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Completed

NCT Number: NCT05416346

Digital Cognitive Behavioral Therapy for Insomnia in China

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.

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Cognitive Behavioral Therapy

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)

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.

Primary outcomes

  1. sleep diary

    Time frame: week 4

    recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality

  2. Sleep Condition Indicator-8

    Time frame: week 4

    Sleep Condition Indicator-8 is an 8-item scale validated against Diagnostic and Statistical Manual-5 criteria, concerning sleep quality and daytime personal functioning. It scores between 0 to 32, with higher scores meaning better sleep.

Secondary outcomes

  1. the Insomnia Severity Index 7-item version

    Time frame: week 4

    It scores between 0 to 28, with higher scores meaning more severe insomnia.

  2. the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item version

    Time frame: week 4

    It scores between 16 to 80, with higher scores meaning more dysfunctional beliefs.

  3. the Epworth Sleepiness Scale

    Time frame: week 4

    It scores between 0 to 24, with higher scores meaning greater sleepiness.

  4. the Patient Health Questionnaire 9-item version

    Time frame: week 4

    It scores between 0 to 27, with higher scores meaning higher depressive symptoms.

  5. the Generalized Anxiety Disorder 7-item version

    Time frame: week 4

    It scores between 0 to 21, with higher scores meaning higher anxious symptoms.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

The Feasibility and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in China: A Pilot Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 13, 2022
Registry last updated
Jun 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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