Depression - Major Depressive DisorderTMS CBMNCT07636694
Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM)
A study testing TMS and Cognitive Bias Modification in people with Depression - Major Depressive Disorder, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- TMS and Cognitive Bias Modification
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Feb 2025to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
InnoCentre of Clinical Neuropsychology, The University of Hong Kong
Quarry Bay, Hong Kong Island
Richard Mr. Liu, +85290971398, richliu18@connect.hku.hk
About this study
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:
Read more
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
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- TMS, Cognitive Bias Modification, Sham TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
The rTMS group will receive 10 Hz stimulation to the left DLPFC at an intensity of 120% of the resting motor threshold of the right abductor pollicis brevis (APB) muscle with 4 sec trains and 11 sec intertrain intervals for 3000 pulses.Specifically in our study, we combine both intervention, but applying them concurrently and consecutively between groups.
Cognitive Bias ModificationBehavioural
Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation. Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
Sham TMSDevice
The TMS coil will be rotated 90 degrees, and will not be delivering active stimulation to the participant. The intensity will be set to 30 and the TMS device will be active, generating enough sound effect but no real stimulation for sham control.
| Study group | Role | What they receive |
|---|---|---|
| CC-R-CBM | Active comparator | Concurrent, Real TMS, CBM Receives: Device: TMS; Behavioral: Cognitive Bias Modification |
| CC-S-CBM | Sham comparator | Concurrent, Sham TMS, CBM Receives: Behavioral: Cognitive Bias Modification; Device: Sham TMS |
| CS-R-CBM | Active comparator | Consecutive, Real TMS, CBM Receives: Device: TMS; Behavioral: Cognitive Bias Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Bias
Measurement: Self-Referent Encoding Task Tool: PsychoPy Unit:Self-Referential Bias Index measured by positive and negative self-description affirmation
Measured: "From enrollment to the end of treatment at 4 weeks"
Depressive Symptoms
Measurement: Beck's Depressive Inventory-II Tool: Qualtrics Questionnaire Unit:Beck's Depressive Inventory-II Index
Measured: "From enrollment to the end of treatment at 4 weeks"
Resting State functional MRI
Measurement: resting-state functional MRI Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: functional dicom images
Measured: "From enrollment to the end of treatment at 4 weeks"
Secondary outcomes (11)
Subjective Well Being
Measurement: Subjective Well-Being Scale Tool: Qualtrics Questionnaire Unit: Subjective Well-Being Index
Measured: "From enrollment to the end of treatment at 4 weeks"
Sleep Quality
Measurement: Pittsburgh Sleep Quality Index (PSQI) Tool: Qualtrics Questionnaire Unit: Sleep Quality Index
Measured: "From enrollment to the end of treatment at 4 weeks"
Anxiety Symptoms
Measurement: Beck Anxiety Inventory Task Tool: Qualtrics Questionnaire Unit: Anxiety Index
Measured: "From enrollment to the end of treatment at 4 weeks"
Structural MRI
Measurement: T1 Structural MRI Brain Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: structural dicom images
Measured: "From enrollment to the end of treatment at 4 weeks"
Rumination Symptoms
Measurement: Rumination Response Scale (RRS) Task Tool: Qualtrics Questionnaire Unit: Rumination Index
Measured: "From enrollment to the end of treatment at 4 weeks"
Anhedonia Symptoms
Measurement: Dimensional Anhedonia Rating Scale Tool: Qualtrics Questionnaire Unit: Anhedonia Index
Measured: "From enrollment to the end of treatment at 4 weeks"
Cognitive Measures-Attention
Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Reaction Time
Measured: "From enrollment to the end of treatment at 4 weeks"
Cognitive Measures-Attention
Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Correct Responses and Error responses will be used to calculate a performance index of sustained attention
Measured: "From enrollment to the end of treatment at 4 weeks"
Resting Motor Threshold
Measurement: Resting motor threshold at the individualized primary motor cortex motor hotspot Tool: Nexstim NBT® navigated TMS system Unit: Percentage of maximum stimulator output (%MSO)
Measured: "From enrollment to the end of treatment at 4 weeks"
TMS Electric-Field Dosimetry
Measurement: Electric-field strength and anatomical dosimetry at individualized M1 and DLPFC targets, including scalp-to-cortex distance and coil-orientation effects Tool: Nexstim NBT® neuronavigation and SimNIBS 4.6 finite-element modelling Unit: V/m, mm, and degrees
Measured: "From enrollment to the end of treatment at 4 weeks"
Electric-Field-Matched Stimulation Intensity
Measurement: Estimated DLPFC stimulation intensity required to match the M1 electric field at the individual resting motor threshold, including comparison with depth-based dosing Tool: Nexstim electric-field estimates, SimNIBS finite-element modelling, and scalp-to-cortex distance correction Unit: Percentage of maximum stimulator output (%MSO)
Measured: "From enrollment to the end of treatment at 4 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start24 Feb 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Liu, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636694
- Sponsor's protocol ID
- EA230645
- Acronym
- TMS CBM
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided