EMA-Guided Maintenance TMS for Depression

NCT06145594 | Active Not Recruiting

• 1 other identifier: 1503374
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the use of ecological-momentary-assessment (EMA) as a method for scheduling maintenance treatments for patients with Major Depressive Disorder (MDD) who responded to an initial acute course of Transcranial Magnetic Stimulation (TMS). To assess symptom re-emergence and severity over time, the Patient Health Questionnaire-9 item (PHQ-9) will be administered weekly via a prompt with a link send to a participants' smart phones. Adaptive algorithm software will monitor each participant's PHQ-9 scores over time and determine when a threshold increase in symptoms has occured and maintenance TMS sessions should be offered. Participants in this study will be randomized to either receive weekly EMA (monitoring only) or weekly EMA with maintenance TMS sessions (scheduled as indicated by the EMA algorithm). Participation for each subject will last for one year, with maintenance TMS offered as an adjunct to ongoing treatment as usual (TAU) for depression, i.e., ongoing pharmacotherapy, psychotherapy.

Conditions

Major Depressive Disorder

Keywords

Transcranial Magnetic Stimulation (TMS); Ecological Momentary Assessment (EMA); Major Depressive Disorder (MDD); Maintenance Therapy

Outcome Measures

Primary Outcomes (1)

• Weeks in Response Range

  Number of weeks that participants' PHQ-9 total scores remained in their "response" range (equal to or less than their customized PHQ-9 target score+4)

  1 year

Study Arms (2)

EMA+Maintenance TMS

EXPERIMENTAL

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.

Other: EMA Monitoring; Other: Scheduling Maintenance TMS sessions

EMA only

ACTIVE COMPARATOR

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.

Other: EMA Monitoring

Interventions

EMA Monitoring OTHER

Weekly prompts to participants' smart phones for collection of PHQ-9 data

EMA only; EMA+Maintenance TMS

Scheduling Maintenance TMS sessions OTHER

When threshold score is reached, the participants is offered TMS maintenance treatments

EMA+Maintenance TMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary Major Depressive Disorder who responded (50% drop in score from pre-treatment baseline to final score on depression scale) to a standard acute course of TMS Therapy at Butler Hospital.
• 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.

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Linda Carpenter, MD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, 2 parallel groups (EMA or EMA+mTMS) with longitudinal follow-up (with EMA monitoring) over 1 year. open-label mTMS and other concurrent treatment as usual (TAU) for bother groups; Adjunct mTMS is offered if/when determined by software algorithm for EMA+mTMS group only.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: September 25, 2023
• Primary Completion: September 25, 2025
• Study Completion (Estimated): September 25, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)