Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.

National Taiwan University

Status: Enrolling

Conditions: Anxiety Disorders

Treatments: Device: AI-fNIRS neurofeedback device; Device: AI-fNIRS neurofeedback device with sham signals

Study type: Interventional

Funder types: Other

Identifiers

NCT05921773

202302110DINA

Details and patient eligibility

About

The objective of this subproject is to validate the efficacy of the fNIRS real-time anxiety monitoring and neurofeedback system. In the first year, the cerebral hemodynamics measured by commercial fNIRS during resting state and cognitive tasks from 60 generalized anxiety disorder (GAD) patients and 30 healthy subjects will be processed and analyzed using AI algorithms. The novel anxiety fNIRS biomarker will be identified and correlated to clinical anxiety scales (such as HARS and STAI). In the second year, the validity and responsiveness of the AI-fNIRS biomarker will be validated. The accuracy of using AI-fNIRS biomarker to predict the diagnosis of GAD (according to DSM-5) and anxiety rating scales will be calculated from 60 GAD patients and 30 healthy subjects. In the third year, a neurofeedback method using AI-fNIRS biomarkers to guide digital cognitive behavior therapy (dCBT) through visual/audio cues will be developed. A pilot study with 12 GAD patients will be performed to test the feasibility of mindfulness training during AI-fNIRS neurofeedback. In the fourth year, a large scale RCT will be performed to validate the therapeutic efficacy of AI-fNIRS neurofeedback dCBT in 40 patients with GAD. The protocol of using real-time AI-fNIRS biomarkers as a neurofeedback to augment mindfulness training will be optimized according to previous year.

Enrollment: 232 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Being diagnosed with generalized anxiety disorder (GAD) by psychiatrists based on DSM-V.
• Native Chinese speakers.
• Right-handers.
• Normal vision without or after correction.
• Normal hearing and verbal expression.
• Regular returns of medical or psychological intervention during participation.

Exclusion criteria

• Being diagnosed with other major neurological or mental disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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232 participants in 2 patient groups

GAD Patients with Intervention

Experimental group

Description:

The feedback group will get real neurofeedback about changes in anxiety-related cerebral hemodynamics. AI-fNIRS neurofeedback will be provided 3 times a week, for a total of 4 weeks.

Treatment:

Device: AI-fNIRS neurofeedback device

GAD Patients with Sham Controls

Sham Comparator group

Description:

The sham group will be shown playbacks of someone's real feedback sessions. Sham AI-fNIRS neurofeedback will be provided 3 times a week, for a total of 4 weeks.

Treatment:

Device: AI-fNIRS neurofeedback device with sham signals