RecruitingNAINTERVENTIONAL

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

This study aims to find better ways to treat depression when standard treatments haven't worked. It's testing a therapy called rTMS (repetitive transcranial magnetic stimulation), which uses magnetic pulses to stimulate specific parts of the brain. The researchers want to see if adding a text message support program, called Text4Support, to rTMS makes the treatment more effective than rTMS alone. Participants will be split into two groups: one receiving rTMS with text support, and the other receiving rTMS on its own. The study will follow people for six months to see how their depression symptoms change and if the text support makes a difference. It's a pilot study, meaning it's a first step to see if this approach is promising.

At a glance

Status

Recruiting

Phase

Sponsor

University of Alberta

Enrolment target

200

Start

01 Feb 2023

Estimated completion

31 Dec 2026

Depressive Disorder, Treatment-Resistant

What is this study about?

When people have depression that hasn't improved with typical treatments like medication, it's called 'treatment-resistant depression'. This can be very challenging, and doctors are always looking for new and better ways to help. This study is exploring a treatment called rTMS, which involves using magnets placed on the scalp to gently stimulate brain cells involved in mood. It's a non-invasive treatment, meaning it doesn't involve surgery or needles.

The main idea behind this study is to see if adding extra support through text messages can boost the effects of rTMS. This extra support, called Text4Support, might help people stick with their treatment and feel more supported. By comparing people who receive rTMS alone with those who get rTMS plus the text messages, researchers hope to learn if this combined approach leads to better results for mood and overall wellbeing.

This is a pilot study, which means it's an initial look to see if this combination therapy is promising. The results will help guide future, larger studies. The aim is to gather important information about how effective this combined treatment might be and to understand patients' experiences. The study is being carried out in different clinics in Canada, and it will involve observing participants for several months after their active treatment ends.

Key takeaways

Tests rTMS with and without text message support for resistant depression.
Compares two groups to see which approach works best for mood.
Treatment lasts six weeks, with a six-month follow-up period.
Aims to find better ways to help people with hard-to-treat depression.
You must have a smartphone and be able to receive texts to participate.
This is a pilot study, an initial step to explore effectiveness.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with major depression that hasn't gotten better after trying at least two different antidepressant medications. You also need to speak and understand English well, have a smartphone, and be able to send and receive text messages. It's important that you're willing to give your written consent to take part in the study.

There are also some reasons why you wouldn't be able to join. For example, if you're under 18, or if you have certain medical conditions like a history of seizures, a brain tumour, or a stroke. If you have been diagnosed with certain mental health conditions like a psychotic disorder, a personality disorder that might make it hard to participate, or a learning disability, you also wouldn't be able to take part.

Pregnant or breastfeeding women cannot join the study. Also, if you’re currently in another clinical trial or have been in one very recently, you might not be eligible. The study doctors will carefully check all these points to make sure the study is safe and suitable for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with major depression that hasn't improved after trying at least two different antidepressant medications?
Do you have a smartphone and can receive and read text messages?
Do you understand and speak English well?
Are you free from conditions like seizures, brain tumours, or current psychotic disorders?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be put into one of two groups by chance, like flipping a coin. One group will receive rTMS treatment sessions along with the Text4Support program, which involves receiving text messages. The other group will receive rTMS treatment sessions only. You won't know which group you are in, and neither will the people assessing your progress, to keep the results fair.

The active treatment period will last for six weeks, during which you'll have your rTMS sessions. Before treatment starts, you'll have an assessment to determine the right magnetic stimulation level for you. After the six weeks of treatment, the researchers will keep track of your progress for another six months through follow-up visits. These follow-up visits will be at one month, three months, and six months after your treatment finishes. During these visits, you'll complete questionnaires, like the PHQ-9, to help measure how you're feeling and whether your depression symptoms are improving. You'll be asked to come to one of the rTMS clinics in Canada for these appointments.

Potential risks and benefits

Participating in this study might offer a potential benefit if the rTMS treatment, especially with the added text support, helps improve your depression symptoms more effectively than current treatments you've tried. While rTMS is generally considered safe, some people might experience mild side effects like a headache, scalp discomfort, or facial twitching during treatment. Serious risks are rare but can include seizures. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care. The researchers will discuss all potential benefits and risks with you in detail before you decide to join.

Locations (2)

Edmonton Mental Health Clinic
Verified postcode
Edmonton, Canada· Recruiting
Nova Scotia Health - Abbie J. Lane Memorial Building QEII Health Sciences Centre
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is rTMS treatment?

rTMS, or repetitive transcranial magnetic stimulation, uses magnetic pulses to gently stimulate parts of the brain that help control mood. It's a non-invasive treatment done while you're awake.

What is Text4Support?

Text4Support is a program that sends supportive text messages to your smartphone. In this study, it's being used alongside rTMS to see if it helps boost the treatment’s effects.

How long will the study last if I join?

The active treatment part of the study lasts six weeks. After that, you'll have follow-up checks over six months to see how you're doing.

Will I know if I'm getting Text4Support or not?

No, you won't know which group you're in. This helps ensure the study results are as fair and unbiased as possible.

Where is this study taking place?

The study is being run at rTMS clinics in Edmonton, Alberta, and Halifax, Nova Scotia, in Canada.

How to find out more

Vincent Agyapong, MD, Ph.D

agyapong@ualberta.ca 780-215-7771 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.