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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07563868
Status
Recruiting
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Conditions

  • Treatment Resistant Depression (TRD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psychedelic Integration Coaching — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psychedelic Coaching

Primary Outcome Measure

To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment. [ Time Frame: From enrollment to the end of treatment at Month 3 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Maren Nyer, PhD
[email protected]
6176434897
Minna Behnan, BA
[email protected]
6177247963
Maren Nyer, PhD (PRINCIPAL_INVESTIGATOR)
Franklin King, MD (PRINCIPAL_INVESTIGATOR)
David Mischoulon, MD, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital's Depression and Clinical Research programBostonMassachusetts02114-

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Massachusetts General Hospital· Boston, MAMassachusetts General Hospital's Depression and Clinical Research program· Boston, MA

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