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

NCT07636694 | Recruiting

• 1 other identifier: EA230645
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Depression - Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• Cognitive Bias

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

  "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

  "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

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

Secondary Outcomes (8)

• Subjective Well Being

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

• Sleep Quality

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

• Anxiety Symptoms

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

• Structural MRI

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

• Rumination Symptoms

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

Study Arms (3)

CC-R-CBM

ACTIVE COMPARATOR

Concurrent, Real TMS, CBM

Device: TMS; Behavioral: Cognitive Bias Modification

CC-S-CBM

SHAM COMPARATOR

Concurrent, Sham TMS, CBM

Behavioral: Cognitive Bias Modification; Device: Sham TMS

CS-R-CBM

ACTIVE COMPARATOR

Consecutive, Real TMS, CBM

Device: TMS; Behavioral: Cognitive Bias Modification

Interventions

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.

CC-R-CBM; CS-R-CBM

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.

CC-S-CBM

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.

CC-R-CBM; CC-S-CBM; CS-R-CBM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

InnoCentre of Clinical Neuropsychology, The University of Hong Kong

Quarry Bay, Hong Kong Island, Hong Kong

RECRUITING

Central Study Contacts

Richard Liu Mr. Liu

CONTACT

+85290971398; richliu18@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr Richard Liu - HKU-KCL Joint PhD Programme PhD Candidate

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: June 9, 2026
• Study Start: February 24, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

HK (1)