Clinical trial NCT05551806: Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy in Reducing Insomnia Among Adult Population
Official title: Effectiveness of Internet-based Self-help Cognitive Behavioural Therapy (CBT-I) in Reducing Insomnia Symptoms Among the Adult Population: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Cognitive Behavioural Therapy
Lead sponsor: Education University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Baptist Oi Kwan Social Service
First posted: 2022-09-23
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary outcomes:
measure: Change from Baseline Assessment in General Sleep Disturbances on the Pittsburgh Sleep Quality Index (PSQI) at Post-Intervention Assessment and Follow-up Assessment
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: Change from Baseline Assessment in Daily Sleep-Wake Schedule on the 7-Day Consensus Sleep Diary at Post-Intervention Assessment and Follow-up Assessment
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: 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
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: Change from Baseline Assessment in Sleep Habits on the Sleep Hygiene Practice Scale (SHPS) at Post-Intervention Assessment and Follow-up Assessment
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: 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
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: 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
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: 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
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: 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
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: 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
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: 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
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: Change from Baseline Assessment in Expectation toward Intervention on the Credibility of Treatment Rating Scale (CTRS) at Post-Intervention Assessment and Follow-up Assessment
timeFrame: Before intervention, Immediately after intervention, and 4 weeks after intervention
measure: Insomnia Treatment Acceptability assessed the Insomnia Treatment Acceptability Scale (ITAS) at the Interview after Post-Intervention Assessment
timeFrame: Immediately after Post-Intervention Assessment
measure: Treatment Adherence at the Interview after Post-Intervention Assessment
timeFrame: Immediately after Post-Intervention Assessment
measure: Treatment Satisfaction at the Interview after Post-Intervention Assessment
timeFrame: Immediately after Post-Intervention Assessment
measure: Treatment Satisfaction in internet (Acceptability of the Internet for delivering CBT) at the Interview after Post-Intervention Assessment
timeFrame: Immediately after Post-Intervention Assessment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Baptist Oi Kwan Social Service
city: Hong Kong
country: Hong Kong
facility: The Education University of Hong Kong
Study officials:
affiliation: The Education University of Hong Kong
name: Kevin, Ka Shing CHAN
role: PRINCIPAL_INVESTIGATOR
References: