Recruiting

rTMS with Text4Support

Sponsor:

University of Alberta

Code:

NCT05570344

Conditions

Depressive Disorder, Treatment-Resistant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Repetitive Transcranial Magnetic Stimulation (rTMS) Plus Text4Support

Study Details

Brief 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.

Conditions

Depressive Disorder, Treatment-Resistant

Study ID

NCT05570344

Start date

Feb 1, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • aged 18 and above and diagnosed with MDD based upon the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and who have at least failed two or more standard antidepressant treatments during the current episode. Participants may be on psychotropic medications including antidepressants, antipsychotics, benzodiazepines, and anticonvulsants. They must have a good understanding of the English language. Must have access to a smartphone and be able to receive and read text messages. Must be willing to provide written informed consent upon acceptance into the study.

Exclusion Criteria:

  • Patients below the age of 18.
  • 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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline ]
  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: 1 month ]
  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: 3 months ]
  • The Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Vincent Agyapong, MD, Ph.D

780-215-7771agyapong@ualberta.ca

Medard K Adu, BEd, MSc

5879376733medard@ualberta.ca

Locations

Edmonton Mental Health Clinic

Recruiting

Edmonton, Alberta, Canada, T6R 3P5

Contacts

Vincent Israel O Agyapong, PhD

17807144315agyapong@ualberta.ca

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

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E2

Contacts

Vincent Agyapong

vincent.agyapong@nshealth.ca

Principal Investigator:

Vincente Agyapong

More Information

Sponsor

University of Alberta

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Repetitive Transcranial Magnetic Stimulation
  • Treatment of Resistant Depression
  • Patient - Centered Randomized Controlled Pilot Trial
  • Supportive Text messages (Text4Support)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-04-13.