Home-based virtual reality scenic relaxation for patients with insomnia and anxiety: a single-arm feasibility and safety study

Insomnia commonly co-occurs with anxiety, and pre-sleep arousal may sustain both conditions. Virtual reality-based relaxation can help to downregulate arousal before sleep. There is limited access to cognitive behavioral therapy for insomnia, and few studies have examined VR relaxation in routine clinical practice. The study aimed to evaluate the feasibility and safety of a 4-week home-based virtual reality scenic relaxation intervention for outpatients with chronic insomnia and anxiety symptoms, and to explore changes in anxiety, depression, and sleep. We conducted a single-arm, pre-post feasibility study at an outpatient clinic. Adults with chronic insomnia and co-occurring clinically significant anxiety symptoms (Generalized Anxiety Disorder-7 [GAD-7] [≥]5 and Pittsburgh Sleep Quality Index [PSQI] [≥]6) completed eight home virtual reality sessions (approximately 20 min each) over 4 weeks. Primary outcomes were feasibility (recruitment, retention, and adherence) and safety (virtual reality-related adverse events). The exploratory outcomes were changes in the GAD-7, Patient Health Questionnaire-9 [PHQ-9], and PSQI scores from baseline to 4 weeks. The analyses were primarily descriptive, with effect sizes and 95% confidence intervals reported. Of the 11 enrolled participants, 10 completed the study (retention 91%) and achieved 8/8 sessions. No serious adverse events occurred, and only mild, transient discomfort was reported by 3 of 10 participants (30%). The participants reported moderate-to-high levels of satisfaction with their experience and a moderate-to-high sense of immersion in the virtual reality environment. In exploratory analyses, mean (standard deviation) changes were -4.0 (2.8), -4.1 (4.5), and -2.0 (2.1) for GAD-7, PHQ-9, and PSQI, respectively. Most participants improved on [≥]1 outcome. Home-based virtual reality scenic relaxation is feasible, acceptable, and safe for participants with insomnia and anxiety, with exploratory indications of symptom improvement. Controlled trials are warranted to establish efficacy and inform optimal implementation. Trial registrationJapan Registry of Clinical Trials (https://jrct.niph.go.jp/; registry number: jRCT1032240289; date of registration: August 22, 2024).