---
title: Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I)
nct_id: NCT06593262
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: Chinese University of Hong Kong
study_type: INTERVENTIONAL
primary_condition: Insomnia
countries: Hong Kong
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06593262.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06593262"
ct_last_update_post_date: 2026-03-18
last_seen_at: "2026-05-12T06:14:35.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT06593262](https://clinicaltrials.gov/study/NCT06593262)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 168
- **Lead Sponsor:** Chinese University of Hong Kong
- **Conditions:** Insomnia
- **Start Date:** 2024-07-26
- **Completion Date:** 2026-08
- **CT.gov Last Update:** 2026-03-18

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 25 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **app-based digital cognitive behavioral therapy for insomnia with AI chatbot** (EXPERIMENTAL)
- **app-based digital cognitive behavioral therapy for insomnia without AI chatbot** (ACTIVE_COMPARATOR)

## 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 without AI chatbot** (BEHAVIORAL) — digital cognitive behavioral therapy for insomnia without two-way interactive, intelligent, and patient-centered conversational agents

## Primary Outcomes

- **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

- **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))_
- **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))_
- **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))_
- **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))_
- **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))_
- **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))_
- **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))_
- **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))_
- **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))_
- **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))_
- **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 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 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))_
- **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))_

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of psychiatry, the chinese university of hong kong|hong kong||hong kong` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06593262.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06593262*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*