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

NCT ID: NCT05551806

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-I group

Participants in the CBT-I condition start the 6-week CBT-I immediately after randomization, complete the post-intervention assessment right after they finish the treatment, and complete the follow-up assessment 4 weeks after the post-intervention assessment. They will be invited to participate in an interview after completing the post-intervention assessment.

Group Type: EXPERIMENTAL

Internet-based self-help cognitive behavioural therapy

Intervention Type: 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.

Waitlist control group

Participants in the waitlist control group will wait for 6 weeks without the CBT-I intervention and then complete the post-intervention assessment; while waiting for 4 more weeks and then completing the follow-up assessment. The waitlist control participants will start CBT-I (equivalent to that of the CBT-I group) immediately after completing the follow-up assessment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baptist Oi Kwan Social Service

OTHER

Sponsor Role: collaborator

Education University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CHAN Ka Shing Kevin

Associate Professor, Head of Department of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin, Ka Shing CHAN

Role: PRINCIPAL_INVESTIGATOR

The Education University of Hong Kong

Locations

Baptist Oi Kwan Social Service

Hong Kong, , Hong Kong

The Education University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2021-2022-0340

Identifier Type: -

Identifier Source: org_study_id