Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression (NCT07563868) | Clinical Trial Compass
RecruitingNot Applicable
Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression
United States20 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18 years or older at the time of informed consent/study enrollment.
✓. Ability to understand and provide informed consent.
✓. Fluent in English (spoken and written).
✓. Willingness to have coaching sessions recorded via HIPAA-compliant MGB approved video-based platform.
✓. Has a QIDS-SR score ≥ 11, indicating at least moderate depressive symptom severity at screening visit.
✓. Lifetime diagnosis of a depressive disorder according to the MINI.
✓. 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).
✓. 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.
Exclusion criteria
✕. Presence of an unstable medical condition, as determined by the study clinician.
✕. Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study clinician judgment.
✕. Newly initiated psychotherapy within the past 3 months.
✕
What they're measuring
1
To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.
Timeframe: From enrollment to the end of treatment at Month 3
2
To assess the acceptability of adjunctive coaching during ketamine/esketamine maintenance treatment.
Timeframe: From enrollment to the end of treatment at Month 3
. Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable.
✕. 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.
✕. 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.
✕. Suicidality determined by the judgment of the study clinicians at screen, with a plan to act in next 6 months.
✕. A ≥25% reduction in QIDS total score from screen to baseline visit.