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.
Treatment Training and Fidelity All therapy will be led by one of the project therapists
in a rotating fashion. Training workshops will be provided for the two treatment
protocols. Established trainers and experts will be recruited to provide each of the
trainings. Trainings will be supported by weekly supervision on the two protocols led by
the matching trainer throughout the duration of the treatment phase, with additional
supervision sessions provided as needed.
Consistent with other well-designed treatment outcome studies, all treatment sessions
will be audio recorded with 20% of sessions randomly selected for review for treatment
integrity and fidelity. These integrity and fidelity reviews will focus on evaluating the
match between the treatment manuals and the material covered in session. To evaluate
adherence, treatment-specific rating forms will be used to determine if the therapist
appropriately covered the content of each session. Experts will be recruited to rate the
recordings independently, with feedback provided to the therapists throughout the
duration of the study to maintain treatment delivery with high fidelity.
Assessment of Quality of Life, Psychological Well-Being, Social Reintegration,
Psychiatric Symptomatology, and Treatment Satisfaction Follow-up assessments will be
conducted for all participants during VA visits or via home based telehealth by trained
interviewers blind to treatment conditions. The battery of self-report questionnaires and
a diagnostic interview will be completed pre-, mid-, and post-treatment and at the
6-month follow-up to track participant progress through the treatment and maintenance
phases.
To reduce the likelihood of missing data, primary assessments will be scheduled
separately from treatment sessions. The biweekly measures will include disorder-specific
measures that will be administered at the beginning of therapy sessions and used to
inform the clinical delivery of the psychotherapies (measurement-based care) and assist
in the intent-to-treatment analyses and analysis of trajectories.
All assessments will be completed by the Project Research Recruiter and Assessor.
Additional training will be required prior to administration of the diagnostic interview.
The assessor will be blinded to treatment condition and supervised by the PI. Assessments
will be recorded to investigate inter-rater reliability of diagnoses, with 20% of
recordings being re-assessed by a trained assessor after the participant has completed
all study procedures, with feedback provided to the assessor throughout the study to
maintain high reliability.