Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)

Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) With Artificial Intelligence Chatbot for Youth With Insomnia: An Assessor-blind, Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: app-based digital cognitive behavioral therapy for insomnia with AI chatbot; Behavioral: app-based digital cognitive behavioral therapy for insomnia without AI chatbot

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Psychiatry, the Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: app-based digital cognitive behavioral therapy for insomnia with AI chatbot	Behavioral: app-based digital cognitive behavioral therapy for insomnia with AI chatbot; digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and patient-centered conversational agents
Active Comparator: app-based digital cognitive behavioral therapy for insomnia without AI chatbot	Behavioral: app-based digital cognitive behavioral therapy for insomnia without AI chatbot; digital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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)

Other Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 14106223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No