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

NCT07563868 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

  • Treatment Resistant Depression (TRD)

Interventions

BEHAVIORAL

Psychedelic Integration Coaching

Participation 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.

Sponsors & Collaborators

Principal Investigators

  • Maren Nyer, PhD · Massachusetts General Hospital and Harvard Medical School

  • Franklin King, MD · Massachusetts General Hospital and Harvard Medical School

  • David Mischoulon, MD/PhD · Massachusetts General Hospital and Harvard Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-17
Primary Completion
2027-04-01
Completion
2028-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563868 on ClinicalTrials.gov