rTMS With and Without Text4Support for the Treatment of Resistant Depression.
NCT ID: NCT05570344
Last Updated: 2025-03-25
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-02-01
2025-12-20
Brief Summary
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Detailed Description
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Methods: This study is a multicentered prospective, parallel-design, two-arm, rater-blinded randomized controlled pilot trial. The recruitment process is scheduled to last 12 months. It will involve active treatment for six weeks, observation, and a follow-up period of six months for participants in both arms of the study. In total, 200 participants diagnosed with TRD at rTMS care clinics in Edmonton, Alberta, and rTMS clinics in Halifax, Nova Scotia will be randomized to one of two treatment arms (rTMS sessions alone and rTMS sessions plus Text4Support intervention. Participants in each group will be made to complete evaluation measures at baseline, one month, three months, and six months. The primary outcome measure will be the mean change to scores on the Patient Health Questionnaire (PHQ-9). Patient service utilization data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses.
Interventions: Study participants will be randomized to one of the treatment interventions (rTMS alone or rTMS plus Text4Support). During the introductory visit to the study sites, participants in both arms of the study will be given a detailed orientation about the rTMS application, and all procedures and activities within each visit will be explained to them. As part of their participation in the rTMS program, all patients will be made to complete some standard measures. Participants will be invited to the various rTMS clinics a week before the commencement of the rTMS sessions to enable them to undergo motor threshold (MT) assessments. The MT assessment is essential in that it aids in the selection of the required stimulation intensity for each patient for inclusion in the treatment. MT assessment is a measure of the minimum intensity of TMS output needed to elicit a motor response in the participating TRD patients in at least 50% of all attempts.
The MT assessments will be conducted by the rTMS team of experts within the rTMS clinics in the various treatment centers and may consist of psychiatrists, nurses, and other healthcare professionals with the requisite knowledge to do so. Each TMS assessment session will take about 3-5 minutes, and the total time will be within 35-45 minutes. This visit timeline will be the same for all study participants. Overall, all study participants will be scheduled to receive 30 sessions of rTMS treatment for 6 weeks as pre-established by the Alberta Health Services Strategic Clinical Network for Addiction and Mental Health and Nova Scotia Health.
Additionally, participants in the rTMS plus Text4Support group of the study will be assisted by a study team member assigned that purpose to register on to the Text4Support program. The process will require all participants in this arm of the study to input their phone numbers into the Text4Support platform that will be used to deliver the daily messages. Starting a day after enrollment, participants will receive daily supportive text messages designed by mental health therapists, clinical psychologists, psychiatrists, and mental health service users. These messages are based on cognitive behavior therapy principles crafted to enhance positively the mood of its users with depressive symptoms and other related mental health problems of concern. The messages will be pre-programmed into a software program that will deliver the messages to participants automatically to the participants' mobile phones at 10 AM (Mountain Time) and 12 PM (Atlantic Time), and each participant will receive these messages continuously for 6 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enrolment in rTMS sessions alone
All study participants will be scheduled to receive 30 sessions of rTMS treatment for 6 weeks as pre-established by the Alberta Health Services Strategic Clinical Network for Addiction and Mental Health and Nova Scotia Health.
Repetitive 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.
Enrolment in rTMS sessions plus Text4Support
Participants in the rTMS plus Text4Support group of the study would be assisted by a study team member assigned that purpose to register onto the Text4Support program. The process would require all participants to input their phone numbers into the Text4Support platform that will be used to deliver the daily messages. Starting a day after enrollment, participants will receive daily supportive text messages designed by mental health therapists, clinical psychologists, psychiatrists, and mental health service users. These messages are based on cognitive behavior therapy principles crafted to enhance positively the mood of its users with depressive symptoms and other related mental health problems of concern. The messages will be pre-programmed into a software program that will deliver the messages to participants automatically to the participants' mobile phones at 10 AM (Mountain Time) and 12 PM (Atlantic Time), and each participant will receive these messages continuously for 6 weeks.
Repetitive 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.
Interventions
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Repetitive 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.
Repetitive 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Having diagnosis such as the following conditions (current unless otherwise stated): A neurological disorder, including a history of seizures, having primary or secondary tumors in the central nervous system, cerebrovascular disease, stroke, cerebral aneurysm, movement disorder,
* Having a current psychotic disorder such as substance-induced psychosis, psychotic disorder due to a medical condition, or MDD with psychotic features at the time of screening
* Having a current personality disorder that may hinder the patient's participation in this research or may have the potential of affecting cognition and ability to fully participate in the study.
* Having a learning disability as per identified through medical history or by the investigator during the assessment process.
* Participants involved in any drug or device clinical trial within the last six weeks before the screening visit and/or involvement in another clinical trial for the duration of this study.
* Pregnant and breastfeeding women.
* Identification and/or the sudden appearance of any condition or instance from the mentioned above and based on the expertise of the investigators that have the potential to hinder the progress and completion and/or become a confounding factor on the outcome assessments.
18 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Vincent Agyapong, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Division of Community Psychiatry, University of Alberta
Locations
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Edmonton Mental Health Clinic
Edmonton, Alberta, Canada
Nova Scotia Health - Abbie J. Lane Memorial Building QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Agyapong VIO, Juhas M, Ohinmaa A, Omeje J, Mrklas K, Suen VYM, Dursun SM, Greenshaw AJ. Randomized controlled pilot trial of supportive text messages for patients with depression. BMC Psychiatry. 2017 Aug 2;17(1):286. doi: 10.1186/s12888-017-1448-2.
Agyapong VI, Milnes J, McLoughlin DM, Farren CK. Perception of patients with alcohol use disorder and comorbid depression about the usefulness of supportive text messages. Technol Health Care. 2013;21(1):31-9. doi: 10.3233/THC-120707.
Agyapong VI, Mrklas K, Juhas M, Omeje J, Ohinmaa A, Dursun SM, Greenshaw AJ. Cross-sectional survey evaluating Text4Mood: mobile health program to reduce psychological treatment gap in mental healthcare in Alberta through daily supportive text messages. BMC Psychiatry. 2016 Nov 8;16(1):378. doi: 10.1186/s12888-016-1104-2.
Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
Tanner JA, Hensel J, Davies PE, Brown LC, Dechairo BM, Mulsant BH. Economic Burden of Depression and Associated Resource Use in Manitoba, Canada. Can J Psychiatry. 2020 May;65(5):338-346. doi: 10.1177/0706743719895342. Epub 2019 Dec 13.
Other Identifiers
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Pro00122696
Identifier Type: -
Identifier Source: org_study_id
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