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

NCT05551806 | Completed

• 1 other identifier: 2021-2022-0340
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

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.

Conditions

Insomnia

Keywords

Cognitive Behavioural Therapy

Outcome Measures

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

  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 Outcomes (15)

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

  Before intervention, Immediately after intervention, and 4 weeks after intervention

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

  Before intervention, Immediately after intervention, and 4 weeks after intervention

• 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

  Before intervention, Immediately after intervention, and 4 weeks after intervention

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

  Before intervention, Immediately after intervention, and 4 weeks after intervention

• 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

  Before intervention, Immediately after intervention, and 4 weeks after intervention

Study Arms (2)

CBT-I group

EXPERIMENTAL

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.

Behavioral: Internet-based self-help cognitive behavioural therapy

Waitlist control group

NO INTERVENTION

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.

Interventions

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.

CBT-I group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Education University of Hong Kong: lead
• Baptist Oi Kwan Social Service: collaborator

Study Sites (2)

Baptist Oi Kwan Social Service

Hong Kong, 999077, Hong Kong

Location

The Education University of Hong Kong

Hong Kong, 999077, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kevin, Ka Shing CHAN

  The Education University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of Department of Psychology

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 23, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)