Digitally-Assisted Brief Behavioral Treatment for Insomnia in College Students

NCT07114302 | Not Yet Recruiting

• 1 other identifier: N202502044
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a single-blind study, parallel randomized controlled trial method. The purpose of this study was to explore the effectiveness of the mobile version of Application based Brief Behavioral Treatment for Insomnia (BBTI-APP) and the interactive e-book version of BBTI in improving the severity of insomnia, sleep quality and mood among college students. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of The Depression, Anxiety and Stress Scale - 21 Items, and sleep diary. Questionnaires will be assessed in pretreatment, posttreatment, and one-month follow-up. We hypothesized that compared with the sleep hygiene group, both the BBTI-APP and the interactive e-book BBTI can significantly improve college students' insomnia symptoms, emotional distress, and quality of life.

Conditions

Insomnia

Keywords

college students; Digitally-Assisted BBTI; BBTI; undergrate students

Outcome Measures

Primary Outcomes (5)

• Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)

  Sleep onset latency(SOL) is the time of duration from lying on bed to fall asleep. SOL shorter than 30 minutes is one of criteria of good sleep condition.

  At baseline, week 1 to 4 (during the intervention), and one month (follow-up)

• Changes in Sleep parameters from sleep logs: after sleep onset(WASO)

  Wake after sleep onset(WASO) is the total time of wakefulness after sleep onset. WASO less than 30 minutes is one of criteria of good sleep condition.

  At baseline, week 1 to 4 (during the intervention), and one month (follow-up)

• Changes in Sleep parameters from sleep logs: total sleep time(TST)

  Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).

  At baseline, week 1 to 4 (during the intervention), and one month (follow-up)

• Changes in Sleep parameters from sleep logs: sleep efficiency(SE)

  Sleep efficiency(SE) is the percentage of total sleep time to time in bed. A good sleep condition should meet the criteria of SE greater than 85%.

  Time Frame: At baseline, week 1 to 4 (during the intervention), and one month (follow-up)

• Changes in Insomnia Severity

  Insomnia Severity will be measured by Chinese version Insomnia Severity Index (ISI). ISI has 7 questions to evaluate sleep difficulty. The total score range from 0-28, if score\>7 is associated with insomnia. The higher score means more severe insomnia.

  At baseline, week 5 (after the intervention), and one month (follow-up)

Secondary Outcomes (3)

• Changes in Depression

  At baseline, week 4 (after the intervention), and one month (follow-up)

• Changes in Anxiety

  At baseline, week 4 (after the intervention), and one month (follow-up)

• Changes in Stress

  At baseline, week 4 (after the intervention), and one month (follow-up)

Study Arms (3)

interactive e-book BBTI group

EXPERIMENTAL

Participants will experience 5-week treatment period (1 in person and 4 via message).

Behavioral: Interactive E-book BBTI Group

BBTI-APP group

EXPERIMENTAL

Participants will experience 5-week treatment period (1 in person and 4 via message).

Behavioral: BBTI-APP Group

sleep hygiene group

NO INTERVENTION

Participants will received sleep hygiene at the enrollment of the study and be required to maintain their usual lifestyle and medical treatment for 5 weeks.

Interventions

Interactive E-book BBTI Group BEHAVIORAL

Researchers will guide you on how to use the interactive e-book and help install it on your smartphone. Over the next four weeks, you will be asked to record your sleep diary daily. You will use the e-book to perform sleep stimulus control, sleep restriction, and relaxation techniques to promote better sleep. Researchers will contact you via LINE during the second and fourth weeks, and may call you if necessary.

interactive e-book BBTI group

BBTI-APP Group BEHAVIORAL

Researchers will assist you in creating an account for the mobile application and will explain the interface and how to operate it. Over the next four weeks, you will be asked to record your sleep diary daily. You will use the mobile app to carry out sleep stimulus control, sleep restriction, and relaxation techniques to improve sleep. Researchers will contact you via LINE during the second and fourth weeks, and may call you if necessary.

BBTI-APP group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Hsiao-Yean Chiu, Professor

CONTACT

886-2-27361661; hychiu0315@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)