Recruiting

Ketamine with Coaching

Sponsor:

Massachusetts General Hospital

Code:

NCT07563868

Conditions

Treatment Resistant Depression (TRD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Psychedelic Integration Coaching

Study Details

Brief 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)

Study ID

NCT07563868

Start date

Apr 17, 2026

Status verified date

Jul, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 years or older at the time of informed consent/study enrollment.
2. Ability to understand and provide informed consent.
3. Fluent in English (spoken and written).
4. Willingness to have coaching sessions recorded via HIPAA-compliant MGB approved video-based platform.
5. Has a QIDS-SR score ≥ 11, indicating at least moderate depressive symptom severity at screening visit.
6. Lifetime diagnosis of a depressive disorder according to the MINI.
7. 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).
8. 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.
9. 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.
10. 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.

Exclusion Criteria:

1. Presence of an unstable medical condition, as determined by the study clinician.
2. Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study clinician judgment.
3. Newly initiated psychotherapy within the past 3 months.
4. Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable.
5. 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.
6. 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.
7. Suicidality determined by the judgment of the study clinicians at screen, with a plan to act in next 6 months.
8. A ≥25% reduction in QIDS total score from screen to baseline visit.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psychedelic Coaching

Interventions

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.

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

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital's Depression and Clinical Research program

Recruiting

Boston, Massachusetts, United States, 02114

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Maren Nyer, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Psychedelic Coaching
  • Ketamine Coaching
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-23.