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.
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.
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.
Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable.
Single group
Psychedelic Integration Coaching
BehavioralParticipation in the study will involve adding coaching sessions to existing ketamine maintenance treatment for patients receiving ongoing maintenance IV ketamine or IN esketamine treatment at MGH's Ketamine Clinic. If participants are eligible, they will be invited to participate in 12 weekly, 50-minute one-on-one coaching sessions conducted via Zoom. These sessions are designed to help participants process and integrate their experiences with ketamine treatment, to support personal growth and symptom improvement. The coaching is non-clinical, collaborative, and participant-directed, and is provided by trained psychedelic integration coaches from the Fireside Project. Throughout the 3-month coaching period and again at a 1-month follow-up, participants will complete monthly study visits that include brief remote assessments with a study clinician, along with additional self-report questionnaires. These visits will take approximately 1 to 2 hours, depending on the time point.
To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.
We will assess the feasibility of coaching, as indexed by at least 80% of participants (16 of 20 participants) completing 10 out of 12 coaching sessions. The investigators will also review all assessment procedures and calculate the percentage of completed assessments at each time point. In addition, the investigators will compute the number of participants for whom an AE occurred, along with their rate of occurrence, severity, and relationship to the study procedures.
To assess the acceptability of adjunctive coaching during ketamine/esketamine maintenance treatment.
Acceptability will be assessed by calculating the mean and standard deviation of participant-reported net-promoter scores, which will range from 0 (would not recommend) to 10 (would definitely recommend). Additional acceptability metrics will include qualitative and quantitative responses to the post-coaching survey and the end-of-coaching survey.
To explore whether coaching is associated with a reduction in the frequency of ketamine/esketamine maintenance treatments (measured in days) over the 3-month study period and 1-month follow-up.
Coaching will be associated with a reduction in the frequency of ketamine maintenance treatments (measured in days) assessed through chart review of patients' 3 treatments prior to enrollment in study and following completion of study.
To explore whether coaching is associated with a change in dose (measured in mg) and/or need for anxiolytic medications prior to ketamine/esketamine treatment.
Coaching will be associated with a reduction in the dose and/or need for anxiolytic medications (measured in mg) prior to ketamine/esketamine treatment, assessed through chart review of patients' 3 treatments prior to enrollment in study and following completion of study.
To explore whether adjunctive coaching is associated with a change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Coaching will be associated with a reduction in depressive symptoms (i.e., MADRS total scores) at Month 1, Month 2, and Month 3.
To explore whether coaching is associated with improvements in International Trauma Questionaire (ITQ) scores.
Coaching will lead to improvements in secondary outcomes, including the as International Trauma Questionnaire (ITQ) assessed at Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion.
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Massachusetts General Hospital
Lead sponsor
Fireside Project
Collaborator
