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Insomnia is a common sleep problem, which affects 9.4-38.2% of youths worldwide. Youth insomnia is linked to mental health problems, leading to substantial health and economic burden. The project aims to conduct an assessor-blind, randomized controlled trial to evaluate the efficacy of an app-based CBT-I with AI chatbot in reducing insomnia symptoms among youths, compared to an app-based CBT-I without AI chatbot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| app-based digital cognitive behavioral therapy for insomnia with AI chatbot | Experimental |
| |
| app-based digital cognitive behavioral therapy for insomnia without AI chatbot | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| app-based digital cognitive behavioral therapy for insomnia with AI chatbot | Behavioral | digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and patient-centered conversational agents |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | the severity of insomnia symptoms | a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| sleep onset latency (SOL) | 7-day sleep diary | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| wake after sleep onset (WASO) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction Scale | Treatment Satisfaction Scale includes 8 items with 5-point Likert scale. The total score ranges from 8 to 40. The higher the score means a higher satisfaction. | post-intervention (1-month after baseline) |
| Treatment Component Adherence |
Inclusion Criteria:
i. Youth aged 18 to 25 years (as defined by WHO and evidence on AI mental health chatbots only available for individuals aged 18 years and older)
ii. Online informed consent of participation in the study should be provided
iii. Willing to comply with the requirements of the study protocol
iv. The presence of moderate to severe insomnia measured by a score of 15 or above on the Insomnia Severity Index (ISI)
v. difficulties initiating, maintaining or nonrestorative sleep over a 1-month period
vi. Having access to a smartphone and consistent internet access for their smartphone
vii. Accepting the terms of service and privacy policies of the mobile apps used in the study for the delivery of the intervention
Exclusion Criteria:
i. A history of any sleep disorder(s) (other than insomnia disorder) such as narcolepsy, obstructive sleep apnea, and restless legs syndrome
ii. A history of any mental retardation or neuropsychiatric disorder(s) (other than depression and anxiety disorders as they are the secondary outcomes) such as bipolar disorder, schizophrenia, and substance use disorder
iii. Presence of serious suicidality as evidenced by ideation with a plan or an attempt
iv. Receiving any pharmacological treatment (including sleep promoting agents)
v. Receiving any structured psychotherapy
vi. Having shiftwork and trans-meridian travel in the past 3 months and during the intervention
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, the Chinese University of Hong Kong | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| app-based digital cognitive behavioral therapy for insomnia without AI chatbot | Behavioral | digital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents |
|
7-day sleep diary
| a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| sleep efficiency (SE) | 7-day sleep diary | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| Total sleep time (TST) | 7-day sleep diary | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| The Pre-Sleep Arousal Scale | 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. | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| The Cognitive Failures Questionnaire | self-reported failures in perception, memory, and motor function Total score ranges from 0 to 100. Higher scores indicate more self-reported cognitive lapses. | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| Ford Insomnia Response to Stress Test | personal vulnerability to stress-related insomnia Total score ranges from 9 to 36. Higher scores suggest a greater likelihood of stress-induced insomnia. | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| reduced Horne and Östberg Morningness and Eveningness Questionnaire | Chronotype preference. Total score ranges from 4 to 25. Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype. | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| The Dysfunctional Beliefs and Attitudes about Sleep Scale | 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. | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| Patient Health Questionnaire-9 | The severity of depressive symptoms. Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms. | a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| General Anxiety Disorder-7 | The severity of anxiety symptoms. Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms | a) baseline; b) interim during intervention (2-week after baseline); c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| The Sleep Hygiene Index | The practice of sleep hygiene behaviors. Total score ranges from 0 to 52. Higher scores reflect poorer sleep hygiene practices. | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| The Charlotte Attitudes Towards Sleep Scale | Perception and attitude towards sleep in youths. Total averaged score ranges from 1 to 7. Higher scores denote more positive attitudes about sleep. | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
| The Multidimensional Fatigue Inventory | 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. | a) baseline; c) post-intervention (1-month after baseline); d) 3-month after intervention (4-month after baseline); e) 6-month after intervention (7-month after baseline) |
Treatment Component Adherence Scale. 26 single-item, each item has a scoring between 1 to 5. |
| post-intervention (1-month after baseline) |
| Acceptability E-scale questionnaire | Measures the digital program was acceptable or not. Total scores range from 6 to 30. The higher the score means a more positive evaluation. | post-intervention (1-month after baseline) |
| The Embodied Conversational Agents Trust Questionnaire | Measures trust towards the mHealth technologies. Total score ranges from 0 to 15. Higher scores indicate a more positive attitude or greater trust towards the mHealth agent or technology. | post-intervention (1-month after baseline) |
| D001523 |
| Mental Disorders |