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Completed

NCT Number: NCT05747963

Software-delivered CBT-I for Insomnia Disorder

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Generalized Anxiety Disorder Scale-7 (GAD-7) scores ≥ 15;
  • Patients Health Questionnaire-9 (PHQ-9) scores ≥ 20;
  • Current thoughts of suicide or self-injury (defined as PHQ-9 9th item score ≥ 1);
  • 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);
  • 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.
  • Alcohol or drug abusers (other than nicotine dependence) in the past year;
  • Pregnant or lactating women;
  • Undergoing systematic psychotherapy within the past 3 months;
  • Undergoing other cognitive behavioral therapy for sleep disorders;
  • Unstable usage of medication regimens that affect sleep (changes in type, dosage and method of use within the past 1 month);
  • Night shift workers, travelers across time zones;
  • Subjects who have not responded to previous CBT-I;
  • Other conditions deemed unsuitable for clinical trials by the investigator.

Treatment and study plan

software-delivered CBT-I

Device

The automated software called 'resleep' incorporates all core elements of CBT-I: sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene and education, tailoring content based on each participant's reported baseline sleep function and sleep progress. The 6-week treatment includes 42 times of intervention.

online PE

Other

Subjects in the control group will receive non-tailored information about insomnia and sleep health education content using the Wechat Official Account.

Primary outcomes

  1. The Change of Insomnia Severity from Baseline to Follow-up

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    The insomnia severity is assessed with the Insomnia Severity Index (ISI), a 7-item questionnaire well validated in insomnia research in multiple patient populations. The change of ISI scores from baseline to follow-up is the primary outcome.

Secondary outcomes

  1. Insomnia Remission

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    Insomnia remission was evaluated by a masked assessor using a semi-structured interview.

  2. Insomnia Treatment Response

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    Insomnia treatment response was defined by a decrease in ISI by at least 8 points.

  3. Sleep Parameters Assessed by Sleep Diary

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    Sleep diaries related parameters include time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency.

  4. Sleep Quality

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    Pittsburgh Sleep Quality Index (PSQI) is used to assess overall sleep quality.

  5. Depression

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    Patient Health Questionnaire-9 (PHQ-9) is used to evaluate the severity of depression.

  6. Anxiety

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    Generalized Anxiety Disorder Scale-7 (GAD-7) is used to evaluate the severity of anxiety.

  7. Life Quality

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    WHOQOL-BREF is used to evaluate the life quality.

Other outcomes

  1. Adverse Events

    Time frame: Baseline, post-intervention, follow-up (3 months after post-intervention)

    Adverse events will be recorded throughout this trial for evaluating the safety of software.

Sponsors and collaborators

Lead sponsor

Peking University Sixth Hospital

Other

Collaborators

  • Peking University First Hospital
  • Shenzhen Kangning Hospital
  • Shenzhen Zeen Health Technology Co., Ltd.
  • Sichuan Provincial People's Hospital
  • The Second Affiliated Hospital of AFMU

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2023
Registry last updated
Aug 6, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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