Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
- Conditions
- Emotion Regulation
- Interventions
- Device: BCI
- Registration Number
- NCT03696667
- Lead Sponsor
- Institute of Mental Health, Singapore
- 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.
- Detailed Description
In this project, we will leverage on a locally developed electroencephalograph (EEG)-based BCI technology for decoding affective states of the brain, and thereby develop a closed-loop sensing and stimulation mechanism. The technology uses advanced neural signal computing on the EEG in real-time and audio feedback using a machine learning model that associates individual user's EEG characteristics in relation to music-emotion features. The system is portable and will allow emotion regulation training to be done outside of hospital setting with ease thus potentially addressing the treatment gap for MDD in the elderly.
This is a two group randomized study. One group will undergo the intervention which is 24 sessions of BCI emotion regulation training (i.e. listening to music with audio feedback to regulate emotions towards positive affect) over an 8-week period. The control group will undergo 8 weeks of music sessions, without any emotion regulation training. Both groups will undergo pre- and post- psychometric assessments looking at cognition, quality of life, functioning and emotional states. This study will also carry out functional MRI of the brain before and after 8 weeks of either training (intervention) or music music session (control) to examine changes associated with the affective BCI training. Study findings derived from psychometric assessments, EEG analysis and neuroimaging will provide evidences on efficacy and usability of this technology.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- English-speaking
- Geriatric Depression Scale score of 4 and below
- Fit to provide informed consent
- Able to travel to study site independently
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Affective BCI training BCI 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.
- Primary Outcome Measures
Name Time Method Emotion regulation questionnaire (ERQ) Week 0 and Week 9 To evaluate change in ERQ scores
Positive and Negative Affect Scale (PANAS) Week 0 and Week 9 To evaluate change in PANAS score
- Secondary Outcome Measures
Name Time Method Brief Assessment of Cognition - Short form Week 0 and Week 9 To evaluate changes in neurocognition
Geriatric Depression Scale (GDS) Week 0 and Week 9 To evaluate change in GDS score
Positive Mental Health (PMH) instrument Week 0 and Week 9 To evaluate change in PMH score
Body Awareness Questionnaire (BAQ) Week 0 and Week 9 To evaluate change in BAQ
Subjective Happiness Scale Week 0 and Week 9 To evaluate change in SHS
Connor-Davidson Resilience Scale 25 (CD-RISC-25) Week 0 and Week 9 To evaluate change in CD-RISC-25 score
The Frenchay Activities Index (FAI) Week 0 and Week 9 To evaluate change in FAI scores
Medical Outcomes Study: 20-item short form survey instrument Week 0 and Week 9 Outcome rating scale After each BCI session during Weeks 1 to 8 Usability questionnaire At the end of Week 8 Participants in the intervention group will rate statements regarding their satisfaction and ease of use of the training components on a 7-point Likert scale
Trial Locations
- Locations (2)
Duke-NUS Medical School
🇸🇬Singapore, Singapore
Institute of Mental Health
🇸🇬Singapore, Singapore