Health TrialsbyHealthPanel

Digitally-Assisted Brief Behavioral Treatment for Insomnia in College Students

ConditionInsomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorTaipei Medical University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: interactive e-book BBTI groupExperimental treatment 1 intervention
Group B: BBTI-APP groupExperimental treatment 1 intervention
Group C: sleep hygiene groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline, week 1 to 4 (during the intervention), and one month (follow-up)
2

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.

Time frame
At baseline, week 1 to 4 (during the intervention), and one month (follow-up)
3

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).

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

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

Secondary outcomes

1

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.

Time frame
At baseline, week 4 (after the intervention), and one month (follow-up)
2

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.

Time frame
At baseline, week 4 (after the intervention), and one month (follow-up)
3

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: