Insomnia
Conditions
Interventions
Trial Group:Use of a VR-based smart meditation system developed in this project, based on Pico4Pro VR headset (integrated with TGAM EEG module and wrist-worn HRV sensor)
integrating Mindfulness-Based Cognitive Therapy (MBCT), Rational Emotive Behavior Therapy (REBT), Acceptance and Commitment Therapy (ACT), and biofeedback technology
three times per week, 45 minutes per session, for 8 weeks (total 24 sessions)
real-time monitoring of prefrontal a/ß/? waves and HRV indicators, with automatic adjustment of breathing guidance or virtual scenario difficulty based on user's physiological state (e.g., distraction
Control Group:Face-to-face traditional Cognitive Behavioral Therapy for Insomnia (CBT-I) conducted by psychologists trained uniformly
including standard modules such as sleep hygiene education, sleep restriction therapy, cognitive restructuring, and relaxation training
no use of any VR or biofeedback devices.
Sponsors
Inner Mongolia Autonomous Region Third Hospital (Mental Health Center)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old; 2. Diagnosed with insomnia according to DSM-5 and with a GAD-7 score >5; 3. PSQI score >5; 4. Signed the informed consent form; 5. Able to understand and follow the research procedure.
Exclusion criteria
Exclusion criteria: 1. Severe physical or other severe mental illnesses; 2. Recent suicide or self-harm tendencies; 3. Pregnancy or lactation; 4. Contraindication or allergy to VR equipment; 5. Inability to follow procedures; 6. Having undergone similar biofeedback therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pittsburgh Sleep Quality Index (PSQI) Total Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) Score;Reduction Rate of Hamilton Anxiety Rating Scale (HAM-A);Objective Physiological Parameters of Heart Rate Variability (HRV) (RMSSD, LF/HF Ratio); | — |
Countries
China
Contacts
Public ContactGuo Zhiguo
Inner Mongolia Autonomous Region Third Hospital (Mental Health Center)
Outcome results
None listed