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

NCT06593262 | Active Not Recruiting DMC

• 1 other identifier: 14106223
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• sleep onset latency (SOL)

  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)

  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)

  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)

  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

  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 Outcomes (4)

• Treatment Satisfaction Scale

  post-intervention (1-month after baseline)

• Treatment Component Adherence

  post-intervention (1-month after baseline)

• Acceptability E-scale questionnaire

  post-intervention (1-month after baseline)

Study Arms (2)

app-based digital cognitive behavioral therapy for insomnia with AI chatbot

EXPERIMENTAL

Behavioral: app-based digital cognitive behavioral therapy for insomnia with AI chatbot

app-based digital cognitive behavioral therapy for insomnia without AI chatbot

ACTIVE COMPARATOR

Behavioral: app-based digital cognitive behavioral therapy for insomnia without AI chatbot

Interventions

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 with AI chatbot

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

app-based digital cognitive behavioral therapy for insomnia without AI chatbot

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, the Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: September 19, 2024
• Study Start: July 26, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

HK (1)