Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Psychedelic Coaching
干预措施: Psychedelic Integration Coaching (Behavioral)
结局指标
主要结局
To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.
时间窗: 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.
To assess the acceptability of adjunctive coaching during ketamine/esketamine maintenance treatment.
时间窗: 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.
次要结局
- 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.(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.(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.(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.(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.(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.(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.(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.(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.(Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion)
研究者
Maren Nyer
Principal Investigator
Massachusetts General Hospital