Nurse-led BBTI for Improving Insomnia Severity

NCT05310136 | Completed

• 1 other identifier: N202111028
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Brief behavioral treatment for insomnia (BBTI) is a new treatment direction for primary and comorbid insomnia; however, its treatment model has not been established in Taiwan. This study aims to establish the BBTI treatment model among insomniacs in Taiwan and to examine the immediate effects of nurse-led BBTI in adults with insomnia complaints. In this assessor-blinded randomized controlled trial, participants will be randomly allocated to the nurse-led BBTI experimental group, or sleep hygiene control group. Measurement outcomes are sleep parameters measured by the Chinese version of Insomnia Severity Index, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment, posttreatment, and one-month follow-up. We hypothesize that adults with insomnia complaints undergoing nurse-led BBTI will experience greater alleviations in sleep in comparison with participants in the sleep hygiene control group.

Conditions

Insomnia

Keywords

BBTI; adult

Outcome Measures

Primary Outcomes (6)

• 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 3 (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 3 (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 3 (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%.

  At baseline, week 1 to 3 (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)

• Changes in Sleep quality

  Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The total score range from 0-21, if score\>5 is associated with poor sleep. The higher score means poorer sleep quality.

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

Secondary Outcomes (6)

• Changes in Quality of life

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

• Changes in Daytime Sleepiness

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

• Changes in Depression

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

• Changes in Anxiety

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

• Changes in Stress

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

Study Arms (2)

Nurse-guided BBTi intervention group

EXPERIMENTAL

Participants will experience 4-week treatment period (2 in person and 2 via telephone).

Behavioral: BBTi

Control 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 4 weeks.

Interventions

BBTi BEHAVIORAL

On the arrival for the baseline appointment, participants will receive workbooks which include an outline and content of BBTi, sleep diaries, and adherence record. In the end of weeks 1 and 3, nurse interventionist will meet participants to review their sleep diary data and negotiate their bedtime and wake-time schedule. During the weeks 2 and 4, participants will receive planned follow-up phone calls to assess their adherence and review progress and challenges.

Nurse-guided BBTi intervention group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months
• Have insomnia with a total score ≥ 8 on the Chinese version of the insomnia severity index (CISI) at screening
• Be able to communicate in Mandarin Chinese

You may not qualify if:

• Premorbid diagnoses of seizure, other sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score \> 3), psychiatric diseases, substance abuse, and alcoholism
• Shift workers
• Women who are pregnant, breastfeeding, or in the menopausal transition

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

Related Publications (2)

• Hasan F, Prasetya EC, Gordon CJ, Romadlon DS, Chang KM, Bartlett DJ, Lin CJ, Gautama MSN, Izzati N, Chiu HY. Effects of nurse-led, web-based brief behavioral therapy on insomnia severity in patients in the chronic stage of stroke recovery: a preliminary randomized controlled trial. J Clin Sleep Med. 2025 Dec 1;21(12):2031-2040. doi: 10.5664/jcsm.11856.

  PMID: 40904277 DERIVED

• Chang KM, Lin CJ, Jan YW, Gordon CJ, Lee HC, Shih CY, Bartlett DJ, Fan YC, Chiu HY. Effects of nurse-led brief behavioral treatment for insomnia in adults: a randomized controlled trial. J Clin Sleep Med. 2024 Nov 1;20(11):1763-1772. doi: 10.5664/jcsm.11256.

  PMID: 38935053 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

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: March 16, 2022
• First Posted: April 4, 2022
• Study Start: April 1, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 31, 2023
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)