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

2026년 7월 22일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
        • 수석 연구원:
          • Maren Nyer, PhD
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Franklin King, MD
        • 수석 연구원:
          • David Mischoulon, MD, PhD
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital's Depression and Clinical Research program

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Psychedelic Coaching
행동: 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.

다른 이름들:
  • 코칭
  • Psychedelic Coaching

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.
기간: 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.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Massachusetts General Hospital

협력자

Fireside Project

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 17일

기본 완료 (추정된)

2027년 4월 1일

연구 완료 (추정된)

2028년 4월 1일

연구 등록 날짜

최초 제출

2026년 3월 27일

QC 기준을 충족하는 최초 제출

2026년 4월 30일

처음 게시됨 (실제)

2026년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 22일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025P002110
  • GR1001602 (기타 보조금/기금 번호: Fireside Project)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다