Brief Behavioral Intervention to Maintain Sleep Regularity in Young Adults Over the Christmas Break

NCT07056179 | Not Yet Recruiting

• 2 other identifiers: 20250606_RESTREC/24-25/0554
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

This study will employ a randomized controlled trial design to investigate the effects of a brief behavioral intervention that includes (1) self-recording of a regularity-focused sleep diary, (2) 10 strategies for maintaining sleep regularity, and (3) a sleep education information sheet on the maintenance of sleep regularity in young adults during the Christmas break.

Conditions

Sleep

Keywords

sleep regularity; brief behavioral intervention; young adults

Outcome Measures

Primary Outcomes (1)

• Sleep regularity

  Sleep regularity will be measured by the validated Chinese version of sleep regularity questionnaire (SRQ), which shows excellent reliability and validity. SRQ consists of six items focusing on two dimensions, circadian regularity and sleep continuity regularity. Each item is rated on a scale ranging from 0 (not at all) to 4 (very much) in terms of the degree to which they agreed with each statement, with higher scores indicating higher sleep regularity.

  From baseline assessment to the end of intervention at 3 weeks

Secondary Outcomes (3)

• Severity of depression

  From baseline assessment to the end of intervention at 3 weeks

• Severity of anxiety

  From baseline assessment to the end of intervention at 3 weeks

• Work and social functioning

  From baseline assessment to the end of intervention at 3 weeks

Study Arms (2)

Brief behavioural intervention group

EXPERIMENTAL

Participants will receive a brief behavioral intervention comprising a regularity-focused sleep diary, 10 tips for maintaining sleep regularity, and a sleep education information sheet. The regularity-focused sleep diary is designed to emphasize in-bed and out-of-bed times, drawing participants' attention to their sleep regularity. Participants will be provided with a yellow marker to highlight their sleep periods. The 10 tips for maintaining sleep regularity include establishing a consistent out-of-bed time, using natural light to regulate the circadian clock, adjusting mealtimes, etc. The sleep education sheet contains information on reducing caffeine intake in the afternoon, limiting screen time before bed, etc.

Behavioral: Brief behavioural intervention

Health education control group

PLACEBO COMPARATOR

Participants will receive general health information without specific emphasis on sleep, such as weight control, smoking cessation, etc.

Behavioral: Health education

Interventions

Brief behavioural intervention BEHAVIORAL

Participants will receive a brief behavioural intervention comprising a regularity-focused sleep diary, 10 tips for maintaining sleep regularity, and a sleep education information sheet. The regularity-focused sleep diary is designed to emphasize in-bed and out-of-bed times, drawing participants' attention to their sleep regularity. Participants will be provided with a yellow marker to highlight their sleep periods. The 10 tips for maintaining sleep regularity include establishing a consistent out-of-bed time, using natural light to regulate the circadian clock, adjusting mealtimes, etc. The sleep education sheet contains information on reducing caffeine intake in the afternoon, limiting screen time before bed, etc.

Brief behavioural intervention group

Health education BEHAVIORAL

Participants will receive general health information without specific emphasis on sleep, such as weight control, smoking cessation, etc.

Health education control group

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young adults aged 18-24 years;
• Will stay in Hong Kong during the study period;
• Will not engage in any activities that require a fixed sleep or wake-up time (e.g., work or study during the holiday period) as these activities could regularize the sleep schedule and potentially contaminate the results.

You may not qualify if:

• Have been in a different time zone within two weeks before the baseline assessment;
• Diagnosed with circadian rhythm disorders such as delayed sleep-wake phase disorder (DSWD), advanced sleep-wake phase disorder (ASWD), irregular sleep-wake rhythm disorder (ISWRD), and non-24-hour sleep-wake rhythm disorder (N24WSD);
• Diagnosed with sleep disorders that directly/indirectly interfere with sleep regularity (e.g., insomnia, sleep apnea);
• Use of medications or treatment that may influence sleep regularity (e.g., hypnotics, antidepressants);
• Diagnosed with serious physical or mental diseases such as cancer, end-stage liver or kidney diseases, schizophrenia, and psychosis.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• The University of Hong Kong: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Hong Kong Baptist University

Kowloon City, Kowloon Tong, Hong Kong

Location

Study Officials

• Danny YU, PhD

  Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danny YU, PhD

CONTACT

852-34115309; dannyu@hkbu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants cannot be blinded. However, they will be unaware of the true aim of the study and will be informed that the intervention is intended to enhance overall well-being. Outcome measures will be administered by research personnel who are blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 9, 2025
• Study Start: November 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will be available after the publication of the main results for 3 years.
• Access Criteria: Study protocol, statistical analysis plan, and analytic code will be deposited in an open registry when the study is published for academic use only.

Locations

HK (1)