RecruitingNot ApplicableNCT05570344

rTMS With and Without Text4Support for the Treatment of Resistant Depression.

Repetitive Transcranial Magnetic Stimulation With and Without Text4Support for the Treatment of Resistant Depression: Patient-centered Multicentral Randomized Controlled Pilot Trial. Protocol.


Sponsor

University of Alberta

Enrollment

200 participants

Start Date

Feb 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a multicenter prospective, parallel design, two-arm, rater-blinded randomized controlled pilot trial. Participants will be randomly assigned to one of two treatment conditions. In the first condition, treatment consists of rTMS sessions combined with Text4Support. The second condition is made up of the treatment as usual (rTMS sessions alone). The recruitment process is scheduled to last 12 months. It will involve active treatment for six weeks and follow-up period observation periods of 1,3, and 6 months for participants in both arms of the study. Participants will be recruited from four different centers for this project. Two centers (the Addiction and Mental Health clinic and the Alberta day hospital) will be from the large, sociodemographic diverse city of Edmonton in Alberta Western Canada. The remaining two centers will be in Halifax and Annapolis Valley in Nova Scotia, Canada.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain stimulation treatment called rTMS (repetitive transcranial magnetic stimulation) — with and without supportive text messages — for people with depression that hasn't responded to at least two antidepressant medications. rTMS uses magnetic pulses to stimulate areas of the brain involved in mood. **You may be eligible if...** - You are 18 or older - You have been diagnosed with major depressive disorder (MDD) and have tried at least 2 antidepressant treatments without enough benefit - You speak English and have access to a smartphone for text messages - You are willing to sign an informed consent form **You may NOT be eligible if...** - You have a neurological disorder or certain other psychiatric diagnoses - You are under 18 - Your doctor determines you are not a suitable candidate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)

rTMS uses powerful (1.0-2.5 Tesla), focused magnetic field pulses to induce electrical currents in neural tissue noninvasively, via an inductor coil placed against the scalp.

DEVICERepetitive Transcranial Magnetic Stimulation (rTMS) Plus Text4Support

rTMS uses powerful (1.0-2.5 Tesla), focused magnetic field pulses to induce electrical currents in neural tissue noninvasively, via an inductor coil placed against the scalp. Text4Support: Text4Support is one of the ResilienceNHope suites of supportive text messaging programs delivered by the Global Psychological eHealth Foundation \[80\]. The program allows users to receive daily supportive text messages which have been written by a team of cognitive-behavioral therapists and mental health professionals in collaboration with users of mental health services. The aim of this Text4Support depression program is to enhance positively the mood of patients with clinical depression. The program operates through the use of positive reinforcement to correct distorted or negative thought patterns.


Locations(2)

Edmonton Mental Health Clinic

Edmonton, Alberta, Canada

Nova Scotia Health - Abbie J. Lane Memorial Building QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

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NCT05570344


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