NCT05936697

Brief Summary

Symptoms of depression and anxiety are common in older adults and are associated with poor outcomes and the risk of dementia. The prefrontal cortex (PFC) is crucial for emotion regulation. Poor PFC function may underlie subclinical depression and anxiety symptoms in older people, which could progress to clinical conditions. Neurofeedback training based on electroencephalography (EEG) or functional near-infrared spectroscopy (fNIRS) teaches individuals to self-regulate different aspects of brain activity and induce neurocognitive improvements. This proposed project will examine whether prefrontal EEG and fNIRS neurofeedback training programmes can enhance the mood and cognition of older adults with subclinical depression and anxiety.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

April 10, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

April 16, 2023

Last Update Submit

April 8, 2024

Conditions

Keywords

NeurofeedbackPrefrontal Cortex

Outcome Measures

Primary Outcomes (4)

  • Mood symptoms (post)

    Change in the HADS depression score (The Hospital Anxiety and Depression Scale (HADS) depression score has a minimum value of 0 and a maximum value of 21. Higher scores indicate a worse outcome. A score of 0-7 indicates normal, 8-10 indicates mild depression, 11-14 indicates borderline depression, and 15-21 indicates depression.)

    Within 1 week before the first training session, and within 1 week after the last training session

  • Mood symptoms (follow-up)

    Change in the HADS depression score at follow up (The Hospital Anxiety and Depression Scale (HADS) depression score has a minimum value of 0 and a maximum value of 21. Higher scores indicate a worse outcome. A score of 0-7 indicates normal, 8-10 indicates mild depression, 11-14 indicates borderline depression, and 15-21 indicates depression.)

    Within 1 week before the first training session, and within 1 month after the last training session

  • Anxiety symptoms (post)

    Change in the HADS anxiety score (The Hospital Anxiety and Depression Scale (HADS) anxiety score has a minimum value of 0 and a maximum value of 21. Higher scores indicate a worse outcome. A score of 0-7 indicates normal, 8-10 indicates mild anxiety, 11-14 indicates borderline anxiety, and 15-21 indicates anxiety.)

    Within 1 week before the first training session, and within 1 week after the last training session

  • Anxiety symptoms (follow-up)

    Change in the HADS anxiety score at follow-up (The Hospital Anxiety and Depression Scale (HADS) anxiety score has a minimum value of 0 and a maximum value of 21. Higher scores indicate a worse outcome. A score of 0-7 indicates normal, 8-10 indicates mild anxiety, 11-14 indicates borderline anxiety, and 15-21 indicates anxiety.)

    Within 1 week before the first training session, and within 1 month after the last training session

Secondary Outcomes (16)

  • Stroop (post; RT)

    Within 1 week before the first training session, and within 1 week after the last training session

  • Stroop (follow-up; RT)

    Within 1 week before the first training session, and within 1 month after the last training session

  • Stroop (post; accuracy)

    Within 1 week before the first training session, and within 1 week after the last training session

  • Stroop (follow-up; accuracy)

    Within 1 week before the first training session, and within 1 month after the last training session

  • Stroop (post; fNIRS)

    Within 1 week before the first training session, and within 1 week after the last training session

  • +11 more secondary outcomes

Study Arms (3)

Sham Group

SHAM COMPARATOR

During training, participants will be asked to follow the instructions on a computer screen and complete five rounds of task. Each round starts with a 30-s rest phase followed by 4.5 min of self-regulation phase. At the rest phase, a fixed cross will appear onscreen, and participants will be instructed to sit still and relax. At the regulation phase, they will be asked to make the person smile (as an intrinsic social reward) but without tips. The intensity of smiling will be manipulated by morphing photographs of a neutral and a happy face and will represent the increase in either frontal alpha asymmetry or frontal oxyhaemoglobin asymmetry. The values at the moment will be compared against the baseline. Participants will undergo a 3-min rest period before and after each training session to track changes in resting-state brain activity. In the sham condition, participants will receive visual feedback based on pre-recordings and/or other participants' recordings.

Other: Baseline Training

fNIRS Group

EXPERIMENTAL

During training, participants will be asked to follow the instructions on a computer screen and complete five rounds of task. Each round starts with a 30-s rest phase followed by 4.5 min of self-regulation phase. At the rest phase, a fixed cross will appear onscreen, and participants will be instructed to sit still and relax. At the regulation phase, they will be asked to make the person smile (as an intrinsic social reward) but without tips. The intensity of smiling will be manipulated by morphing photographs of a neutral and a happy face and will represent the increase in either frontal alpha asymmetry or frontal oxyhaemoglobin asymmetry. The values at the moment will be compared against the baseline. Participants will undergo a 3-min rest period before and after each training session to track changes in resting-state brain activity. In the fNIRS condition, participants will receive visual feedback based on their own fNIRS recordings.

Device: fNIRS

EEG Group

EXPERIMENTAL

During training, participants will be asked to follow the instructions on a computer screen and complete five rounds of task. Each round starts with a 30-s rest phase followed by 4.5 min of self-regulation phase. At the rest phase, a fixed cross will appear onscreen, and participants will be instructed to sit still and relax. At the regulation phase, they will be asked to make the person smile (as an intrinsic social reward) but without tips. The intensity of smiling will be manipulated by morphing photographs of a neutral and a happy face and will represent the increase in either frontal alpha asymmetry or frontal oxyhaemoglobin asymmetry. The values at the moment will be compared against the baseline. Participants will undergo a 3-min rest period before and after each training session to track changes in resting-state brain activity. In the EEG condition, participants will receive visual feedback based on their own EEG recordings.

Device: EEG

Interventions

fNIRSDEVICE

For fNIRS to be recorded by the wearable OctaMon+ system (Artinis Medical Systems, The Netherlands), two sources, each surrounded by four detectors positioned approximately 3 cm apart, will be placed on the scalp such that the two channels near the fissure on each side of the head are surrounded F3 and F4. Data will be sampled at 50 Hz.

fNIRS Group
EEGDEVICE

For EEG to be recorded by the ANT eego rt8 amplifier (ANT Neuro, Hengelo, The Netherlands), electrodes will be placed at Fp1, F3, F4, Fz, Fpz, Cz, GND (ground), lower VEOG, and on the two earlobes (references). Data will be collected at 2,048 Hz.

EEG Group

In the sham condition, participants will receive visual feedback based on pre-recordings and/or other participants' recordings. Participants will undergo a 3-min rest period before and after each training session to track changes in resting-state brain activity within and across sessions.

Sham Group

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (i) age of 60-79 years;
  • (ii) right-handedness as assessed using the short form of the Edinburgh Handedness Inventory (Veale, 2014);
  • (iii) a moderate or higher score on at least one of the depression and anxiety subscales (but not necessarily both) of the Depression Anxiety Stress Scale-21 (DASS-21), which has been shown to yield reliable and valid scores;
  • (iv) no history of neurological or psychiatric disorder;
  • (v) no history of traumatic brain injury requiring hospitalisation;
  • (vi) not currently using psychotropic medication;
  • (vii) ability to read Traditional Chinese text;
  • (viii) normal or corrected-to-normal vision; and
  • (ix) a score of at least 19 on the Hong Kong Montreal Cognitive Assessment

You may not qualify if:

  • does not fulfill any of the above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health and Social Sciences OF The Hong Kong Polytechnic University

Hong Kong, 000000, Hong Kong

RECRUITING

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  • Yochim, B. P., Mueller, A. E., June, A., & Segal, D. L. (2010). Psychometric properties of the geriatric anxiety scale: comparison to the beck anxiety inventory and geriatric anxiety inventory. Clinical Gerontologist, 34(1), 21-33.

    BACKGROUND
  • Zilverstand A, Sorger B, Sarkheil P, Goebel R. fMRI neurofeedback facilitates anxiety regulation in females with spider phobia. Front Behav Neurosci. 2015 Jun 8;9:148. doi: 10.3389/fnbeh.2015.00148. eCollection 2015.

    PMID: 26106309BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Kin Chung Michael Yeung

    The Education University of Hong Kong

    STUDY CHAIR

Central Study Contacts

Lai Man Jacqueline Chan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
During each training session, a cap adjusted to the participant's head size will be used to mount the EEG and fNIRS sensors. The hardware setup will be the same for all groups to ensure that both the participant and the experimenter are blinded to the training group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The participants will be randomly and equally assigned to one of three neurofeedback training groups: (1) sham, (2) EEG, and (3) fNIRS. Each participant will complete a neurophysiological assessment (1) before, (2) immediately after, and (3) 1 month after the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2023

First Posted

July 10, 2023

Study Start

February 15, 2023

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

April 10, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Personal information obtained for this study will be kept totally secret, and each participant will be assigned a unique serial number. We will properly secure their identity and privacy, as well as the personal data of all participants. The Confidentiality and Privacy Ordinance of The Hong Kong Polytechnic University shall protect and keep all medical data. Personal information will be stored in an encrypted file with just a code number to identify it. All personal data will be removed five years after the study project is completed. Research findings may be published in international academic publications or at conferences, but all personal information will be kept confidential.

Locations