This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression.
Chronic low back pain (CLBP) and depression are top causes of disability in the United States. Veterans are more likely to have both; prevalence is increasing. When CLBP and depression occur together, patients report more functional limitations, unemployment, and higher healthcare spending, and treatment is less successful. Novel approaches simultaneously addressing pain interference and depression symptoms are needed. This study will involve initial pilot feasibility testing of an intervention designed to help participants with chronic low back pain and depression both reduce pain interference and improve mood. This study will occur in two phases. The initial phase is a open-label single-arm pilot of the combined intervention (ketamine infusions followed by the brief behavioral intervention) in a small sample of Veterans (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The second phase consists of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
44
Participants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg.
Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression and will be provided to participants in arms 2 and 3 (pilot RCT).
Participants in Arm 1 (open label pilot) will receive the brief narrative intervention after four ketamine infusions. Participants in Arm 2 (those randomized after ketamine infusions are complete to the active arm of the pilot RCT) will receive the brief narrative intervention.
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
RECRUITINGPain Interference (PROMIS Short Form v1.1 Pain Interference 6b)
Pain interference, defined as the extent to which pain impedes enjoyment of and participation in life activities (including cognitive, social, recreational, and self-care activities), will be the primary outcome. Raw scores (range 6 - 30, higher scores indicating more interference) are normed to mean of general population (T-score 50; SD 10); higher T-scores indicate higher pain interference. Minimum clinically important change is 3.0 - 3.5 point reduction in the T-score.
Time frame: Visit 7 (8-10 days post randomization)
Pain intensity (Numeric Rating Scale)
Pain intensity will be measured using the NRS, a single-item measure where participants rate their pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). In chronic pain, a reduction of 2 points or 30% is considered a meaningful improvement.
Time frame: Visit 7 (8-10 days post randomization)
Depression (Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) )
The Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) is a 16-item rating scale assessing self-report of depressive symptoms. Scores range from 0 - 27, with higher scores indicating more severe depressive symptoms. Reductions of approximately 30% are considered clinically meaningful improvements in depressive symptoms.
Time frame: Visit 7 (8-10 days post randomization)
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