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

N/AActive Not RecruitingNCT06593262

Chinese University of Hong Kong168 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

168

Conditions

Insomnia

Interventions

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

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 chatbotBEHAVIORAL

digital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents

Eligibility

Sex: ALLMin age: 18 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry, the Chinese University of Hong Kong

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Insomnia Severity Index

the severity of insomnia symptoms

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)

Secondary Outcomes

sleep onset latency (SOL)

7-day sleep diary

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)

wake after sleep onset (WASO)

7-day sleep diary

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)

sleep efficiency (SE)

7-day sleep diary

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)

Total sleep time (TST)

7-day sleep diary

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 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.

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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.

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)

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.

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)

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.

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 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.

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)

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.

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

The Sleep Hygiene Index

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

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 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.

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 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.

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)