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Questions and Answers
What was the purpose of the mindfulness training in the study mentioned?
What was the purpose of the mindfulness training in the study mentioned?
Which criterion was NOT part of the exclusion criteria for patient recruitment in the study?
Which criterion was NOT part of the exclusion criteria for patient recruitment in the study?
What was the intravenous dose of ketamine hydrochloride used in the St. Michael’s Institutional Infusion Protocol?
What was the intravenous dose of ketamine hydrochloride used in the St. Michael’s Institutional Infusion Protocol?
What is a key aspect of the MBCT Protocol used in the study?
What is a key aspect of the MBCT Protocol used in the study?
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Which feasibility measure was NOT considered in the study?
Which feasibility measure was NOT considered in the study?
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How does Cognitive Flexibility impact cognitive-behavioral learning according to the text?
How does Cognitive Flexibility impact cognitive-behavioral learning according to the text?
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What is the primary focus of the Canada's first KAP trial for NeP?
What is the primary focus of the Canada's first KAP trial for NeP?
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What is a core-domain question addressed in the study?
What is a core-domain question addressed in the study?
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What will determine the feasibility of the Canada's first KAP trial for NeP?
What will determine the feasibility of the Canada's first KAP trial for NeP?
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What is being compared in the standard-care + online CBT – MM intervention study?
What is being compared in the standard-care + online CBT – MM intervention study?
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What scale is used to assess Patient Global Impression of Change (PGIC) in the trial?
What scale is used to assess Patient Global Impression of Change (PGIC) in the trial?
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What aspect is addressed by the Inductive Probes in the study?
What aspect is addressed by the Inductive Probes in the study?
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What is a potential outcome of synergies between ketamine response, CBT, and mindfulness?
What is a potential outcome of synergies between ketamine response, CBT, and mindfulness?
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In the context of the text, what is the suggested impact of CBT on ketamine therapy?
In the context of the text, what is the suggested impact of CBT on ketamine therapy?
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How are psychoactive effects of ketamine described in comparison to psychedelic effects?
How are psychoactive effects of ketamine described in comparison to psychedelic effects?
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What is the main benefit of combining CBT with Mindfulness in the context of Ketamine therapy?
What is the main benefit of combining CBT with Mindfulness in the context of Ketamine therapy?
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Which factor is NOT emphasized as part of patient recruitment criteria for ketamine-assisted psychotherapy?
Which factor is NOT emphasized as part of patient recruitment criteria for ketamine-assisted psychotherapy?
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How does Ketamine impact NMDA receptors?
How does Ketamine impact NMDA receptors?
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What potential benefit is implied by the text regarding mindfulness training in conjunction with ketamine therapy?
What potential benefit is implied by the text regarding mindfulness training in conjunction with ketamine therapy?
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How are positive effects suggested to be impacted if a patient experiences ketamine-induced anxiety during treatment?
How are positive effects suggested to be impacted if a patient experiences ketamine-induced anxiety during treatment?
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What is a common limitation in the treatment durability of Ketamine according to research literature?
What is a common limitation in the treatment durability of Ketamine according to research literature?
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How can patient recruitment criteria potentially impact Ketamine therapy outcomes?
How can patient recruitment criteria potentially impact Ketamine therapy outcomes?
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Which of the following is a potential benefit of mindfulness training in the context of pain management?
Which of the following is a potential benefit of mindfulness training in the context of pain management?
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How does compassion play a role as an analgesic and antidepressant in the context of Ketamine therapy?
How does compassion play a role as an analgesic and antidepressant in the context of Ketamine therapy?
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What is the primary purpose of the randomized controlled trial funded by the PSI Foundation?
What is the primary purpose of the randomized controlled trial funded by the PSI Foundation?
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Why is ketamine considered burdensome despite its potent short-term benefits?
Why is ketamine considered burdensome despite its potent short-term benefits?
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What is one of the four primary goals of the study investigating ketamine and psychotherapy synergy?
What is one of the four primary goals of the study investigating ketamine and psychotherapy synergy?
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Based on the text, what challenges do chronic pain therapies typically face?
Based on the text, what challenges do chronic pain therapies typically face?
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Why is the study mentioned significant in the context of chronic pain management?
Why is the study mentioned significant in the context of chronic pain management?
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What aspect leads to the growing burden of ketamine therapy mentioned in the text?
What aspect leads to the growing burden of ketamine therapy mentioned in the text?
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The Toronto Side Effects Scale is used to monitor adverse events per FDA regulations.
The Toronto Side Effects Scale is used to monitor adverse events per FDA regulations.
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The PROMIS Pain Interference - Short Form v1.1 assesses emotional functioning.
The PROMIS Pain Interference - Short Form v1.1 assesses emotional functioning.
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The Patient Health Questionnaire-9 (PHQ-9) is used to assess generalized anxiety disorder.
The Patient Health Questionnaire-9 (PHQ-9) is used to assess generalized anxiety disorder.
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The Pain Catastrophizing Scale (PCS) evaluates perceptions of pain improvement.
The Pain Catastrophizing Scale (PCS) evaluates perceptions of pain improvement.
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The St. Michael's Institutional Infusion Protocol uses an intravenous dose of ketamine hydrochloride.
The St. Michael's Institutional Infusion Protocol uses an intravenous dose of ketamine hydrochloride.
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The study involving standard-care + online CBT and Mindfulness-based Meditation (MM) intervention is funded by the PSI Foundation.
The study involving standard-care + online CBT and Mindfulness-based Meditation (MM) intervention is funded by the PSI Foundation.
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Ketamine therapy is considered burdensome due to its potent short-term benefits.
Ketamine therapy is considered burdensome due to its potent short-term benefits.
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The KAP trial for NeP aims to clarify mechanisms of change regarding chronic pain.
The KAP trial for NeP aims to clarify mechanisms of change regarding chronic pain.
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Psychotherapy synergy with ketamine is expected to have no significant impact on patient outcomes.
Psychotherapy synergy with ketamine is expected to have no significant impact on patient outcomes.
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Mindfulness training plays no role in the context of pain management according to the text.
Mindfulness training plays no role in the context of pain management according to the text.
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Study Notes
Study Protocol Overview
- Aims to investigate the feasibility and efficacy of ketamine-assisted psychotherapy (KAP) in patients with chronic neuropathic pain
- Combines ketamine infusions with cognitive-behavioral therapy (CBT) and mindfulness training
- Recruiting 30 patients with moderate-to-severe neuropathic pain from St. Michael's Hospital's chronic pain clinic
Ketamine-Assisted Psychotherapy (KAP)
- KAP combines ketamine infusions with psychotherapy to enhance analgesic effects and promote durable pain relief
- Ketamine is a rapid-acting antidepressant and pain reliever that acts on NMDA receptors
- Concurrent psychotherapy can enhance the durability of ketamine's analgesic effects
Study Design
- Participants will receive 12 weeks of treatment, including 3 ketamine infusions and 16 hours of phone-based CBT and mindfulness training
- Primary outcome measures include pain intensity, physical functioning, and emotional functioning
- Feasibility measures will assess recruitment rate, intervention adherence, patient withdrawal, and missing data
Patient Population
- Inclusion criteria: age 18 years and older, moderate-to-severe neuropathic pain, and a clinical diagnosis of neuropathic pain
- Exclusion criteria: pregnancy, psychiatric disorders, substance use disorder, poorly managed hypertension, and severe liver dysfunction
Outcome Measures
- Pain intensity: measured using the Numeric Rating Scale (NRS) and the Patient Global Impression of Change (PGIC) scale
- Physical functioning: measured using the PROMIS Pain Interference – Short Form v1.1
- Emotional functioning: measured using the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder 7-item (GAD-7) scale
Feasibility and Future Directions
- The study aims to determine the feasibility of conducting a larger definitive trial
- Results will inform the design of a larger trial and address the need for multidisciplinary pain management in Canada
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Description
Explore the impact of cognitive-behavioral therapy and mindfulness training on chronic pain patients during and after medical infusions. The study involved 30 participants recruited from St. Michael's Hospital's chronic pain clinic, with a focus on cognitive flexibility, pain-gate closure, and reducing negative reactivity.
