A Stepped Care Model to Deliver CBT-I in Community

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-23

Study Completion Date

2026-04-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Pragmatic stepped wedge design - over 4 months, 18 sites enter trial at 1 month intervals. 2

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive behavioral therapy for insomnia (CBT-I)

Intervention Type BEHAVIORAL

CBT-I intervention will be provided to participants once their districts are exposed.

Control group

Participants in the control group remain unexposed to the stepped-care CBT-I intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive behavioral therapy for insomnia (CBT-I)

CBT-I intervention will be provided to participants once their districts are exposed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes