Treatment Resistant Depression (TRD)NCT07563868
Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression
A study testing Psychedelic Integration Coaching in people with Treatment Resistant Depression (TRD), run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Depression (TRD)
- What is being tested?
- Psychedelic Integration Coaching
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2026to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Franklin King, MD contact
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital's Depression and Clinical Research program
Boston, Massachusetts, 02114
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Maren Nyer, PhD, 6176434897, mnyer@mgh.harvard.edu
Minna Behnan, BA, 6177247963, mbehnan@mgh.harvard.edu
About this study
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.
- Conditions
- Treatment Resistant Depression (TRD)
- Being tested
- Psychedelic Integration Coaching
- Keywords
- Psychedelic Coaching, Ketamine Coaching, Depression
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychedelic Integration CoachingBehavioural
Also called Coaching, Psychedelic 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.
| Study group | Role | What they receive |
|---|---|---|
| Psychedelic Coaching | Experimental | Not described Receives: Behavioral: Psychedelic Integration Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at Month 3
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start17 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant Depression (TRD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fireside Project
- Responsible party
- Principal investigator, Maren Nyer, Massachusetts General Hospital
- Investigators
- Maren Nyer, PhD, Principal investigator, Massachusetts General Hospital and Harvard Medical SchoolFranklin King, MD, Principal investigator, Massachusetts General Hospital and Harvard Medical SchoolDavid Mischoulon, MD/PhD, Principal investigator, Massachusetts General Hospital and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563868
- Sponsor's protocol ID
- 2025P002110
- Other IDs
- GR1001602
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression
- ClinicalTrials.gov ID
- NCT07563868
- Acronym / sponsor ID
- 2025P002110
- Conditions
- Treatment Resistant Depression (TRD)
- Keywords
- Psychedelic Coaching, Ketamine Coaching, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Fireside Project
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychedelic Coaching | Experimental | Behavioral: Psychedelic Integration Coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychedelic Integration CoachingAlso: Coaching, Psychedelic CoachingParticipation 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. | Behavioural | Psychedelic Coaching |
Primary outcome
To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.
Time frame: 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.
Time frame: 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.
9 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Screening, Baseline, Month 1, Month 2, Month 3, and 1-Month Post Study Completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Franklin King, MD contact
Maren Nyer, PhD principal investigator
Massachusetts General Hospital and Harvard Medical School
Franklin King, MD principal investigator
Massachusetts General Hospital and Harvard Medical School
David Mischoulon, MD/PhD principal investigator
Massachusetts General Hospital and Harvard Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychedelic Integration Coaching in people with Treatment Resistant Depression (TRD), run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maren Nyer, PhD (6176434897, mnyer@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment. (time frame: From enrollment to the end of treatment at Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.