Digitally-Assisted Brief Behavioral Treatment for Insomnia in College Students

Effects of Digitally-Assisted Brief Behavioral Treatment for Insomnia in College Students: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Interactive E-book BBTI Group; Behavioral: BBTI-APP Group

Detailed Description

Background： Insomnia is a common health problem faced by college students. It not only causes poor academic performance and reduces the quality of life, but also increases the risk of mood disorders and suicide. However, insomnia among college students has long been ignored by health care providers. Currently, insomnia drugs and cognitive behavioral therapy for insomnia are mostly used clinically to treat insomnia. However, there are no long-term use guidelines for insomnia drugs for teenagers. Cognitive behavioral therapy for insomnia is a treatment that is expensive, time-consuming, and lacks accessibility.

Purpose： 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. 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.

Method： The study is a single-blind study, parallel randomized controlled trial method. It is anticipate to include 30 college students, who will be randomly assigned to the BBTI-APP group (10 people) and the interactive e-book BBTI group (10 people) in a ratio of 1:1:1. and sleep hygiene team (10 people). If assigned to the BBTI-APP group, college students can use the mobile phone app to record sleep, watch BBTI treatment content and sleep hygiene, perform muscle relaxation and listen to relaxing music. The study intervention time is four weeks in total.

Anticipated Results：

1. BBTI-APP and interactive e-book BBTI can effectively improve the severity of insomnia, sleep quality and mood of college students
2. It enables researchers to gain relevant knowledge and experience in using BBTI-APP and BBTI e-books to improve college students' insomnia severity, sleep quality and mood.

Keywords：Digital, Brief Behavioral Treatment for Insomnia,BBT-I, insomnia, mood, college students

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsiao-Yean Chiu, Professor; Phone Number: 886-2-27361661; Email: hychiu0315@tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei Medical University
    • Contact: Hisao Yean Chiu, PhD; Phone Number: 6329 886227361661; Email: hychiu0315@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: With an electronic mobile device that can access the Internet, reporting insomnia including falling asleep more than three days a week or being awake at night for ≥30 minutes for more than 3 months, screened by the Chinese version of the Insomnia Severity Index- Chinese Version -C, with a total score of ≥10 points, can communicate in Chinese and complete the research questionnaire -

Exclusion Criteria: Those entering internship, shift workers, those with a history of epilepsy, those with other sleep disorders such as sleep apnea, those currently diagnosed with mental illness, substance abuse or alcohol addiction.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interactive e-book BBTI group; Participants will experience 5-week treatment period (1 in person and 4 via message).	Behavioral: Interactive E-book BBTI Group; 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.
Experimental: BBTI-APP group; Participants will experience 5-week treatment period (1 in person and 4 via message).	Behavioral: BBTI-APP Group; 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.
No Intervention: sleep hygiene group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Depression	Depression will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of depression.	At baseline, week 4 (after the intervention), and one month (follow-up)
Changes in Anxiety	Anxiety will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of anxiety. The total score should be multiplied by 2 range from 0-42, if score>7 is associated with anxiety. The higher score means more severe anxiety.	At baseline, week 4 (after the intervention), and one month (follow-up)
Changes in Stress	Stress will be measured by Depression Anxiety Stress Scale-21 (DASS21). DASS21 has 21 questions to evaluate the state of depression, anxiety, and stress. 7 of the questions are used to measure the severity of stress. The total score should be multiplied by 2 range from 0-42, if score>14 is associated with anxiety. The higher score means more severe stress.	At baseline, week 4 (after the intervention), and one month (follow-up)

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 4, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: college students; BBTI; Digitally-Assisted BBTI; undergrate students
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: N202502044

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