Social Anxiety Disorder
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.
Intervention: Cognitive Behavioral Therapy for Social Anxiety Disorder (Behavioral)
Outcomes
Primary Outcomes
MASA functional impairment
Time Frame: change from baseline to week 6 to week 12 to 6-month followup
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.
Illness Intrusiveness Rating Scale (IIRS)
Time Frame: change from baseline to week 6 to week 12 to 6-month followup
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.
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: change from baseline to week 6 to week 12 to 6-month followup
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.
Secondary Outcomes
No secondary outcomes reported