Coaching as an Adjunct to Ketamine Therapy for... — Clinical Trial Details

Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression

This non-randomised, single-group interventional trial (n=20) will assess the feasibility and acceptability of adding psychedelic integration coaching to ongoing maintenance ketamine treatment in adults with treatment-resistant depression (TRD). The study will enrol participants already receiving maintenance intravenous ketamine or intranasal esketamine at Massachusetts General Hospital and aims to explore whether coaching can support symptom improvement and personal growth alongside existing treatment. Participants will receive 12 weekly, 50-minute one-on-one coaching sessions delivered via Zoom by trained psychedelic integration coaches. The coaching is non-clinical, collaborative and participant-directed. Over the 3-month coaching period, and again at a 1-month follow-up, participants will attend monthly study visits with brief remote assessments by a study clinician and self-report questionnaires, with visits taking about 1 to 2 hours depending on the time point. The primary outcomes are feasibility and acceptability from enrolment through Month 3.

Detailed Description

This study is being conducted at Massachusetts General Hospital (MGH) to explore whether adding psychedelic coaching can enhance the effects of ketamine or esketamine maintenance treatment in individuals with treatment-resistant depression (TRD). The investigators are currently enrolling participants who are receiving ongoing maintenance intravenous (IV) ketamine or intranasal esketamine (Spravato) treatment at the MGH Ketamine Clinic. Participation in the study will involve adding coaching sessions to your existing ketamine maintenance treatment.

1. Age 18 years or older at the time of informed consent/study enrollment.
2. Ability to understand and provide informed consent.
3. Fluent in English (spoken and written).
4. Willingness to have coaching sessions recorded via HIPAA-compliant MGB approved video-based platform.
5. Has a QIDS-SR score ≥ 11, indicating at least moderate depressive symptom severity at screening visit.
6. Lifetime diagnosis of a depressive disorder according to the MINI.
7. In the maintenance phase of ketamine or esketamine treatment, defined as the period following the initial acute treatment series (typically 2 treatments per week for 3 weeks).
8. Patients must have completed at least 3 maintenance treatments prior to screening visit with a QIDS-SR score ≥ 11 noted from EPIC medical records from the 3 most recent maintenance treatments.
9. Currently receiving maintenance IV ketamine or intranasal esketamine at the MGH Ketamine Clinic, with at least one treatment administered within the past 8 weeks, and planning to continue to be an active patient at the MGH Ketamine Clinic for the duration of the study.
10. Has established care with a mental health provider (e.g., psychiatrist, therapist, or other licensed mental health clinician), and, if outside the MGB-healthcare system, agrees to sign a Release of Information form (ROI) with the study team.

1. Presence of an unstable medical condition, as determined by the study clinician.
2. Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study clinician judgment.
3. Newly initiated psychotherapy within the past 3 months.
4. Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable.
5. Any psychiatric condition that is currently primary, clinically predominant to their depression, or insufficiently stable such that it would interfere with study participation, per clinician judgment.
6. Plan to switch from IV ketamine treatment to intranasal esketamine or plan to switch from intranasal esketamine to IV ketamine treatment at any point during study.
7. Suicidality determined by the judgment of the study clinicians at screen, with a plan to act in next 6 months.
8. A ≥25% reduction in QIDS total score from screen to baseline visit.

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Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression

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