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Principal Investigator: Victoria Diane Powell
Organization: VETERANS HEALTH ADMINISTRATION
Fiscal Year: 2024
Funding agency: Veterans Affairs
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.
Terms: <Address><Analgesic Agents><Analgesic Drugs><Analgesic Preparation><Analgesics><Anesthestic Drugs><Anesthetic Agents><Anesthetic Drugs><Anesthetics><Anodynes><Antinociceptive Agents><Antinociceptive Drugs><Behavioral><Cardiac Diseases><Cardiac Disorders><Chronic Disease><Chronic Illness><Chronic depressive disorder><Chronic low back pain><Clinical Sciences><Clinical Treatment><Clinical Trials><Cognitive><Complex><Control Groups><Data><Development><Development and Research><Diabetes Mellitus><Distress><Dose><Educational Materials><Effectiveness><Emotional Depression><Environment><Feedback><Feeling><Feeling suicidal><General Population><General Public><Goals><Health Care Systems><Healthcare><Healthcare Systems><Heart Diseases><Hour><Infusion><Infusion procedures><Integrative Therapy><Integrative Treatment><Integrative intervention><International><Intervention><Intervention Strategies><Interview><Investigators><Ketamine><Maintenance><Manuscripts><Medical><Mental Depression><Mental Health><Mental Hygiene><Mentorship><Modeling><Moods><NIH><National Institutes of Health><Opiates><Opioid><PTSD><Pain><Pain intensity><Pain interference><Painful><Palliative Care><Palliative Therapy><Palliative Treatment><Participant><Patients><Pattern><Perception><Persons><Phase><Phase I Study><Physicians><Pilot Projects><Population><Post-Traumatic Neuroses><Post-Traumatic Stress Disorders><Posttraumatic Neuroses><Prevalence><Process><Property><Protocol><Protocols documentation><Psychological Health><Psychotherapy><Qualitative Methods><R & D><R&D><Randomized><Randomized, Controlled Trials><Reporting><Research><Research Personnel><Research Priority><Researchers><Sample Size><Scientist><Series><Structure><Suicidal thoughts><Target Populations><Testing><Time><Training><Unemployment><United States><United States National Institutes of Health><Veterans><Work><alternative treatment><anti-depressant agent><anti-depressant drugs><anti-depressants><anti-depressive agents><arm><career><chronic depression><chronic disorder><chronic pain><chronic pain control><chronic pain intervention><chronic pain management><chronic pain therapy><chronic pain treatment><clinical trial analysis><co-morbid><co-morbid depression><co-morbid with depression><co-morbidity><co-morbidity with depression><comfort care><comorbid depression><comorbid with depression><comorbidity><comorbidity with depression><depression><depression co-morbidity><depression comorbidity><depression symptom><depressive><depressive symptoms><design><designing><develop therapy><developmental><diabetes><disability><efficacy testing><experience><feelings><flexibility><flexible><functional improvement><health care><heart disorder><improve function><improved><improved functional outcomes><improved outcome><infusions><innovate><innovation><innovative><intervention delivery><intervention design><intervention development><intervention effect><interventional strategy><jobless><joblessness><multidisciplinary><open label><open label study><out of work><pain killer><pain medication><pain reduction><pain reliever><painkiller><pharmacologic><phase 1 study><phase 2 study><phase II study><pilot study><pilot test><post-trauma stress disorder><posttrauma stress disorder><primary outcome><psychologic><psychological><psychosocial><qualitative reasoning><randomisation><randomization><randomized control trial><randomly assigned><reduce pain><reduce suicidality><reduce suicide><reducing suicidality><reducing suicide><research and development><skills><suicidal ideation><suicidal thinking><suicide ideation><therapy design><therapy development><thoughts about suicide><traumatic neurosis><treat chronic pain><treatment design><treatment development><treatment effect><treatment-refractory depression><treatment-resistant depression><trial regimen><trial treatment><unemployed>