Actively Recruiting
Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression
Led by Massachusetts General Hospital · Updated on 2026-05-04
20
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
F
Fireside Project
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring whether adding psychedelic coaching can improve the effects of ketamine or esketamine maintenance treatment in people with treatment-resistant depression. This study is enrolling participants who are already receiving ongoing maintenance intravenous ketamine or intranasal esketamine (Spravato) at the Massachusetts General Hospital Ketamine Clinic. The aim is to understand if coaching can support personal growth and symptom improvement alongside existing treatments. Participants will take part in 12 weekly, 50-minute one-on-one coaching sessions conducted via Zoom. This coaching is non-clinical and participant-directed, provided by trained psychedelic integration coaches. The study includes a 3-month coaching period with monthly study visits for assessments, and a 1-month follow-up after the coaching ends. During the study, participants will complete remote assessments with a study clinician and fill out self-report questionnaires at screening, baseline, monthly during the intervention, and 1 month after completion. Researchers will measure feasibility and acceptability of coaching, changes in treatment frequency and dosage, and various symptom and well-being scales. Participation involves approximately 1 to 2 hours per monthly visit throughout the study period.
CONDITIONS
Brief Title
Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Ability to understand and provide informed consent
- Fluent in English (spoken and written)
- Willingness to have coaching sessions recorded via approved video platform
- QIDS-SR score of 11 or higher indicating moderate depressive symptoms
- Lifetime diagnosis of depressive disorder confirmed by MINI
- Currently in maintenance phase of ketamine or esketamine treatment
- Completed at least 3 maintenance treatments prior to screening with QIDS-SR score 11
- Receiving maintenance IV ketamine or intranasal esketamine at MGH Ketamine Clinic with recent treatment within past 8 weeks
- Established care with a mental health provider and agreement to share records if outside MGB system
You will not qualify if you...
- Unstable medical condition as determined by study clinician
- Significant neurocognitive impairment interfering with daily activities
- Newly started psychotherapy within past 3 months
- Any condition making participation unsafe or unsuitable per Principal Investigator
- Primary or unstable psychiatric condition interfering with participation
- Plan to switch between IV ketamine and intranasal esketamine during study
- Suicidality with a plan to act within next 6 months
- Reduction of 25% or more in QIDS total score from screening to baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 3 months
Participants receive 12 weekly, 50-minute one-on-one coaching sessions via Zoom to support processing and integration of their ketamine treatment experiences. Monthly remote study visits include brief assessments and self-report questionnaires.
12 coaching sessions and 3 monthly remote study visits
Duration - 1 month
Participants complete a 1-month post-treatment follow-up with a remote study visit including assessments and questionnaires to evaluate ongoing effects of coaching.
1 remote follow-up visit
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital's Depression and Clinical Research program
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Maren Nyer, PhD
F
Franklin King, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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