Prevention of Insomnia Using a Stepped Care Model in Adults

NCT06156293 | Recruiting

• 1 other identifier: 20230816.02
• Study Type: interventional
• Target: 1,016
• Locations: 1 country
• Sites: 1

Brief Summary

Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Our previous study has shown that insomnia can be prevented through a brief cognitive behavioral prevention program in adolescents. However, there is very limited data in the adult population. Current study aims to evaluate a digital sleep-focused platform which consists of different intervention plan according to user's insomnia severity level and employed a stepped care model. Thus, the effectiveness of the stepped care model will be evaluated in a real world setting using stepped wedge cluster randomized controlled design to evaluate potential preventive effect on adults who only with mild insomnia symptoms. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a equally spaced time periods. The primary aim of this study is to evaluate the effects of a stepped-care CBT-I model in improving sleep and prevent the incidence of insomnia among participants with mild insomnia.

Conditions

Sleep Disturbance

Keywords

Sleep Disturbance; Stepped care model; Stepped wedge cluster randomized trial; Prevention program

Outcome Measures

Primary Outcomes (1)

• Insomnia severity index

  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 postintervention and 12-month post-intervention follow up

Secondary Outcomes (11)

• 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

  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

  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

  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

  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

Study Arms (2)

Stepped-care CBT-I group

EXPERIMENTAL

A total of 3 steps of sleep focused 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 sleep focused program; Step 2: guided intervention; Step 3: individualized consultation.

Behavioral: Cognitive behavioral prevention program for insomnia (CBP-I)

Control group

NO INTERVENTION

Participants in the control group remain unexposed to the stepped-care sleep-focused intervention.

Interventions

Cognitive behavioral prevention program for insomnia (CBP-I) BEHAVIORAL

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

Stepped-care CBT-I group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese adults aged 18-70 years old,
• The score of Insomnia Severity Index \< 10.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, the Chinese University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Parasomnias

Interventions

Annexin A5

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Annexins; Calcium-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Yun Kwok Wing, FRCPsych

  Department of Psychiatry, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Ngan Yin Chan

CONTACT

39710550; rachel.chan@cuhk.edu.hk

Jucheng Yu, PhD

CONTACT

39710550; juchengyu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (1)