Ketamine-assisted integrative treatment for Veterans with chronic low back pain and comorbid depression
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Background: Chronic low back pain (CLBP) and depression are the two most common causes of disability in America. When they occur together, patients have more functional limitations, higher healthcare spending, and treatment is more likely to fail. Ideal treatments would address pain interference with function and improve mood in patients with both CLBP and depression. Ketamine is an anesthetic with rapid analgesic and antidepressant properties. Unfortunately, its effect for both pain and depression fades over time, necessitating maintenance dosing. Thus, non-invasive treatments that enhance and sustain its benefits are needed. Significance/Impact: This application proposes a career training and research plan to develop a narrative intervention designed to be administered shortly after a series of ketamine infusions, conduct initial pilot testing, and complete a small feasibility randomized controlled trial (RCT). A narrative intervention, [designed to be delivered in the days after receiving ketamine,] could be particularly helpful [in reducing pain interference] for patients in whom formal psychotherapy may not be acceptable. Narrative interventions reduce distress by helping people organize difficult experiences (such as chronic illness) into a cohesive story; this process results in the perception that the experience is more manageable. Commonly used in palliative care, narrative interventions have demonstrated effectiveness for both pain and depression and are highly acceptable. This research agenda is well-aligned with the Clinical Science Research and Development priority research focus on both chronic pain treatment alternatives to opioids and mental health conditions highly prevalent in Veterans (e.g., depression). Short-term, results will lead to a Merit Review proposal to test the intervention in an adequately powered RCT. Long-term, Dr. Powell will gain skills broadly applicable to (a) complex intervention development (e.g., those combining pharmacologic and behavioral components) and (b) designing and conducting high quality clinical trials of these treatments in Veterans with chronic illnesses. Dr. Powell is a VHA palliative care physician and research scientist whose long-term goal is to become an independent investigator focused on improving outcomes for Veterans with chronic pain and psychosocial distress. Innovation: This study will be the first to test a narrative intervention as a strategy for enhancing ketamine’s benefits, with an emphasis on pain interference with function. It focuses on Veterans with both CLBP and depression – a population that stands to benefit from ketamine’s analgesic and antidepressant actions. Specific Aims: Study Phase I aims to develop and refine a targeted narrative intervention for Veterans with CLBP and co-occurring depression using a modified ADAPT-ITT approach. The initial aim involves the identification of relevant components of existing narrative interventions followed by semi-structured interviews with Veterans and clinicians to obtain detailed feedback. Next, an open-label pilot involving a series of ketamine infusions followed by the narrative intervention will assess initial feasibility and barriers, allowing protocol refinement. Study Phase II will consist of a 2-arm pilot RCT with a control group who does not receive the narrative intervention [(n=22 participants/group)]. Deliverables from Aims: Two manuscripts per aim are anticipated. Importantly, this work will facilitate sample size calculations to inform an adequately powered RCT to be submitted as a Merit proposal (Year 4). This RCT will investigate the impact of the intervention upon the primary outcome - pain interference with function. Dr. Powell will work with her mentorship team to disseminate findings and strategically implement this work to maximize benefits for Veterans.
