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CompletedNo phase

Software-delivered CBT-I for Insomnia Disorder

Key facts

Who runs it
Peking University Sixth Hospital
Where
China5 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
236 people enrolled
Started
21 Mar 2023
Ended
21 Mar 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • software-delivered CBT-I
  • online PE
Record updated
6 August 2024

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • Aged ≥18 years old, no gender limitation
  • Own a mobile-phone, access the Internet, and be skilled in using software
  • Meet the diagnostic criteria of insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5)
  • Insomnia symptoms appear at least 3 nights per week and last for at least 3 months
  • ISI scores ≥ 12
  • Volunteer to participate in this experiment and sign a written informed consent

Who cannot take part

  • Alcohol or drug abusers (other than nicotine dependence) in the past year
  • Unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month)
  • Subjects who have not responded to previous CBT-I
  • Generalized Anxiety Disorder Scale-7 (GAD-7) scores ≥ 15
  • Confirmed physical diseases that may affect sleep, such as congestive heart failure, chronic obstructive pulmonary disease acute phase, cardiovascular and cerebrovascular disease acute phase, etc
  • Current diagnosed neurological or mental illness (major depressive disorder, bipolar disorder, epilepsy, schizophrenia, etc.) that may affect sleep
  • Diagnoses of other untreated sleep disorders, such as obstructive sleep apnea, restless leg syndrome (RLS)
  • Undergoing other cognitive behavioral therapy for sleep disorders
  • Other conditions deemed unsuitable for clinical trials by the investigator
  • Patients Health Questionnaire-9 (PHQ-9) scores ≥ 20
  • Current thoughts of suicide or self-injury (defined as PHQ-9 9th item score ≥ 1)
  • Usual bedtime (when the subject attempts to fall asleep) is earlier than 8 p.m. or later than 2 a.m., or usual waking (arising) time is earlier than 4 a.m. or later than 10 a.m
  • Pregnant or lactating women
  • Undergoing systematic psychotherapy within the past 3 months
  • Night shift workers, travelers across time zones

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The goal of this prospective multicenter clinical trial is to evaluate the efficacy and safety of software-delivered cognitive behavioral therapy for insomnia (CBT-I) in Chinese patients with insomnia disorder (ID). The main questions it aims to answer are: (1) whether the software-delivered CBT-I is more effective than an online patient education (online-PE) at improving insomnia. (2) whether the software-delivered CBT-I is safe for treatment of insomnia symptoms.

Read full original descriptionShow less

Participants will be randomized to receive (1) a software-delivered CBT-I using automated software called 'resleep' (one kind of digital device expected to treat insomnia targeted for Chinese patients); (2) online patient education (online-PE) about sleep.

Researchers will compare the efficacy of a software-delivered CBT-I program and an online sleep education control at improving insomnia symptoms and other psychological outcomes.

The 2 groups in the trial

  • software-delivered CBT-ITreatment being tested

    Subjects in intervention group will receive a digital CBT-I for 6 weeks. The automated software incorporates all core elements of CBT-I, tailoring content based on each participant's reported baseline sleep function and sleep progress.

  • online PEExisting treatment, for comparison

    Subjects in control group will receive information about insomnia and sleep health education content.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective, Multicenter, Randomized Clinical Trial for Evaluating the Safety and Efficacy of Software-delivered Cognitive Behavioral Therapy for Insomnia in Patients With Insomnia Disorder.
Record updated
6 August 2024