Insomnia
Conditions
Brief summary
The goal of this clinical trial is to evaluate whether a virtually embodied artificial intelligence (AI) agent delivered via VR-enhanced digital cognitive behavioral therapy for insomnia (dCBT-I) can improve insomnia outcomes and treatment adherence in adults with insomnia. The main questions it aims to answer are: \- Does VR-enhanced dCBT-I with an embodied AI agent lead to greater improvements in insomnia symptoms compared to app-based dCBT-I with an AI chatbot at post-intervention and 3-month follow-up? Researchers will compare VR-enhanced dCBT-I with an embodied AI agent to app-based dCBT-I with an AI chatbot to see if the VR-enhanced intervention results in significantly improved clinical outcomes and adherence. Participants will: * Be randomly assigned to either the VR-enhanced AI agent intervention group or the app-based AI chatbot control group * Complete a digital cognitive behavioral therapy for insomnia (dCBT-I) program with either a virtually embodied AI agent (VR-based) or a chatbot-based application * Undergo assessments at baseline, post-intervention, and 3-month follow-up
Interventions
BEHAVIORALApp-based dCBT-I with AI chatbot
Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
BEHAVIORALVR-enhanced dCBT-I with embodied AI agent
Digital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults of Chinese ethnicity, aged between 18 and 65 years. * Presence of insomnia, as indicated by a score of 10 or higher on the ISI. * Meeting the DSM-IV-TR diagnostic criteria for insomnia disorder. The 1-month duration criterion in DSM-IV-TR rather than the 3-month criterion in DSM-V is adopted to broaden the clinical relevance of the study findings. * Willing to provide online informed consent to participate in the study. * Willing to comply with the requirements outlined in the study protocol. * Possession of a smartphone and consistent internet access for smartphone use. * Acceptance of the terms of service and privacy policies of the mobile apps used for intervention delivery.
Exclusion criteria
* A current or history of any sleep disorders other than insomnia disorder, such as narcolepsy, obstructive sleep apnea, and restless legs syndrome. * A current or history of mental retardation or neuropsychiatric disorders other than depression or anxiety or stress disorders (as they are considered treatment outcomes), including bipolar disorder, schizophrenia, and substance use disorder. * Presence of serious suicidality, demonstrated by ideation with a plan or a previous suicide attempt. * Currently receiving long-term pharmacological treatment, including sleep-promoting agents. * Currently undergoing structured psychotherapy. * A current or history of significant visual, auditory, or balance impairment. * A current or history of epilepsy * Subject who is preparing for pregnancy or pregnant * A current or history of any voice, speech, language disorders and learning difficulties. * A current or history of severe health conditions (e.g., stroke, heart attack) * Engaged in shiftwork or trans-meridian travel within the past 3 months or during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | the severity of insomnia symptoms |
| Insomnia Module in the Diagnostic Interview for Sleep Disorder (DISP) | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | the severity of insomnia symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep onset latency (SOL) | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | 7-day sleep diary |
| Wake after sleep onset (WASO) | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | 7-day sleep diary |
| Sleep efficiency (SE) | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | 7-day sleep diary |
| Total sleep time (TST) | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | 7-day sleep diary |
| The Pre-Sleep Arousal Scale | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | cognitive and somatic manifestations of arousal near bedtime Total score ranges from 8 to 40. Higher scores suggest increased cognitive and somatic arousal before sleep. |
| Ford Insomnia Response to Stress Test | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | personal vulnerability to stress-related insomnia Total score ranges from 9 to 36. Higher scores suggest a greater likelihood of stress-induced insomnia. |
| Reduced Morningness and Eveningness Questionnaire | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | Chronotype preference. Total score ranges from 4 to 25. Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype. |
| The Dysfunctional Beliefs and Attitudes about Sleep Scale | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | Faulty sleep-related beliefs and cognitions, which are cognitive aspects typically involved in the maintenance of insomnia. Total score range of 0 to 160, with higher scores indicating stronger dysfunctional beliefs about sleep. |
| Depression, Anxiety and Stress Scale - 21 Items | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | The DASS-21 contains 21 items in three subscales, which assess symptoms of depression, anxiety, and stress |
| Patient Health Questionnaire-9 | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | The severity of depressive symptoms. Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms. |
| General Anxiety Disorder-7 | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | The severity of anxiety symptoms. Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms |
| The Sleep Hygiene Index | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | The practice of sleep hygiene behaviors. Total score ranges from 0 to 52. Higher scores reflect poorer sleep hygiene practices. |
| The Multidimensional Fatigue Inventory | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | Five dimensions of fatigue (general fatigue, physical fatigues, mental fatigue, decreased motivation, and decreased activities). Total score ranges from 20 to 100. Higher scores indicate greater fatigue levels. |
| Sleep Self-Efficiency Scale | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | A 9-item scale evaluating abilities such as falling asleep quickly, returning to sleep after waking, and preventing a poor night's sleep from disrupting daily activities. |
| Revised Attitudes Toward Internet Questionnaire | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | evaluates users' psychological, behavioral, and emotional responses to being online. |
| Credibility and expectancy questionnaire | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | measure a participant's treatment credibility and outcome expectancy in therapy. |
| Motivation to Change Sleep Behaviors questionnaire | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) | Assess the level of motivation to change sleep behaviors. |
| Acceptability E-scale questionnaire | post-intervention (1-month after baseline) | evaluate patients' impressions of computerized or e-health programs. |
| The Embodied Conversational Agents Trust Questionnaire | post-intervention (1-month after baseline) | measure a user's trust in a virtual agent or avatar. It evaluates trust across two dimensions: perceived credibility and perceived benevolence. |
| Adherence questionnaire | post-intervention (1-month after baseline) | Assess the frequency of engagement in, and adherence to, the behavioral strategies and sleep-related recommendations taught during the program. |
| User survey | post-intervention (1-month after baseline) | Measure perceived system usability, safety, interactivity, personalization, and overall user experience. |
Countries
Hong Kong
Contacts
CONTACTDr. Tim MH Li
CONTACTMs. Phoebe K.Y. Chan
Outcome results
None listed