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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding psychedelic coaching helps people whose depression has not improved with treatment. It is for people getting ongoing ketamine through a vein (IV) or esketamine nose spray (Spravato) at the Massachusetts General Hospital (MGH) Ketamine Clinic. Coaching sessions are added to their current treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older and can understand the study and agree to join.
  • You speak and write English fluently.
  • You agree to have coaching sessions recorded on a hospital-approved video platform that meets health privacy rules.
  • You have had a depressive disorder, confirmed by a mental health interview called the MINI.
  • Your score on the QIDS-SR depression survey is 11 or higher at screening, meaning at least moderate symptoms.
  • You have finished the first treatment series and had at least 3 ongoing treatments. Your medical records show QIDS-SR scores of 11 or higher at each of your 3 most recent treatments.
  • You get ongoing IV ketamine or esketamine nose spray at the MGH Ketamine Clinic. You had a treatment within the past 8 weeks and plan to keep getting care there during the study.
  • You have a mental health provider. If they are outside the MGB health system, you agree to sign a form allowing information to be shared with the study team.

Who can't join

  • The study clinician finds that you have a medical condition that is not stable.
  • You have serious memory or thinking problems that affect daily tasks and would interfere with joining the study.
  • You started talk therapy within the past 3 months.
  • The study leader finds any condition or situation that makes joining unsafe or unsuitable.
  • Another mental health condition is your main concern, is more serious than your depression, or is too unstable for you to take part.
  • You plan to switch between IV ketamine and esketamine nose spray during the study.
  • At screening, study clinicians find that you have suicidal thoughts with a plan to act within the next 6 months.
  • Your QIDS depression score drops by 25% or more between screening and the baseline visit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

MA