Clinical trial NCT06593262: Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Insomnia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 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:
measure: sleep onset latency (SOL)
timeFrame: 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)
measure: wake after sleep onset (WASO)
timeFrame: 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)
measure: sleep efficiency (SE)
timeFrame: 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)
measure: Total sleep time (TST)
timeFrame: 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)
measure: The Pre-Sleep Arousal Scale
timeFrame: 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)
measure: The Cognitive Failures Questionnaire
timeFrame: 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)
measure: Ford Insomnia Response to Stress Test
timeFrame: 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)
measure: reduced Horne and Östberg Morningness and Eveningness Questionnaire
timeFrame: 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)
measure: The Dysfunctional Beliefs and Attitudes about Sleep Scale
timeFrame: 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)
measure: Patient Health Questionnaire-9
timeFrame: 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: General Anxiety Disorder-7
timeFrame: 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: The Sleep Hygiene Index
timeFrame: 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)
measure: The Charlotte Attitudes Towards Sleep Scale
timeFrame: 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)
measure: The Multidimensional Fatigue Inventory
timeFrame: 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:
measure: Treatment Satisfaction Scale
timeFrame: post-intervention (1-month after baseline)
measure: Treatment Component Adherence
timeFrame: post-intervention (1-month after baseline)
measure: Acceptability E-scale questionnaire
timeFrame: post-intervention (1-month after baseline)
measure: The Embodied Conversational Agents Trust Questionnaire
timeFrame: post-intervention (1-month after baseline)
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Psychiatry, the Chinese University of Hong Kong
Study officials:
References: