Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders

Objective To evaluate the transdiagnostic CBT in a randomized clinical trial (RCT) of VAMC
patients with depressive/anxiety disorders by investigating its preliminary efficacy in
reducing symptomatology, comorbidity, and improving quality of life compared to behavioral
activation therapy (BAT) (psychotherapy control condition). Patient satisfaction and
predictors of feasibility (attendance and dropout) also will be assessed.

Recruitment Strategy VAMC patients will be recruited through the Primary Care - Mental Health
Integration program and CBT Clinic at the Ralph H. Johnson (RHJ) VAMC. Within these programs,
all VAMC patients reporting symptoms of depression and anxiety meet with a mental health
staff member to complete a diagnostic interview and self-report measures as part of their
standard clinical practices. If VAMC patients endorse symptoms consistent with a
depressive/anxiety disorder, the patient's interest in participating in research will be
assessed and, if agreeable to research, patients will be put in contact with research staff
(same day meeting and/or follow-up phone to schedule research assessment). 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 96 VAMC patients; >
72 completers), including a semi-structured clinical interview and self-report questionnaires
focused on the psychiatric symptoms and quality of life. Participants who meet diagnostic
criteria for the targeted disorders 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. To
balance diagnoses across the two conditions, a stratified random assignment based on
principal diagnosis will be used for the most common principal diagnoses (MDD, PTSD, and PD).

Procedures Eligible VAMC patients will be randomized into one of two treatment conditions:
transdiagnostic CBT or BAT. Both treatment conditions will include 12-16 weekly 50-minute
individual psychotherapy sessions. The total number of sessions will vary slightly depending
on participant needs and progress during therapy, as is common in most CBT approaches to
psychotherapy (and will serve as a covariate in the outcome analyses). 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 = 59 per arm) using a permuted block randomization procedure. Randomization will be
stratified by principal diagnostic group 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 treatment groups by the
Project Research Assistant using a computer generated randomization scheme. Once a
participant is randomized and attends the first session, they will be included in the
intent-to-treat analysis. Randomization will occur at the participant level.

Transdiagnostic CBT Treatment Condition As noted above in the Preliminary Studies section, a
transdiagnostic CBT protocol was developed and revised through two demonstration studies and
one focus group. The resulting protocol involves several primary components, including
psychoeducation on the symptoms of depression and anxiety (session 1), assessment of
motivation and setup of treatment plans (session 2), exposure therapy (sessions 3-15), and
relapse prevention (final session). In addition to these primary components, optional modules
are included to supplement exposure therapy later in treatment to address secondary symptoms
(e.g., anger, sleep, hypervigilance, drinking to cope). The goal of these modules is to allow
providers to tailor treatment to specific symptoms that may be present in any single or set
of diagnoses that may be reducing the effects from the primary exposure approach. Session
will be weekly for 45-60 minutes with homework assignments to be completed between sessions.

BAT Control Condition To provide an evidence-based comparison for the transdiagnostic CBT
condition, a second group of participants will receive manualized BAT. BAT is based on early
behavioral models that suggest that decreases in positively reinforcing healthy behaviors are
associated with the development of negative affect. In general, BAT involves teaching
patients to monitor their mood and daily activities with the goal of increasing pleasant,
reinforcing activities and reducing unpleasant events. BA is a brief treatment, can be
administered in either individual or group formats, and has demonstrated reliable
effectiveness across a wide range of university, community, civilian and Veteran clinical
samples with depression. BAT also has been shown to be effective in the treatment of PTSD and
other related depressive/anxiety disorders in Veterans. In the present study, the BAT
condition will be manualized, following an existing protocol in the literature. BAT will be
structurally equivalent to the transdiagnostic CBT with the same session length (45-60
minutes), frequency of sessions (weekly), duration of treatment (12-16 sessions), and amount
of homework.

Inclusion Criteria:

Inclusion criteria involve:

- participants must be clearly competent to provide informed consent for research
participation;

- participants must meet DSM diagnostic criteria for a principal diagnosis of a
depressive/anxiety disorder (Panic Disorder, PTSD, Social Anxiety Disorder,
Obsessive-Compulsive Disorder (OCD), Generalized Anxiety Disorder (GAD), specific
phobia, major depressive disorder, or persistent depressive disorder); and

- participants must be 18 - 80 years old.

Exclusion Criteria:

Exclusion criteria involve:

- recent history (< 2 months) of psychiatric hospitalization or a suicide attempt as
documented in their medical record,

- current diagnosis of substance dependence or abuse on the structured clinical
interview,

- acute, severe illness or medical condition that likely will require hospitalization
and/or otherwise interfere with study procedures as documented in their medical record
(e.g., active chemotherapy/radiation treatment for cancer, kidney dialysis, oxygen
therapy for chronic obstructive pulmonary disease),

- recent start of new psychiatric medication (< 4 weeks),

- diagnosis of traumatic brain injury (TBI) in their medical record and/or endorsement
of screener questionnaire regarding the symptoms of TBI modified from the
Post-Deployment Health Assessment employed by the Department of Defense, or

- diagnosis of schizophrenia, psychotic symptoms, personality disorder, and/or bipolar
disorder. VAMC patients excluded due to these factors will be reconsidered for
participation once the condition related to their exclusion is resolved or stabilized.
Together, these inclusion/exclusion criteria should allow the vast majority of
interested VAMC patients with depressive/anxiety disorders to be eligible to
participate. Ineligible VAMC patients will be referred for non-study-related
treatments within mental health at the RHJ VAMC.