Pilot sequential study (n=44 planned; initial n=5 open-label pilot) assessing feasibility, acceptability, and safety of four twice-weekly IV ketamine infusions (0.5 mg/kg) followed by a brief narrative intervention versus minimally enhanced usual care in Veterans with chronic low back pain and depression.
This pilot evaluates feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioural narrative intervention to reduce pain interference and improve mood in Veterans with chronic low back pain and comorbid depression.
The study occurs sequentially: an initial open-label single-arm pilot (n=5) to refine procedures and collect participant feedback, followed by a single-blind, two-arm pilot RCT (n=44, 22 per arm). All participants receive four twice-weekly IV ketamine infusions (0.5 mg/kg); after infusions participants are randomised to brief narrative intervention plus minimally enhanced usual care or to minimally enhanced usual care alone.
Outcomes include feasibility benchmarks, safety/tolerability, pain interference, depressive symptoms, and measures to inform sample-size calculations for a larger RCT.
Initial open-label single-arm pilot (n=5): ketamine infusions followed by brief narrative intervention.
Four IV infusions of ketamine 0.5 mg/kg.
Brief narrative intervention delivered after ketamine infusions (pilot).
Second-phase experimental arm: all receive ketamine infusions then randomised to brief narrative intervention plus minimally enhanced usual care.
Four IV infusions of ketamine 0.5 mg/kg.
Minimally Enhanced Usual Care: educational reading materials regarding chronic back pain and depression.
Brief narrative intervention delivered after ketamine infusions.
Second-phase comparator arm: all receive ketamine infusions then randomised to minimally enhanced usual care only.
Four IV infusions of ketamine 0.5 mg/kg.
Minimally Enhanced Usual Care: educational reading materials regarding chronic back pain and depression.