Recruiting NCT07563868

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

No phase Interventional Treatment Resistant Depression (TRD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Psychedelic Integration Coaching.
Who it may be relevant to: Registry conditions: Treatment Resistant Depression (TRD). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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

Primary outcome measures

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]

Secondary outcome measures (9)

To explore whether coaching is associated with a reduction in the frequency of ketamine/esketamine maintenance treatments (measured in days) over the 3-month study period and 1-month follow-up. [Time frame: Baseline (3 ketamine treatments prior to enrollment), through the intervention (3 months after enrollment), and follow-up (1 month post-intervention)]
To explore whether coaching is associated with a change in dose (measured in mg) and/or need for anxiolytic medications prior to ketamine/esketamine treatment. [Time frame: Baseline (3 ketamine treatments prior to enrollment), through the intervention (3 months after enrollment), and follow-up (1 month post-intervention)]
To explore whether adjunctive coaching is associated with a change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. [Time frame: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
To explore whether coaching is associated with improvements in International Trauma Questionaire (ITQ) scores. [Time frame: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
To explore whether coaching is associated with improvements in 5-item World Health Organization Well-Being Index (WHO-5) scores. [Time frame: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
To explore whether coaching is associated with improvements in Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) scores. [Time frame: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
To explore whether coaching is associated with improvements in Patient-Reported Outcomes Measurement Information System (PROMIS-29) scores. [Time frame: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
To explore whether coaching is associated with improvements in Perceived Stress Scale (PSS) scores. [Time frame: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]
To explore whether coaching is associated with improvements in Self-Compassion Scale - Short Form (SCS-SF) scores. [Time frame: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion]

Eligibility criteria

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 2 centers

Massachusetts General Hospital's Depression and Clinical Research program — Boston
Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07563868 · 2025P002110 · GR1001602

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗