search
Back to results

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

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Internet-based self-help cognitive behavioural therapy
Sponsored by
Education University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Cognitive Behavioural Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Baptist Oi Kwan Social ServiceRecruiting
  • The Education University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT-I group

Waitlist control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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).
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).

Full Information

First Posted
September 1, 2022
Last Updated
September 19, 2022
Sponsor
Education University of Hong Kong
Collaborators
Baptist Oi Kwan Social Service
search

1. Study Identification

Unique Protocol Identification Number
NCT05551806
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Education University of Hong Kong
Collaborators
Baptist Oi Kwan Social Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Cognitive Behavioural Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT-I group
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based self-help cognitive behavioural therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Assessment in the Severity of Sleep Problem on the Insomnia Severity Index (ISI) at Post-Intervention Assessment and Follow-up Assessment
Description
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).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Secondary Outcome Measure Information:
Title
Change from Baseline Assessment in General Sleep Disturbances on the Pittsburgh Sleep Quality Index (PSQI) at Post-Intervention Assessment and Follow-up Assessment
Description
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).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
Change from Baseline Assessment in Daily Sleep-Wake Schedule on the 7-Day Consensus Sleep Diary at Post-Intervention Assessment and Follow-up Assessment
Description
The 7-day consensus sleep diary will calculate the change of participants' sleep parameters from the diary data.
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
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
Description
The PSAS assesses the change in a 5-point Likert scale, ranging from 1 (not at all) to 5 (extremely).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
Change from Baseline Assessment in Sleep Habits on the Sleep Hygiene Practice Scale (SHPS) at Post-Intervention Assessment and Follow-up Assessment
Description
The SHPS assesses the change in a 6-point Likert scale, ranging from 1 (never) to 6 (always).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
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
Description
The DBAS assesses the change in a 10-point Likert scale, ranging from 0 (strongly disagree) to 10 (strongly agree).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
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
Description
The WHO-5 assesses the change in a 6-point Likert scale, ranging from 1 (never) to 6 (all of the time).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
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
Description
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).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
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
Description
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).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
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
Description
The WSAS assesses the change in a 9-point Likert scale, ranging from 1 (not at all) to 9 (very severely).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
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
Description
The MIC-SR assesses the change in a 4-point Likert scale, ranging from 1 (never) to 4 (almost daily).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
Change from Baseline Assessment in Expectation toward Intervention on the Credibility of Treatment Rating Scale (CTRS) at Post-Intervention Assessment and Follow-up Assessment
Description
The CTRS assesses the change in a 6-point Likert scale, ranging from 1 (not at all confident) to 6 (very confident).
Time Frame
Before intervention, Immediately after intervention, and 4 weeks after intervention
Title
Insomnia Treatment Acceptability assessed the Insomnia Treatment Acceptability Scale (ITAS) at the Interview after Post-Intervention Assessment
Description
The ITAS assesses the insomnia treatment acceptability in a 10-point Likert scale, ranging from 1 (not at all acceptable) to 10 (very acceptable).
Time Frame
Immediately after Post-Intervention Assessment
Title
Treatment Adherence at the Interview after Post-Intervention Assessment
Description
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.
Time Frame
Immediately after Post-Intervention Assessment
Title
Treatment Satisfaction at the Interview after Post-Intervention Assessment
Description
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).
Time Frame
Immediately after Post-Intervention Assessment
Title
Treatment Satisfaction in internet (Acceptability of the Internet for delivering CBT) at the Interview after Post-Intervention Assessment
Description
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).
Time Frame
Immediately after Post-Intervention Assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin, Ka Shing CHAN
Phone
(852) 2948 8747
Email
kkschan@eduhk.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin, Ka Shing CHAN
Organizational Affiliation
The Education University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Oi Kwan Social Service
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scarlet, Fung Oi POON
Facility Name
The Education University of Hong Kong
City
Hong Kong
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin, Ka Shing CHAN
First Name & Middle Initial & Last Name & Degree
Ian, Chun Bun LAM

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs