Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2023-09-25
2026-09-25
Brief Summary
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Detailed Description
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Follow-up data show TMS responders are highly variable with regard to how long they will sustain their benefits after completing the course of TMS; some will sustain response/remission for years while others will relapse after weeks or months. One randomized prospective study that aimed to prevent depressive episode relapse with maintenance TMS showed that a fixed (once per month) treatment schedule was not better than "watchful waiting" with threshold symptom-triggered TMS sessions. It is clear that there is not a "once size fits all" treatment schedule that should be applied for TMS maintenance therapy. Considering the wide range in durability of effect, a personalized approach is needed for determining when TMS maintenance treatments should be given. This study evaluates a convenient method for monitoring symptoms over time and a customized approach to scheduling maintenance TMS sessions on an individual-patient basis, with the "trigger" for re-introduction of TMS treatments driven by patient-specific change in MDD symptoms.
Ecological Momentary Assessment (EMA) involves measurement of symptoms in the real-life daily environment in which a patient lives, works, and functions, rather than in the research or clinic setting. One popular method for EMA involves using applications that are downloaded to a patient' smart phone or cloud-based software platforms which can sed a text message prompt to the patient at pre-set times so the patient can report about their symptoms. This study will evaluate whether a method that uses EMA assessments (weekly PHQ-9 surveys) and adaptive algorithm software can be used to schedule maintenance TMS sessions for MDD patients who have responded to a standard acute course of TMS therapy.
MDD patients who initially responded to a standard course of TMS at Butler Hospital will be invited to participate in this EMA study. Participants will be prompted to complete a brief symptom scale (PHQ-9) weekly via smart phone prompts. The software will compare their scores each week to a target score set for them (customized for each participant based on their response to the TMS acute course) and also compare the degree of change in their scores from week to week. The EMA software algorithm determines if and when a patient's score reaches a threshold that indicates maintenance TMS sessions may be appropriate.
Participants will be randomized to one of two groups: EMA only (EMA) or EMA with TMS maintenance sessions offered when their scores show a threshold level of increase relative to their "target" score (EMS+mTMS). While we routinely recommend patients avoid abrupt or significant changes to their psychotropic medication regimen following a successful acute course of TMS, both groups will continue to receive treatment as usual (TAU) for their depression in the form of pharmacotherapy or psychotherapy as prescribed or administered by their providers in the community. Other treatments will not be controlled, so mTMS sessions will thus be considered adjunctive therapy for those in the EMA+mTMS group who receive them. mTMS will be delivered as a "cluster" of 5 TMS sessions over 3-5 days, and will be offered only when there threshold level of MDD symptom re-emergence. Response to a cluster of maintenance sessions will also be assessed by EMA, with PHQ-9 surveys delivered at fixed intervals (2 days and 4 days) after the final session in the mTMS cluster is delivered.
The mTMS sessions will be delivered as standard-of-care, evidence-based protocols, with the selection of protocol for each session determined by TMS-trained treating physicians and based on consideration the patient's history of prior TMS response and tolerability, patient preference, etc. When two sessions are delivered in the same day, there will be a rest period of 45 minutes between each session.
Both EMA and EMA+mTMS groups will complete assessments by phone every 3 months to collect data about use of medications and utilization of other treatments. Patients in either group who experience significant MDD symptom relapse and meet coverage criteria for TMS re-treatment according to their health insurance policy may be referred for a standard insurance-covered TMS re-treatment course at any time during their participation in the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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EMA+Maintenance TMS
Weekly EMA monitoring and a cluster of 5 maintenance sessions scheduled if/when PHQ9 scores reach threshold, per algorithm. Participants continue other concurrent treatment as usual (TAU) with medications, psychotherapy, etc per outpatient clinicians.
EMA Monitoring
Weekly prompts to participants' smart phones for collection of PHQ-9 data
Scheduling Maintenance TMS sessions
When threshold score is reached, the participants is offered TMS maintenance treatments
EMA only
Weekly EMA monitoring without scheduled maintenance TMS. Participants in this arm may get TMS retreatment according to current standard of care (i.e., through their insurance coverage). Participants continue other concurrent treatment as usual (TAU) with medications, psychotherapy, etc per outpatient clinicians.
EMA Monitoring
Weekly prompts to participants' smart phones for collection of PHQ-9 data
Interventions
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EMA Monitoring
Weekly prompts to participants' smart phones for collection of PHQ-9 data
Scheduling Maintenance TMS sessions
When threshold score is reached, the participants is offered TMS maintenance treatments
Eligibility Criteria
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Inclusion Criteria
* PHQ-9 \<10
* Must have access to smart phone and ability to use electronic device
* Continues to meet standard eligibility criteria for clinical TMS procedures and have been medically cleared to receive treatments, per physician judgement.
18 Years
ALL
No
Sponsors
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Butler Hospital
OTHER
Responsible Party
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Principal Investigators
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Linda Carpenter, MD
Role: PRINCIPAL_INVESTIGATOR
Butler Hospital
Locations
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Butler Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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1503374
Identifier Type: -
Identifier Source: org_study_id