Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM) (TMS CBM)
4 juni 2026 uppdaterad av: Richard Liu, The University of Hong Kong
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
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
180
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Richard Liu Mr. Liu
- Telefonnummer: +85290971398
- E-post: richliu18@connect.hku.hk
Studieorter
-
-
Hong Kong Island
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Quarry Bay, Hong Kong Island, Hong Kong
- Rekrytering
- InnoCentre of Clinical Neuropsychology, The University of Hong Kong
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Kontakt:
- Richard Mr. Liu
- Telefonnummer: +85290971398
- E-post: richliu18@connect.hku.hk
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: CC-R-CBM
Concurrent, Real TMS, CBM
|
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.
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 Comparator: CC-S-CBM
Concurrent, Sham TMS, CBM
|
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.
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.
|
|
Aktiv komparator: CS-R-CBM
Consecutive, Real TMS, CBM
|
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.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cognitive Bias
Tidsram: "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
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Depressive Symptoms
Tidsram: "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
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Resting State functional MRI
Tidsram: "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
|
"From enrollment to the end of treatment at 4 weeks"
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Subjective Well Being
Tidsram: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Subjective Well-Being Scale Tool: Qualtrics Questionnaire Unit: Subjective Well-Being Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Sleep Quality
Tidsram: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Pittsburgh Sleep Quality Index (PSQI) Tool: Qualtrics Questionnaire Unit: Sleep Quality Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Anxiety Symptoms
Tidsram: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Beck Anxiety Inventory Task Tool: Qualtrics Questionnaire Unit: Anxiety Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Structural MRI
Tidsram: "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
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Rumination Symptoms
Tidsram: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Rumination Response Scale (RRS) Task Tool: Qualtrics Questionnaire Unit: Rumination Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Anhedonia Symptoms
Tidsram: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Dimensional Anhedonia Rating Scale Tool: Qualtrics Questionnaire Unit: Anhedonia Index
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Cognitive Measures-Attention
Tidsram: "From enrollment to the end of treatment at 4 weeks"
|
Measurement: Conners Continuous Performance Tests - III Tool: CPT-III (Computer Task) Unit: Reaction Time
|
"From enrollment to the end of treatment at 4 weeks"
|
|
Cognitive Measures-Attention
Tidsram: "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
|
"From enrollment to the end of treatment at 4 weeks"
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 februari 2025
Primärt slutförande (Beräknad)
1 december 2028
Avslutad studie (Beräknad)
1 december 2028
Studieregistreringsdatum
Först inskickad
28 april 2026
Först inskickad som uppfyllde QC-kriterierna
4 juni 2026
Första postat (Faktisk)
9 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- EA230645
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