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NCT Number: NCT05551806

Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy in Reducing Insomnia Among Adult Population

This experimental study aims to develop an internet-based self-help cognitive behavioural therapy for insomnia that reduces insomnia symptoms and its associated adverse outcomes among people with sub-threshold insomnia symptoms. In particular, this study compares the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population.

The online CBT-I course will consist of an introductory module, followed by 6 weekly modules. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.

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Key information

Conditions

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

Baptist Oi Kwan Social Service, Hong Kong

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About this study

Although the Internet self-help CRT-I program have shown promising effect on dealing with insomnia symptoms, the effectiveness of internet self-help CBT-I in adults with sub-clinical insomnia symptoms in Hong Kong is under-studied. Therefore, the present study aimed to compare the efficacy of internet-delivered self-help CBT-I with the wait-list control group, in treating insomnia in a non-clinical population. We hypothesized that (1) participants who received CBT-I treatment would have improved insomnia symptoms after the intervention as compared with the wait-list controls; (2) participants from CBT-I would have better sleep hygiene, and less dysfunctional beliefs about sleep and pre-sleep arousal after the intervention as compared with the wait-list controls; (3) participants from CBT-I would have improved mental health, daytime functioning, quality of life, and general well-being after treatment, as compared with the wait-list controls.

The online CBT-I course will consist of an introductory module, followed by 6 weekly modules, incorporating the key CBT-I components, including sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Each module will consist of the main treatment component presented in written or video format, quiz, and homework. Materials will be presented in an interactive manner to facilitate engagement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hong Kong residents
  • Age ≥18 years
  • Insomnia Severity Index score > 7 and < 22
  • Being able to read Chinese
  • Have a computer, tablet and/or smartphone device with Internet access
  • have a regular email address
  • Willing to give informed consent and comply with the trial protocol

Exclusion criteria

  • Receiving psychological treatment at least once per month
  • Currently taking prescribed psychiatric drugs such as antidepressants, tranquilizers, and sleeping pills regularly
  • Carrying a diagnosis of psychosis or schizophrenia
  • Participating in any other academic studies or clinical trials related to insomnia
  • Having current suicidal plans or acts or having had suicidal plans or acts within the past 12 months
  • Shift workers

Treatment and study plan

Internet-based self-help cognitive behavioural therapy

Behavioral

The online CBT-I course will consist of an introductory module, followed by 6 weekly modules, incorporating the key CBT-I components, including sleep hygiene education, stimulus control, sleep restriction, relaxation training, and cognitive therapy.

Primary outcomes

  1. Change from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The ISI assesses the change in a 5-point Likert scale, ranging from 1 (none/ very dissatisfied/ not at all noticeable, worried & interfering) to 5 (very severe/ very satisfied/ very much noticeable, worried & interfering).

Secondary outcomes

  1. Change from Baseline Assessment in General Sleep Disturbances on the Pittsburgh Sleep Quality Index (PSQI) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The PSQI assesses the change in a 4-point Likert scale, ranging from 1 (not during the past month/ very good) to 4 (three or more times a week/ very poor).

  2. Change from Baseline Assessment in Daily Sleep-Wake Schedule on the 7-Day Consensus Sleep Diary at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The 7-day consensus sleep diary will calculate the change of participants' sleep parameters from the diary data.

  3. Change from Baseline Assessment in Cognitive and Somatic Manifestations of Arousal on the Pre-sleep Arousal Scale (PSAS) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The PSAS assesses the change in a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely).

  4. Change from Baseline Assessment in Sleep Habits on the Sleep Hygiene Practice Scale (SHPS) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The SHPS assesses the change in a 6-point Likert scale, ranging from 1 (never) to 6 (always).

  5. Change from Baseline Assessment in Sleep Related Cognition on the Dysfunctional Beliefs and Attitudes about Sleep (DBAS) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The DBAS assesses the change in a 10-point Likert scale, ranging from 0 (strongly disagree) to 10 (strongly agree).

  6. Change from Baseline Assessment in Psychological Wellbeing on the World Health Organisation-Five Well-Being Index (WHO-5) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The WHO-5 assesses the change in a 6-point Likert scale, ranging from 1 (never) to 6 (all of the time).

  7. Change from Baseline Assessment in Psychological Distress on the Short Form of the Depression, Anxiety, and Stress Scale (DASS-21) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The DASS-21 assesses the change in a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time).

  8. Change from Baseline Assessment in Quality of Life on the Twelve-Item Short-Form (SF-12) Health Survey at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The SF-12 assesses the change in a combination of 5-point and 3-point Likert scale, ranging respectively from 1 (poor/ never) to 5 (excellent/ very much), and 1 (never) to 3 (very much).

  9. Change from Baseline Assessment in Functional Impairment of Insomnia on the Work and Social Adjustment Scale (WSAS) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The WSAS assesses the change in a 9-point Likert scale, ranging from 1 (not at all) to 9 (very severely).

  10. Change from Baseline Assessment in Cognitive Failure on the Measure of Insight into Cognition-Self Report (MIC-SR) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The MIC-SR assesses the change in a 4-point Likert scale, ranging from 1 (never) to 4 (almost daily).

  11. Change from Baseline Assessment in Expectation toward Intervention on the Credibility of Treatment Rating Scale (CTRS) at Post-Intervention Assessment and Follow-up Assessment

    Time frame: Before intervention, Immediately after intervention, and 4 weeks after intervention

    The CTRS assesses the change in a 6-point Likert scale, ranging from 1 (not at all confident) to 6 (very confident).

  12. Insomnia Treatment Acceptability assessed the Insomnia Treatment Acceptability Scale (ITAS) at the Interview after Post-Intervention Assessment

    Time frame: Immediately after Post-Intervention Assessment

    The ITAS assesses the insomnia treatment acceptability in a 10-point Likert scale, ranging from 1 (not at all acceptable) to 10 (very acceptable).

  13. Treatment Adherence at the Interview after Post-Intervention Assessment

    Time frame: Immediately after Post-Intervention Assessment

    Participants report the number of sessions they had read, how long they had spent on the CBT program, and how far they had followed the instructions.

  14. Treatment Satisfaction at the Interview after Post-Intervention Assessment

    Time frame: Immediately after Post-Intervention Assessment

    Participants report on whether they like, found it useful, and improvement of the intervention in a 10-point Likert scale, ranging from 0 (not at all suitable) to 10 (very suitable).

  15. Treatment Satisfaction in internet (Acceptability of the Internet for delivering CBT) at the Interview after Post-Intervention Assessment

    Time frame: Immediately after Post-Intervention Assessment

    Participants report on how suitable, how convenient, how much they liked, and how worried they were about their privacy in a 10-point Likert scale, ranging from 0 (not at all suitable) to 10 (very suitable).

Sponsors and collaborators

Lead sponsor

Education University of Hong Kong

Other

Collaborators

  • Baptist Oi Kwan Social Service

Registry information

Official study title

Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy (CBT-I) in Reducing Insomnia Symptoms Among the Adult Population: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
Feb 28, 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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