Objective To examine efficacy of G-TBT on improving quality of life, psychological
well-being, and social reintegration of Veterans with PTSD, Major Depressive Disorder,
and related conditions compared to G-DSTs using a non-inferiority design. Patient
satisfaction, access, 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 CBT Clinic programs at the Charleston
VAMC. 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 study-specific intake appointment will be completed
with the project staff to assess inclusion/exclusion criteria (with a targeted sample of
326 VAMC patients), including a semi-structured clinical interview and self-report
questionnaires focused on quality of life, social integration, and psychiatric symptoms
(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 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 select patients for participation and inform randomization. Principal
diagnosis will be determined via diagnostic severity scores in the Anxiety Disorders
Interview Schedule-5. To balance diagnoses across the two conditions, a stratified random
assignment based on principal diagnosis will be used (Major Depressive Disorder and
PTSD).
Procedures Eligible VAMC patients will be randomized into one of two treatment
conditions: G-TBT or G-DSTs. Both treatment conditions will include 12 weekly 90-minute
group 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.
Treatment groups (G-TBT, Group CBT-Depression, Group Cognitive Processing Therapy for
PTSD) will require at least 6 participants and maximum of 12 participants to begin. Upon
randomization, participants will be notified of the group assignment and expected wait
period for the group to begin. Wait periods (in days) will be recorded as an indicator of
access to treatment across groups.
Randomization Procedures Participants will be randomly assigned (1:1) to one of the two
study arms (n = 104 per arm) using a permuted block randomization procedure.
Randomization will be stratified by principal diagnostic group (or most impairing
disorder between Major Depressive Disorder and PTSD if both disorders are present, based
upon disorder-specific interference and distress severity scores) and block size will be
varied to minimize the likelihood of unmasking. If both disorders evidence identical
severity scores (highly unlikely), participants will be asked which of the two disorders
is more impairing/significant for randomization purposes. After determining eligibility
and completing consent and baseline assessment materials, enrolled participants will be
assigned to treatment conditions by the Research Coordinator/Therapist using a
computer-generated randomization scheme. Once a participant is randomized, they will be
included in the intent-to-treat analysis. Randomization will occur at the participant
level.
Group 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/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. 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.
G-DSTs Control Condition Matching and Assignment To provide an evidence-based comparison
for the G-TBT condition, G-DSTs will be used that are matched to the participant's
principal diagnosis. G-DSTs will include groups for the most common principal diagnoses
that have VA-approved protocols and training programs, including PTSD (Cognitive
Processing Therapy for PTSD) and Major Depressive Disorder (CBT-Depression). Each of
these G-DSTs have published manuals for administration and have received extensive
support in the literature. Participants randomized to a G-DST group will be matched to
disorders, principal diagnosis, or the most impairing of the diagnosable disorders, will
be used to select patients for participation and inform randomization. Principal
diagnosis will be determined via diagnostic severity scores in the Anxiety Disorders
Interview Schedule-5. To balance diagnoses across the two conditions, a stratified random
assignment based on principal diagnosis will be used (Major Depressive Disorder and
PTSD).

Procedures Eligible VAMC patients will be randomized into one of two treatment
conditions: G-TBT or G-DSTs. Both treatment conditions will include 12 weekly 90-minute
group 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.

Treatment groups (G-TBT, Group CBT-Depression, Group Cognitive Processing Therapy for
PTSD) will require at least 6 participants and maximum of 12 participants to begin. Upon
randomization, participants will be notified of the group assignment and expected wait
period for the group to begin. Wait periods (in days) will be recorded as an indicator of
access to treatment across groups.

Randomization Procedures Participants will be randomly assigned (1:1) to one of the two
study arms (n = 104 per arm) using a permuted block randomization procedure.
Randomization will be stratified by principal diagnostic group (or most impairing
disorder between Major Depressive Disorder and PTSD if both disorders are present, based
upon disorder-specific interference and distress severity scores) and block size will be
varied to minimize the likelihood of unmasking. If both disorders evidence identical
severity scores (highly unlikely), participants will be asked which of the two disorders
is more impairing/significant for randomization purposes. After determining eligibility
and completing consent and baseline assessment materials, enrolled participants will be
assigned to treatment conditions by the Research Coordinator/Therapist using a
computer-generated randomization scheme. Once a participant is randomized, they will be
included in the intent-to-treat analysis. Randomization will occur at the participant
level.

Group 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/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. 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.

G-DSTs Control Condition Matching and Assignment To provide an evidence-based comparison
for the G-TBT condition, G-DSTs will be used that are matched to the participant's
principal diagnosis. G-DSTs will include groups for the most common principal diagnoses
that have VA-approved protocols and training programs, including PTSD (Cognitive
Processing Therapy for PTSD) and Major Depressive Disorder (CBT-Depression). Each of
these G-DSTs have published manuals for administration and have received extensive
support in the literature. Participants randomized to a G-DST group will be matched to
the G-DST based on the principal diagnosis determined via the diagnostic interview.
