Digitally-Assisted Brief Behavioral Treatment for Insomnia in College Students

Official title

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

Overview

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.

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

Interventions

• 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.
• 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.

Primary outcome measures

• Changes in Sleep parameters from sleep logs: sleep onset latency(SOL) [Time frame: 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) [Time frame: 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) [Time frame: At baseline, week 1 to 4 (during the intervention), and one month (follow-up)]
• Changes in Sleep parameters from sleep logs: sleep efficiency(SE) [Time frame: Time Frame: At baseline, week 1 to 4 (during the intervention), and one month (follow-up)]
• Changes in Insomnia Severity [Time frame: At baseline, week 5 (after the intervention), and one month (follow-up)]

Secondary outcome measures (3)

• Changes in Depression [Time frame: At baseline, week 4 (after the intervention), and one month (follow-up)]
• Changes in Anxiety [Time frame: At baseline, week 4 (after the intervention), and one month (follow-up)]
• Changes in Stress [Time frame: At baseline, week 4 (after the intervention), and one month (follow-up)]

Eligibility criteria

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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Taipei Medical University — Taipei

Identifiers

NCT: NCT07114302 · N202502044

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗