Transdiagnostic Psychotherapy for Veterans With Mood and Anxiety Disorders
Condition: Major Depressive Disorder; Persistent Depressive Disorder; Posttraumatic Stress Disorder; Panic Disorder; Social Phobia; Specific Phobia; Generalized Anxiety Disorder; Obsessive Compulsive Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic; Phobic Disorders; Panic Disorder; Phobia, Social
Study type: Interventional

Summary: 
      Cognitive behavioral therapy (CBT) is a brief, efficient, and effective psychotherapy for
      individuals with depressive and anxiety disorders. However, CBT is largely underutilized
      within Veteran Affairs Medical Centers (VAMCs) due to the cost and burden of trainings
      necessary to deliver the large number of CBT protocols. Transdiagnostic CBT, in contrast, is
      specifically designed to address numerous distinct disorders within a single protocol. This
      transdiagnostic approach has the potential to dramatically improve the accessibility of CBT
      within VAMCs and therefore improve clinical outcomes of Veterans. The proposed research seeks
      to evaluate the efficacy of a transdiagnostic CBT by assessing clinical outcomes and quality
      of life in VAMC patients with depressive and anxiety disorders throughout the course of
      treatment and in comparison to an existing evidence-based psychotherapy, behavioral
      activation treatment.
    

Detailed description: 
      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.
    

Intervention name(s): Transdiagnostic Behavior Therapy; Behavioral Activation Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A new transdiagnostic CBT protocol for the depressive/anxiety disorders 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.; To provide an evidence-based comparison for the transdiagnostic CBT condition, a second group of participants will receive manualized BAT. 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. 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: behavior therapy; Randomized Controlled Trials; Depressive Disorder; Anxiety Disorders; comorbidity