RecruitingNot Applicable

Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM)

Hong Kong180 participantsStarted 2025-02-24

Plain-language summary

The goal of this study is to learn whether combining repetitive transcranial magnetic stimulation (rTMS) with a computerized behavioral intervention (imagery cognitive bias modification, CBM-I) reduces negative interpretation bias and mild-to-moderate depressive symptoms. The study will also examine neural changes in the dorsolateral prefrontal cortex (DLPFC) and whether timing of interventions affects outcomes. The main questions it aims to answer are: Does active TMS reduce negative interpretation bias and depressive symptoms more than sham TMS? Is delivering CBM-I concurrently with TMS more effective than delivering it consecutively (separate sessions) at reducing negative bias and depressive symptoms? Do combined rTMS + CBM-I approaches produce greater neural changes and improved cognitive control over self-referential interpretation than controls? Researchers will compare active TMS versus sham TMS, and concurrent versus consecutive delivery of CBM-I, to test effects on negative bias and depressive symptoms. Participants will: Receive either active rTMS or sham TMS targeting the DLPFC Complete imagery CBM-I sessions either concurrently with TMS or in separate (consecutive) sessions Undergo assessments of negative interpretation bias, depressive symptoms, and neural measures before and after the intervention

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 years or above * Right-handed * Normal or corrected hearing and vision * Obtained primary education or above * Able to fluently read and understand Chinese * Beck's Depression Inventory-II (BDI-II) score ranging from 14-28 Exclusion Criteria: * History of severe physical disease, brain organic diseases, and neurological disorders (e.g., dementia, brain injury, stroke, epilepsy, Parkinson's disease) * History of substance use/ dependence/ withdrawal * Participants with intellectual disability based on IQ scores * Participants with contraindications for rTMS such as foreign metal bodies, implant devices (cochlear implants) or history (personal or family) of seizure * Participants who are not suitable to be scanned by magnetic resonance imaging (MRI) machine (e.g., claustrophobic, pregnant, metal in the body, hearing aids)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines two treatments — rTMS and Cognitive Bias Modification — and tests them both at the same time and one after the other; can you help me understand what that means practically for how many sessions I'd be attending and how demanding the schedule might be for my daily life?
2Since this trial is listed as Phase NA, which often means it's more of a research or feasibility study than a standard treatment trial, what does that tell us about how much is already known about the safety and effectiveness of combining rTMS with Cognitive Bias Modification for major depression?
3The study is measuring changes in resting-state brain activity using fMRI — does that mean I'd need to have MRI scans, and are there any reasons related to my health history that might make that a concern?
4Given that one of the main things being measured is 'cognitive bias,' which relates to patterns in how I process information, would you be able to explain what that means for my specific symptoms and whether addressing it is likely to be relevant to my type of depression?
5Before I consider this trial, do you think there are standard treatments for major depressive disorder that I should try first, or would enrolling in this study be a reasonable path to discuss given where I am in my treatment journey?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognitive Bias

Timeframe: "From enrollment to the end of treatment at 4 weeks"

Depressive Symptoms

Timeframe: "From enrollment to the end of treatment at 4 weeks"

Resting State functional MRI

Timeframe: "From enrollment to the end of treatment at 4 weeks"

Trial details

NCT IDNCT07636694

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Richard Liu Mr. Liu

+85290971398 richliu18@connect.hku.hk

View on ClinicalTrials.gov More Depression - Major Depressive Disorder trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.