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

Más betegség

• 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.
• 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.

Egyéb

• Newly initiated psychotherapy within the past 3 months.
• 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.

• 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.
• 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.
• 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.