Evaluating Repetitive Transcranial Magnetic Stimulation With or Without Text4Support for Treating Resistant Depression in Adults A Multicenter Randomized Pilot Trial
Led by University of Alberta · Updated on 2026-04-13
200
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare the clinical effects of repetitive transcranial magnetic stimulation rTMS alone versus rTMS combined with the Text4Support program in people diagnosed with treatment-resistant depression TRD. It is a multicenter, rater-blinded randomized controlled pilot trial involving 200 participants from clinics in Alberta and Nova Scotia, Canada. The study evaluates how adding a daily supportive text messaging program may impact depression symptoms over usual rTMS treatment alone.
Participants will be randomly assigned to one of two groups receiving 30 sessions of rTMS over six weeks alone, or receiving the same rTMS treatment plus daily text messages sent through the Text4Support program. The texts are designed by mental health professionals and users, based on cognitive behavioral therapy principles, and aim to improve mood. Texts will be sent automatically twice daily for six weeks to participants in the combined group.
Participants will complete assessments at the start, and again at one, three, and six months after treatment begins. These include the Patient Health Questionnaire PHQ-9 to measure depression symptoms, along with anxiety, suicide severity, and well-being scales. Motor threshold assessments will determine stimulation intensity prior to treatment. The study will monitor participant progress and service use during treatment and follow-up periods, lasting a total of six months from enrollment.
CONDITIONS
Brief Title
rTMS With and Without Text4Support for the Treatment of Resistant Depression.
Research Team
V
Vincent Agyapong, MD, Ph.D
M
Medard K Adu, BEd, MSc
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Diagnosed with major depressive disorder based on DSM-5 criteria
Failed two or more standard antidepressant treatments during current episode
May be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines, and anticonvulsants
Good understanding of English language
Access to a smartphone and able to receive and read text messages
Willing to provide written informed consent upon acceptance into the study
You will not qualify if you...
Under 18 years of age
Current diagnosis of neurological disorders such as seizures, central nervous system tumors, cerebrovascular disease, stroke, cerebral aneurysm, or movement disorders
Current psychotic disorders including substance-induced psychosis, psychotic disorder due to medical condition, or major depressive disorder with psychotic features
Current personality disorder that affects cognition or study participation
Learning disability as identified by medical history or assessment
Participation in any drug or device clinical trial within six weeks before screening or during this study
Pregnant or breastfeeding women
Any condition that may hinder progress or confound outcome assessments based on investigator judgment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for motor threshold assessments about one week before treatment
Implementation
Duration - 6 weeks
Participants receive 30 sessions of repetitive transcranial magnetic stimulation (rTMS) over 6 weeks. Participants in one group also receive daily supportive text messages designed to enhance mood.
30 rTMS sessions over 6 weeks; daily text messages sent automatically for 6 weeks for participants in the Text4Support group
Follow-up
Duration - 6 months
Participants complete evaluation measures to assess progress at 1 month, 3 months, and 6 months after starting treatment.
3 assessment visits at 1, 3, and 6 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Evaluating Repetitive Transcranial Magnetic Stimulation With or Without Text4Support for Treating Resistant Depression in Adults A Multicenter Randomized Pilot Trial
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Published Research Related To This Trial
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A John Rush, Madhukar H Trivedi, Hicham M Ibrahim...
Cross-sectional survey evaluating Text4Mood: mobile health program to reduce psychological treatment gap in mental healthcare in Alberta through daily supportive text messages.
Vincent I O Agyapong, Kelly Mrklas, Michal Juhás...