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| ID | Type | Description | Link |
|---|---|---|---|
| GR1001602 | Other Grant/Funding Number | Fireside Project |
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| Name | Class |
|---|---|
| Fireside Project | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychedelic Coaching | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychedelic Integration Coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maren Nyer, PhD | Contact | 6176434897 | mnyer@mgh.harvard.edu | |
| Franklin King, MD | Contact | fking@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maren Nyer, PhD | Massachusetts General Hospital and Harvard Medical School | Principal Investigator |
| Franklin King, MD | Massachusetts General Hospital and Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital's Depression and Clinical Research program | Recruiting | Boston | Massachusetts | 02114 | United States |
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.
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |
| David Mischoulon, MD/PhD | Massachusetts General Hospital and Harvard Medical School | Principal Investigator |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| D001519 |
| Behavior |