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NCT Number: NCT07636694

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

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

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Key information

Conditions

Depression - Major Depressive Disorder

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

InnoCentre of Clinical Neuropsychology, The University of Hong Kong

Quarry Bay, Hong Kong Island, Hong Kong

Location status: Recruiting

Location contact

Richard Mr. Liu

CONTACT

[email protected]

+85290971398

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TMS

Device

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 Modification

Behavioral

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 TMS

Device

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.

Primary outcomes

  1. Cognitive Bias

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

    Measurement: Self-Referent Encoding Task Tool: PsychoPy Unit:Self-Referential Bias Index measured by positive and negative self-description affirmation

  2. Depressive Symptoms

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

    Measurement: Beck's Depressive Inventory-II Tool: Qualtrics Questionnaire Unit:Beck's Depressive Inventory-II Index

  3. Resting State functional MRI

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

    Measurement: resting-state functional MRI Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: functional dicom images

Secondary outcomes

  1. Subjective Well Being

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

    Measurement: Subjective Well-Being Scale Tool: Qualtrics Questionnaire Unit: Subjective Well-Being Index

  2. Sleep Quality

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

    Measurement: Pittsburgh Sleep Quality Index (PSQI) Tool: Qualtrics Questionnaire Unit: Sleep Quality Index

  3. Anxiety Symptoms

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

    Measurement: Beck Anxiety Inventory Task Tool: Qualtrics Questionnaire Unit: Anxiety Index

  4. Structural MRI

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

    Measurement: T1 Structural MRI Brain Image Tool: SIGNA Premier 3T wide-bore MRI scanner Unit: structural dicom images

  5. Rumination Symptoms

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

    Measurement: Rumination Response Scale (RRS) Task Tool: Qualtrics Questionnaire Unit: Rumination Index

  6. Anhedonia Symptoms

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

    Measurement: Dimensional Anhedonia Rating Scale Tool: Qualtrics Questionnaire Unit: Anhedonia Index

  7. Cognitive Measures-Attention

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

    Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Reaction Time

  8. Cognitive Measures-Attention

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Richard Liu Mr. Liu

CONTACT

[email protected]

+85290971398

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Acronym: TMS CBM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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