Objective To examine efficacy of Transdiagnostic Behavior Therapy (TBT) on improving
psychiatric symptomatology and related impairments in Veterans with major depressive
disorder (MDD), posttraumatic stress disorder (PTSD), and panic disorder and agoraphobia
(PD/AG) compared to disorder-specific treatments (DSTs) via a non-inferiority design.
Patient satisfaction and predictors of feasibility (attendance and discontinuation) also
will be assessed.
Recruitment Strategy and Feasibility of Recruitment Veterans will be recruited through
the Primary Care Mental Health Integration, General Outpatient Mental Health, and CBT
Clinic programs at the Ralph H. Johnson VAMC and all affiliated VA community-based
outpatient clinics. IRB-approved study flyers will be distributed through each
clinic/setting. Within these programs, all Veterans reporting symptoms of depression and
anxiety meet with a mental health staff member to complete a clinical interview and
self-report measures. If Veterans endorse symptoms consistent with a depressive/anxiety
disorder, interest in participating in research will be assessed and, if agreeable, the
Veteran will be referred to project staff. A research assessment will be completed with
the project staff to first complete consent documentation and then assess
inclusion/exclusion criteria (with a targeted sample of 306 VAMC patients), including a
semi-structured clinical interview and self-report questionnaires focused on psychiatric
symptomatology and related impairments (described later). Participants who meet
inclusion/exclusion criteria will be randomized into a study condition and will be
assigned to a project therapist. Because most VA Medical Center (VAMC) patients who meet
study criteria likely will present with multiple depressive/anxiety disorders, principal
diagnosis, or the most impairing of the diagnosable disorders, will be used to inform
randomization. Principal diagnosis will be determined via diagnostic severity scores in
the Anxiety Disorders Interview Schedule-5 (ADIS-5). To balance diagnoses across the two
conditions, a stratified random assignment based on principal diagnosis will be used
(MDD, PTSD, and PD/AG).
Procedures Eligible VAMC patients will be randomized into one of two treatment
conditions: TBT or DSTs. Both treatment conditions will include 12 weekly 45- to
60-minute treatment 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 (n = 108 per arm) using a permuted block randomization procedure.
Randomization will be stratified by diagnostic group (PTSD, PD/AG, MDD) and block size
will be varied to minimize the likelihood of unmasking. After determining eligibility and
completing consent and baseline assessment materials, enrolled participants will be
assigned to their treatment condition by the Research Project Therapist/Coordinator using
a computer-generated randomization scheme.
Transdiagnostic Behavior Therapy TBT was developed as a streamlined protocol to address
transdiagnostic avoidance via the use of four different types of exposure techniques
(situational/in-vivo, physical/interoceptive, thought/imaginal, and positive emotional).
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. Per protocol, the first six sessions of TBT are designed to educate
on, prepare for, and practice the four different types of exposure techniques. The next
five sessions are focused on practicing and refining exposure practices as participants
work through their lists of avoided situations/sensation/thoughts. The final session
reviews treatment progress and relapse prevention strategies.
DSTs Control Condition Matching and Assignment To provide an evidence-based comparison
for the TBT condition, DSTs will be used that are matched to the participant's most
severe diagnosis, based upon the average of the ADIS interference and distress scores. If
the scores are equivalent for two or more diagnoses, participants will be asked to list
which diagnosis/symptoms that they find most impairing. DSTs will be included for each of
the three targeted diagnoses, including PTSD (Cognitive Processing Therapy for PTSD),
PD/AG (Cognitive Behavioral Therapy for PD/AG), and MDD (Cognitive Behavioral Therapy for
MDD). Each of these DSTs have published manuals for administration and have received
extensive support in the literature (Barlow, 2014). All three DSTs have been shown to
improve comorbid symptomatology and therefore may be a more accurate comparison to TBT as
compared to other available DSTs that may have less effect on comorbidity (e.g., applied
relaxation for PD/AG).
Assessment of Psychiatric Symptomatology, and Treatment Satisfaction 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 participants' progression through
treatment and maintenance. To reduce the likelihood of missing data, all assessments will
be scheduled separately from normal treatment sessions. Assessments of disorder-specific
symptomatology, as well general symptoms of the depressive/anxiety disorders and related
impairments, were chosen due to the transdiagnostic focus of the proposed study.
