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

22 de julio de 2026 actualizado por: Maren Nyer, Massachusetts General Hospital
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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

20

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Reclutamiento
        • Massachusetts General Hospital
        • Investigador principal:
          • Maren Nyer, PhD
        • Contacto:
        • Contacto:
        • Investigador principal:
          • Franklin King, MD
        • Investigador principal:
          • David Mischoulon, MD, PhD
      • Boston, Massachusetts, Estados Unidos, 02114
        • Reclutamiento
        • Massachusetts General Hospital's Depression and Clinical Research program

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Psychedelic Coaching
Conductual: 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.

Otros nombres:
  • Entrenamiento
  • Psychedelic Coaching

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.
Periodo de tiempo: From enrollment to the end of treatment at Month 3
We will assess the feasibility of coaching, as indexed by at least 80% of participants (16 of 20 participants) completing 10 out of 12 coaching sessions. The investigators will also review all assessment procedures and calculate the percentage of completed assessments at each time point. In addition, the investigators will compute the number of participants for whom an AE occurred, along with their rate of occurrence, severity, and relationship to the study procedures.
From enrollment to the end of treatment at Month 3
To assess the acceptability of adjunctive coaching during ketamine/esketamine maintenance treatment.
Periodo de tiempo: From enrollment to the end of treatment at Month 3
Acceptability will be assessed by calculating the mean and standard deviation of participant-reported net-promoter scores, which will range from 0 (would not recommend) to 10 (would definitely recommend). Additional acceptability metrics will include qualitative and quantitative responses to the post-coaching survey and the end-of-coaching survey.
From enrollment to the end of treatment at Month 3

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Periodo de tiempo: Baseline (3 ketamine treatments prior to enrollment), through the intervention (3 months after enrollment), and follow-up (1 month post-intervention)
Coaching will be associated with a reduction in the frequency of ketamine maintenance treatments (measured in days) assessed through chart review of patients' 3 treatments prior to enrollment in study and following completion of study.
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.
Periodo de tiempo: Baseline (3 ketamine treatments prior to enrollment), through the intervention (3 months after enrollment), and follow-up (1 month post-intervention)
Coaching will be associated with a reduction in the dose and/or need for anxiolytic medications (measured in mg) prior to ketamine/esketamine treatment, assessed through chart review of patients' 3 treatments prior to enrollment in study and following completion of study.
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.
Periodo de tiempo: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Coaching will be associated with a reduction in depressive symptoms (i.e., MADRS total scores) at Month 1, Month 2, and Month 3.
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.
Periodo de tiempo: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Coaching will lead to improvements in secondary outcomes, including the as International Trauma Questionnaire (ITQ) assessed at Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion.
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.
Periodo de tiempo: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Coaching will lead to improvements in secondary outcomes, including the as 5-item World Health Organization Well-Being Index (WHO-5) assessed at Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion.
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.
Periodo de tiempo: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Coaching will lead to improvements in secondary outcomes, including the as Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) assessed at Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion.
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.
Periodo de tiempo: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Coaching will lead to improvements in secondary outcomes, including the as Patient-Reported Outcomes Measurement Information System (PROMIS-29) assessed at Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion.
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.
Periodo de tiempo: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Coaching will lead to improvements in secondary outcomes, including the as Perceived Stress Scale (PSS) assessed at Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion.
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.
Periodo de tiempo: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Coaching will lead to improvements in secondary outcomes, including the as Self-Compassion Scale - Short Form (SCS-SF) assessed at Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion.
Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Massachusetts General Hospital

Colaboradores

Fireside Project

Investigadores

  • Investigador principal: Maren Nyer, PhD, Massachusetts General Hospital and Harvard Medical School
  • Investigador principal: Franklin King, MD, Massachusetts General Hospital and Harvard Medical School
  • Investigador principal: David Mischoulon, MD/PhD, Massachusetts General Hospital and Harvard Medical School

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de abril de 2026

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de abril de 2028

Fechas de registro del estudio

Enviado por primera vez

27 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de abril de 2026

Publicado por primera vez (Actual)

4 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025P002110
  • GR1001602 (Otro número de subvención/financiamiento: Fireside Project)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared due to the sensitive nature of the psychiatric and clinical data collected and the potential risk of participant re-identification. Study findings will be reported in aggregate form only to protect participant confidentiality.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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