Digital Cognitive Behavioral Therapy for Insomnia in China

NCT ID: NCT05416346

Last Updated: 2022-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2021-06-12

Brief Summary

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Digital cognitive behavioral therapy for insomnia (dCBT-i) is found to be effective but is rarely used in China. Hence, the investigators developed an automated Chinese dCBT-i program and examined its feasibility, acceptability, and preliminary effectiveness in individuals with insomnia symptoms.

Detailed Description

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Conditions

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Primary Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dCBT-i

The dCBT-i group received the whole intervention

Group Type EXPERIMENTAL

Digital Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Cognitive behavioral therapy for insomnia (CBT-i) has been showed to be effective in reducing insomnia symptoms and insomnia-related symptoms, including sleepiness, dysfunctional beliefs and attitudes about sleep, anxiety and depressive symptoms

Sleep Hygiene Education (SHE)

The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.

Group Type ACTIVE_COMPARATOR

Digital Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Cognitive behavioral therapy for insomnia (CBT-i) has been showed to be effective in reducing insomnia symptoms and insomnia-related symptoms, including sleepiness, dysfunctional beliefs and attitudes about sleep, anxiety and depressive symptoms

Sleep Hygiene Education (SHE)

Intervention Type BEHAVIORAL

The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.

Interventions

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Digital Cognitive Behavioral Therapy

Cognitive behavioral therapy for insomnia (CBT-i) has been showed to be effective in reducing insomnia symptoms and insomnia-related symptoms, including sleepiness, dysfunctional beliefs and attitudes about sleep, anxiety and depressive symptoms

Intervention Type BEHAVIORAL

Sleep Hygiene Education (SHE)

The SHE group received sleep hygiene education delivered in text form, and the same intervention as the dCBT-i group did after four weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* were aged 18 or older;
* had a positive screening result for chronic insomnia, i.e., a score of 16 or lower on the Sleep Condition Indicator (SCI);
* had stable access to the internet via a smartphone.

Exclusion Criteria

* additional sleeping conditions except for insomnia (such as restless legs syndrome and sleep apnea);
* psychosis or mania;
* serious physical health concerns necessitating surgery or with prognosis \<6 months;
* undergoing medical or psychological treatment for insomnia with a health professional;
* habitual night shift, evening, or rotating shift-workers.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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dCBT-i-Chinese

Identifier Type: -

Identifier Source: org_study_id

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