Patients facing chronic medical conditions are at increased risk for depression and anxiety. The associations between depression and anxiety and poor patient outcomes are clear and dramatic. Unfortunately, despite this prevalence and impact, few medically ill patients receive mental health treatment and there continues to be a dearth of information related to the use of non-medication mental health treatments such as CBT in primary care settings. To set the stage for future CBT programs within VA, additional research is needed to document the real-world effectiveness of this treatment approach. The assembled research team seeks to examine the effectiveness of CBT within VA primary care settings using existing VA providers as study clinicians. We hypothesize that medically ill veterans receiving CBT from primary care mental health clinicians will show greater improvement in depressive / anxious symptoms and physical disease outcomes relative to a usual care (UC) control arm at post-treatment and 8- and 12-month follow-up. Secondary aims will assess patient treatment adherence and therapist CBT competence. Exploratory aims will examine the cost effectiveness of the intervention, assess stakeholder perceptions, and longer- term intervention application post-study. The present 4-year investigation will focus on the effectiveness of CBT for complex and chronically ill veterans using a randomized effectiveness study design. Medically ill veterans, defined as patients with chronic heart or lung disease, with comorbid symptoms of depression and/or anxiety will be recruited. Provision of CBT will occur through the VISN 16 mental health in primary care initiative at 2 hospitals (Houston and Oklahoma City). Eligible patients will be randomized to either the CBT intervention or to UC. CBT providers will include nurses, social workers, counselors and psychologists who are currently providing mental health care as part of the VA's Mental Health in Primary Care Initiative. The CBT treatment will consist of a manualized therapy developed for our prior HSR&D IIR study (Kunik) and subsequently modified using data obtained from our SC MIRECC funded trial (Cully). CBT treatment will involve weekly sessions over a period of 6 weeks using a modular approach to care via in- person and telephone sessions. Four bi-weekly follow-up telephone booster sessions will be used to maintain and solidify changes. In total, CBT will involve 16 weeks of care. Patients assigned to UC will be provided with educational materials, routine assessments, and will be encouraged to seek additional care through their existing VA providers.
This study will target multifaceted outcomes including patient physical and emotional health as well as the potential for a structured cognitive-behavioral therapy intervention to be adopted and implemented within VA. The proposed evidence-based CBT, developed for the medically ill, will be administered by VA mental health practitioners in the primary care setting. Outcomes will examine patient physical/functional abilities and depression/anxiety as well as patient and therapist factors associated with CBT adoption and implementation. This data will help providers, managers, and policy makers to understand the potential challenges and benefits to implementation of evidence-based CBT practices in VA for medically ill veterans.
