A Stepped Care Model to Deliver CBT-I in Community

November 27, 2023 updated by: Professor Wing Yun Kwok, Chinese University of Hong Kong

Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia in Adults, a Pragmatic Stepped-wedge Cluster Randomized Trial

Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due to limited accessibility, lack of trained sleep therapists, time costing and geographical limitations. To increase CBT-I accessibility, different formats of CBT-I have been proposed. Empirical evidence including ours consistently suggested that self-help digital CBT-I is effective in improving sleep while its augmentation with a guided approach could further enhance the treatment gain. Previous evidence has suggested that although self-help CBT-I could lead to positive outcomes, the drop out rate is quite high and maybe less effective for patients with comorbidity or high level of distress.

Thus, a stepped-care approach to CBT-I that utilizes online self help and therapist-guided modes of delivery might be a potential way to facilitate efficient dissemination of effective insomnia treatment resources. The effectiveness of the stepped care model will be evaluated in a real world setting using stepped-wedge cluster randomized controlled design. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a eqaully spaced time periods.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This interventional study will be a multicenter, assessor-blinded, pragmatic stepped-wedge cluster randomized controlled trial. A total of 18 districts will be included in the study and the randomization will be carried out based on the districts. The stepped-care CBT-I intervention will be sequentially rolled out to the 4-6 districts per step according to a computer-generated random number while the remaining clusters will continue to stay unexposed to the CBT-I intervention over the control period. Therefore after 4-step exposure, all clusters will receive the stepped-care CBT-I intervention. A total of 3 follow-up assessments (post intervention, 3-month and 12-month follow up) will be conducted to assess the effectiveness and long-term effects of the stepped care model.

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
    • New Territories
      • Sha Tin, New Territories, Hong Kong
        • Recruiting
        • Department of Psychiatry, the Chinese University of Hong Kong
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Chinese adults aged 18-70 years old,
  2. The score of Insomnia Severity Index ≥ 10.

Exclusion Criteria:

  1. present with psychotic disorders such as bipolar disorder and schizophrenia,
  2. present with severe depression or suicidal ideation,
  3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).
  4. unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stepped-care CBT-I group

A total of 3 steps of CBT-I intervention will be provided, with the objectives to increase the awareness of sleep health, increase sleep literacy, establish good sleep hygiene and treat insomnia.

Step 1: self-help digital CBT-I program; Step 2: guided CBT-I program; Step 3: individualized consultation.
Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)
CBT-I intervention will be provided to participants once their districts are exposed.
No Intervention: Control group
Participants in the control group remain unexposed to the stepped-care CBT-I intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia severity index
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
The primary outcome will be the perceived insomnia severity measured by Insomnia Severity Index (ISI).
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of depression
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Patient Health Questionnaire-9 (PHQ-9) will be used to measure the severity of depression.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Severity of anxiety
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
General Anxiety Disorder-7 (GAD-7) will be used to measure the severity of anxiety.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Health-related quality of life
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
The health-related quality of life (HRQoL) will be measured by the EuroQol-5D (EQ).
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Chronic insomnia diagnosis
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
A checklist based on Diagnostic and statistical manual of mental disorders will be implemented to measure the incidence of chronic insomnia.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Medication usage
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
A checklist will be used to measure the subject's medication usage change over the past 3 months.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Clinical global impression
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Clinical Global Impression (CGI) will be used to assess the overall improvement or change in a patient's condition over time.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Patient-report clinical global impression
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
A single-item CGI will be used to ask the participant whether they experience sleep improvement or change over the past week or not.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Sleep duration
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Two self-report questions will be used to record the sleep duration during weekdays and weekends of the participants.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Subjective sleep as measured by sleep diary
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Self-report sleep diary will be used to record subjective sleep of the participants including total time in bed, sleep onset latency, total sleep duration, sleep efficiency and wake after sleep onset.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Healthcare resource use
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
The use and expense of sleep-promoting medication, psychotherapy, and other complementary treatments for sleep improvement over the past 3 months will be collected from individual participants using a self-developed questionnaire, with a focus on their healthcare resource utilization.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
Work and social functioning
Time Frame: Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up
A 5-item questionnaire developed from Work and Social Adjustment Scale (WSAS) will be used to measure the daytime functioning of the participants such as ability to work, home management, social and private leisure activities, and close relationship maintenance.
Post-intervention (ranging from 8 weeks to 24 weeks, depending on the treatment level), 3-month post-intervention and 12-month post-intervention follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Yun Kwok Wing, FRCPsych, Department of Psychiatry, the Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2023

Primary Completion (Estimated)

January 22, 2025

Study Completion (Estimated)

April 22, 2025

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230816

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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