Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression

NCT03696667 | Completed

• 1 other identifier: 2017/00297
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective is to examine the feasibility and efficacy of a locally developed brain-computer interface (BCI) based system training for regulating mood in healthy elderly. The investigators hypothesize that elderly who complete the training program will be better at regulating emotions as compared to controls, based on their ratings of the primary outcome measures.

Conditions

Emotion Regulation

Outcome Measures

Primary Outcomes (2)

• Emotion regulation questionnaire (ERQ)

  To evaluate change in ERQ scores

  Week 0 and Week 9

• Positive and Negative Affect Scale (PANAS)

  To evaluate change in PANAS score

  Week 0 and Week 9

Secondary Outcomes (10)

• Brief Assessment of Cognition - Short form

  Week 0 and Week 9

• Geriatric Depression Scale (GDS)

  Week 0 and Week 9

• Positive Mental Health (PMH) instrument

  Week 0 and Week 9

• Body Awareness Questionnaire (BAQ)

  Week 0 and Week 9

• Subjective Happiness Scale

  Week 0 and Week 9

Other Outcomes (1)

• Changes in functional MRI

  Week 0 and Week 9

Study Arms (2)

Affective BCI training

ACTIVE COMPARATOR

15 participants in the intervention group will undergo 24 sessions of BCI-based emotion regulation training over an 8-week period. Each session will take about 30-minute to complete where participants will listen to music with audio feedback to regulate emotions toward positive affect.

Device: BCI

Control group

NO INTERVENTION

15 participants in the control group will take part in 24 music sessions (with no audio feedback) over an 8-week period. Each session will take about 30-minute to complete.

Interventions

BCI DEVICE

As participants listen to the music, the EEG waves of their affective states and their variations detected in real-time is converted into an auditory signal providing direct feedback to participants about their affective states and assisting participants to learn and practice emotion regulation.

Affective BCI training

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking
• Geriatric Depression Scale score of 4 and below
• Fit to provide informed consent
• Able to travel to study site independently

You may not qualify if:

• Presence of hearing impairment
• Presence of any known neuropsychiatric disorders (e.g. dementia, epilepsy or mental retardation)
• Contraindications for MRI such as surgical clips, cardiac pacemakers, metal implants and plates, orthodontics and claustrophobia

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead
• Agency for Science, Technology and Research: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (2)

Duke-NUS Medical School

Singapore, 169857, Singapore

Location

Institute of Mental Health

Singapore, 539747, Singapore

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Jimmy Lee

  Institute of Mental Health, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: March 8, 2018
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)