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Procedure
rTMS + Text4Support for Depression
N/A
Recruiting
Led By Vincent Agyapong, MD, Ph.D
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether combining rTMS sessions with Text4Support is more effective than rTMS sessions alone in treating mental illness.
Who is the study for?
This trial is for adults over 18 with Major Depressive Disorder (MDD) who haven't improved after trying at least two antidepressant treatments. They must understand English, be able to use a smartphone for texts, and give written consent. It's not for those under 18, pregnant or breastfeeding women, people with learning disabilities, psychotic disorders, personality disorders that affect study participation, involvement in other trials recently, or certain neurological conditions.Check my eligibility
What is being tested?
The trial tests if adding Text4Support (a text messaging support system) to repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation treatment for depression, helps more than rTMS alone. Participants are randomly placed into one of these two groups and followed up at intervals after the six-week active treatment phase.See study design
What are the potential side effects?
Common side effects of rTMS include discomfort at the treatment site during sessions, headache afterwards and rarely seizures. The addition of Text4Support isn't expected to introduce physical side effects but may impact participants' emotional state due to content.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Patient Health Questionnaire (PHQ-9)
Secondary outcome measures
Columbia Suicide Severity Rating Scale
Generalized Anxiety Disorders Scale (GAD-7)
The World Health Organization - Five Well-Being Index (WHO-5)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enrolment in rTMS sessions plus Text4SupportExperimental Treatment1 Intervention
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.
Group II: Enrolment in rTMS sessions aloneActive Control1 Intervention
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.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
384,934 Total Patients Enrolled
18 Trials studying Depression
8,678 Patients Enrolled for Depression
Vincent Agyapong, MD, Ph.DPrincipal InvestigatorDivision of Community Psychiatry, University of Alberta
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have a neurological disorder or history of seizures.I am currently taking medication for mental health issues.I do not have a current psychotic disorder.I am 18 or older with depression and standard treatments haven't worked for me.You are an adult with Major Depressive Disorder (MDD) and have tried at least two standard antidepressant treatments during the current episode without success. You have a score of 10 or more on a depression rating scale. You are currently taking medications for mental health, and you understand and speak English. You have access to a smartphone and can receive text messages. You are willing to sign a form to show that you agree to participate in the study.I am currently taking medication for mental health issues.I am over 18 with depression and standard treatments haven't worked for me.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Enrolment in rTMS sessions plus Text4Support
- Group 2: Enrolment in rTMS sessions alone
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an ongoing enrollment period for this clinical investigation?
"According to clinicaltrials.gov, the recruitment period for this trial is closed as it was last edited on November 1st 2022. Nevertheless, there are currently 1295 other medical studies that actively require patients now."
Answered by AI
Who else is applying?
What state do they live in?
Alberta
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Edmonton Mental Health Clinic
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