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ACTIVE NOT RECRUITING
NCT06145594
NA

EMA-Guided Maintenance TMS for Depression

Sponsor: Butler Hospital

View on ClinicalTrials.gov

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.

Official title: Ecological Momentary Assessment-Guided Transcranial Magnetic Stimulation Maintenance Therapy for Prevention of Depression Relapse or Recurrence

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-09-25

Completion Date

2026-09-25

Last Updated

2024-12-04

Healthy Volunteers

No

Interventions

OTHER

EMA Monitoring

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

OTHER

Scheduling Maintenance TMS sessions

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

Locations (1)

Butler Hospital

Providence, Rhode Island, United States