Coaching with Ketamine Therapy for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether adding coaching to ketamine or esketamine treatment can benefit individuals with treatment-resistant depression (TRD). Participants will maintain their regular ketamine treatments and add coaching sessions to assess any improvement in their results. Suitable candidates include those currently receiving ketamine or esketamine treatments at Massachusetts General Hospital and are in the maintenance phase of their treatment. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance treatment outcomes for TRD.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, since the study involves adding coaching to your existing ketamine or esketamine treatment, it seems likely you can continue your current regimen.
What prior data suggests that psychedelic integration coaching is safe for individuals with treatment-resistant depression?
Research has shown that psychedelic integration coaching is generally safe. Although no specific study exists on this type of coaching, related research on psychedelic-assisted therapy indicates safety. For instance, studies on substances like psilocybin, MDMA, and LSD suggest they can improve mood and assist with mental health issues such as PTSD. These studies imply that with proper guidance, risks can be well-managed.
Psychedelic integration coaching involves working with a trained professional to help individuals understand and process experiences from psychedelic treatments. This approach adds an extra layer of support and safety. It is considered a promising way to enhance the benefits of treatments like ketamine for depression while keeping risks low.
In summary, while specific data on psychedelic coaching alone is limited, related research suggests it is a safe and supportive addition to treatment.12345Why are researchers excited about this trial?
Researchers are excited about the Coaching with Ketamine Therapy for Depression trial because it combines psychedelic integration coaching with ketamine therapy, offering a unique approach to treating depression. Unlike standard antidepressants, which often take weeks to show effects, ketamine can rapidly alleviate depressive symptoms, sometimes within hours. The integration coaching component provides personalized support to help patients process and integrate their experiences, potentially enhancing the therapeutic benefits of ketamine. This holistic approach could offer a quicker, more comprehensive treatment option for depression compared to traditional methods.
What evidence suggests that psychedelic coaching is effective for treatment-resistant depression?
Research has shown that combining psychedelics with therapy can improve mental health issues like treatment-resistant depression (TRD). Studies have found that this approach can greatly reduce symptoms of depression and anxiety. Specifically, one study reported significant improvements in depression through psychedelic-assisted therapy. In this trial, participants will receive Psychedelic Integration Coaching, which may enhance the effects of ketamine treatments for depression. Participants in integration groups have also experienced better emotional processing and increased self-compassion. Overall, evidence suggests that this coaching approach may enhance the benefits of ketamine therapy for depression.56789
Who Is on the Research Team?
Maren Nyer, PhD
Principal Investigator
Massachusetts General Hospital and Harvard Medical School
Franklin King, MD
Principal Investigator
Massachusetts General Hospital and Harvard Medical School
David Mischoulon, MD/PhD
Principal Investigator
Massachusetts General Hospital and Harvard Medical School
Are You a Good Fit for This Trial?
This trial is for adults (18+) with treatment-resistant depression who are already receiving ongoing maintenance ketamine or esketamine treatments at Massachusetts General Hospital. Participants must speak English, have moderate or worse depression symptoms, and be under the care of a mental health provider.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ongoing maintenance intravenous (IV) ketamine or intranasal esketamine (Spravato) treatment with adjunctive psychedelic coaching sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psychedelic Integration Coaching
Trial Overview
The study is testing whether adding psychedelic integration coaching sessions to regular ketamine or esketamine maintenance therapy can improve outcomes in people with hard-to-treat depression. Coaching will be added alongside usual medication treatments.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Fireside Project
Collaborator
Citations
Psychedelic-Assisted Psychotherapy—A Systematic Review ...
Results showed improved abstinence, relapse rates, craving, and anhedonia in the high dose group while both groups showed improvements in anxiety, depression, ...
Real-world effectiveness and safety of psychedelic ...
Psychedelic treatment data from 115 compassionate use patients were reported. · Psychedelic-assisted psychotherapy significantly reduced depression and anxiety.
3.
globalrph.com
globalrph.com/2025/10/psychedelic-therapy-in-2025-new-research-reveals-surprising-clinical-outcomes/Psychedelic Therapy In 2025 -New Research Reveals ...
Research through 2025 demonstrates robust effectiveness: 71% of PTSD patients experiencing lasting relief with MDMA-assisted therapy, 58% ...
Psychological Therapy Quantity and Depressive Symptom ...
This systematic review and meta-analysis examines the association between quantity of psychological therapy and symptom reduction in ...
Psychedelic treatment and mental health: Navigating a ...
New studies are shedding light on how psychedelics alter the brain to facilitate lasting improvements related to substance use disorders, PTSD, depression, ...
Efficacy and Safety of Psychedelics in Mental Disorder Cases
This umbrella review aims to evaluate the effectiveness and safety of psychedelic-assisted therapy—primarily psilocybin, MDMA, and LSD—across ...
Efficacy and safety of psychedelics for the treatment ...
Our analyses suggest that psychedelics reduce negative mood, and have potential efficacy in other mental disorders, such as substance-use disorders and PTSD.
Psychedelic-assisted therapy: science, safety, and regulation
Psychedelic-assisted therapy offers hope for depression and PTSD but carries risks. Learn about FDA regulations, safety, and the science ...
Psychedelic therapeutics in psychiatric conditions
Outcomes include clinical ratings of anxiety and depression and safety data. There are multiple phase 2 studies on GAD listed in the tracker ...
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