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Active, Not Recruiting

NCT Number: NCT06593262

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, the Chinese University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Insomnia Severity Index

    Time frame: 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 severity of insomnia symptoms

Secondary outcomes

  1. sleep onset latency (SOL)

    Time frame: 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)

    7-day sleep diary

  2. wake after sleep onset (WASO)

    Time frame: 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)

    7-day sleep diary

  3. sleep efficiency (SE)

    Time frame: 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)

    7-day sleep diary

  4. Total sleep time (TST)

    Time frame: 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)

    7-day sleep diary

  5. The Pre-Sleep Arousal Scale

    Time frame: 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)

    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.

  6. The Cognitive Failures Questionnaire

    Time frame: 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)

    self-reported failures in perception, memory, and motor function Total score ranges from 0 to 100. Higher scores indicate more self-reported cognitive lapses.

  7. Ford Insomnia Response to Stress Test

    Time frame: 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)

    personal vulnerability to stress-related insomnia Total score ranges from 9 to 36. Higher scores suggest a greater likelihood of stress-induced insomnia.

  8. reduced Horne and Östberg Morningness and Eveningness Questionnaire

    Time frame: 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)

    Chronotype preference. Total score ranges from 4 to 25. Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype.

  9. The Dysfunctional Beliefs and Attitudes about Sleep Scale

    Time frame: 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)

    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.

  10. Patient Health Questionnaire-9

    Time frame: 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 severity of depressive symptoms. Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms.

  11. General Anxiety Disorder-7

    Time frame: 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 severity of anxiety symptoms. Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms

  12. The Sleep Hygiene Index

    Time frame: 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 practice of sleep hygiene behaviors. Total score ranges from 0 to 52. Higher scores reflect poorer sleep hygiene practices.

  13. The Charlotte Attitudes Towards Sleep Scale

    Time frame: 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)

    Perception and attitude towards sleep in youths. Total averaged score ranges from 1 to 7. Higher scores denote more positive attitudes about sleep.

  14. The Multidimensional Fatigue Inventory

    Time frame: 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)

    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.

Other outcomes

  1. Treatment Satisfaction Scale

    Time frame: post-intervention (1-month after baseline)

    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.

  2. Treatment Component Adherence

    Time frame: post-intervention (1-month after baseline)

    Treatment Component Adherence Scale. 26 single-item, each item has a scoring between 1 to 5.

  3. Acceptability E-scale questionnaire

    Time frame: post-intervention (1-month after baseline)

    Measures the digital program was acceptable or not. Total scores range from 6 to 30. The higher the score means a more positive evaluation.

  4. The Embodied Conversational Agents Trust Questionnaire

    Time frame: post-intervention (1-month after baseline)

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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