Clinical trial NCT05310136: Nurse-led BBTI for Improving Insomnia Severity
Official title: Effects of Nurse-led Brief Behavioral Treatment for Insomnia: A Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: BBTI
adult
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Background: Insomnia, defined as difficulty initiating and maintaining sleep such that it interferes with daytime function, is a common complaint among the general population, which in turn undermine their mood, cognitive functions, and quality of life. 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.

Purposes: 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. 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.

Methods: This assessor-blinded randomized controlled trial will employ a two-arm parallel-group design. A total of 42 adults with insomnia complaints will be randomly allocated to the nurse-led BBTI, or sleep hygiene control group in a 1:1 ratio. For the nurse-led BBTI group, all participants will experience 4-week nurse-led BBTi via 2 in person and 2 telephone sessions. The contents include sleep hygiene, stimulus control, sleep restriction, and relaxation. For the sleep hygiene control group, they will receive usual care, sleep hygiene education, and weekly LINE contacts. 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. A generalized estimating equation will be used to test research hypotheses.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. Shift workers
3. Women who are pregnant, breastfeeding, or in the menopausal transition

Primary outcomes:
measure: Changes in Sleep parameters from sleep logs: sleep onset latency(SOL)
timeFrame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
measure: Changes in Sleep parameters from sleep logs: after sleep onset(WASO)
timeFrame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
measure: Changes in Sleep parameters from sleep logs: total sleep time(TST)
timeFrame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
measure: Changes in Sleep parameters from sleep logs: sleep efficiency(SE)
timeFrame: At baseline, week 1 to 3 (during the intervention), and one month (follow-up)
measure: Changes in Insomnia Severity
timeFrame: At baseline, week 5 (after the intervention), and one month (follow-up)
measure: Changes in Sleep quality
timeFrame: At baseline, week 5 (after the intervention), and one month (follow-up)
Secondary outcomes:
measure: Changes in Quality of life
timeFrame: At baseline, week 5 (after the intervention), and one month (follow-up)
measure: Changes in Daytime Sleepiness
timeFrame: At baseline, week 5 (after the intervention), and one month (follow-up)
measure: Changes in Depression
timeFrame: At baseline, week 5 (after the intervention), and one month (follow-up)
measure: Changes in Anxiety
timeFrame: At baseline, week 5 (after the intervention), and one month (follow-up)
measure: Changes in Stress
timeFrame: At baseline, week 5 (after the intervention), and one month (follow-up)
measure: Changes in Fatigue
timeFrame: At baseline, week 5 (after the intervention), and one month (follow-up)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References: