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

22 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Psychedelic Coaching
Comportamental: 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.

Outros nomes:
  • Coaching
  • Psychedelic Coaching

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.
Prazo: 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.
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

17 de abril de 2026

Conclusão Primária (Estimado)

1 de abril de 2027

Conclusão do estudo (Estimado)

1 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

27 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de abril de 2026

Primeira postagem (Real)

4 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2025P002110
  • GR1001602 (Número de outro subsídio/financiamento: Fireside Project)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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