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

E

Education University of Hong Kong

Status

Completed

Conditions

Insomnia

Treatments

Behavioral: Internet-based self-help cognitive behavioural therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05551806
2021-2022-0340

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 2 patient groups

CBT-I group
Experimental group
Description:
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.
Treatment:
Behavioral: Internet-based self-help cognitive behavioural therapy
Waitlist control group
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

2

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Central trial contact

Kevin, Ka Shing CHAN

Data sourced from clinicaltrials.gov

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