Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05551806
Other study ID # 2021-2022-0340
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2024
Source Education University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
Internet-based self-help cognitive behavioural therapy
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.

Locations

Country Name City State
Hong Kong Baptist Oi Kwan Social Service Hong Kong
Hong Kong The Education University of Hong Kong Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Education University of Hong Kong Baptist Oi Kwan Social Service

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment 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). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary Change from Baseline Assessment in General Sleep Disturbances on the Pittsburgh Sleep Quality Index (PSQI) at Post-Intervention Assessment and Follow-up Assessment 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). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary Change from Baseline Assessment in Daily Sleep-Wake Schedule on the 7-Day Consensus Sleep Diary at Post-Intervention Assessment and Follow-up Assessment The 7-day consensus sleep diary will calculate the change of participants' sleep parameters from the diary data. Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary 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 The PSAS assesses the change in a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary Change from Baseline Assessment in Sleep Habits on the Sleep Hygiene Practice Scale (SHPS) at Post-Intervention Assessment and Follow-up Assessment The SHPS assesses the change in a 6-point Likert scale, ranging from 1 (never) to 6 (always). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary 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 The DBAS assesses the change in a 10-point Likert scale, ranging from 0 (strongly disagree) to 10 (strongly agree). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary 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 The WHO-5 assesses the change in a 6-point Likert scale, ranging from 1 (never) to 6 (all of the time). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary 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 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). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary 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 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). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary 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 The WSAS assesses the change in a 9-point Likert scale, ranging from 1 (not at all) to 9 (very severely). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary 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 The MIC-SR assesses the change in a 4-point Likert scale, ranging from 1 (never) to 4 (almost daily). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary Change from Baseline Assessment in Expectation toward Intervention on the Credibility of Treatment Rating Scale (CTRS) at Post-Intervention Assessment and Follow-up Assessment The CTRS assesses the change in a 6-point Likert scale, ranging from 1 (not at all confident) to 6 (very confident). Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary Insomnia Treatment Acceptability assessed the Insomnia Treatment Acceptability Scale (ITAS) at the Interview 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). Immediately after Post-Intervention Assessment
Secondary Treatment Adherence at the Interview 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. Immediately after Post-Intervention Assessment
Secondary Treatment Satisfaction at the Interview 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). Immediately after Post-Intervention Assessment
Secondary Treatment Satisfaction in internet (Acceptability of the Internet for delivering CBT) at the Interview 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). Immediately after Post-Intervention Assessment
See also
  Status Clinical Trial Phase
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT05963542 - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia N/A
Completed NCT06339853 - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia N/A
Recruiting NCT04069247 - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia N/A
Completed NCT04493593 - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility N/A
Recruiting NCT06278077 - Neurexan - a Clinical Trial in Short-Term Insomnia Patients Phase 2
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT04661306 - The Better Sleep for Supporters With Insomnia Study N/A
Recruiting NCT06207279 - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting NCT06006299 - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC) N/A
Completed NCT03683381 - App-based Intervention for Treating Insomnia Among Patients With Epilepsy N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04035200 - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation Phase 2
Active, not recruiting NCT05027438 - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention N/A
Recruiting NCT06053840 - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia Phase 4
Not yet recruiting NCT06348082 - Project Women's Insomnia Sleep Health Equity Study (WISHES) N/A
Not yet recruiting NCT06363799 - Osteopathic Protocol for Insomnia in College Students N/A
Not yet recruiting NCT05991492 - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application N/A
Not yet recruiting NCT06025968 - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis N/A