Nurse-led BBTI for Improving Insomnia Severity

Insomnia Clinical Trial

Official title:

Effects of Nurse-led Brief Behavioral Treatment for Insomnia: A Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310136
• Other study ID #: N202111028
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2024
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 31, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• BBTi
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Changes in Quality of life	Quality of life will be measured by RAND-36 Health Status Inventory. It has 36 questions to assess eight health concepts including physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.	At baseline, week 5 (after the intervention), and one month (follow-up)
Secondary	Changes in Daytime Sleepiness	Daytime Sleepiness will be measured by Epworth Sleepiness Scale (ESS). ESS has 8 questions to evaluate the condition of dozing off or falling asleep. The total score range from 0-24, if score>10 is associated with daytime sleepiness.	At baseline, week 5 (after the intervention), and one month (follow-up)
Secondary	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. The total score should be multiplied by 2 range from 0-42, if score>9 is associated with depression. The higher score means more severe depression.	At baseline, week 5 (after the intervention), and one month (follow-up)
Secondary	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 5 (after the intervention), and one month (follow-up)
Secondary	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 5 (after the intervention), and one month (follow-up)
Secondary	Changes in Fatigue	Stress will be measured by Brief Fatigue Inventory- Taiwan Form (BFI- Taiwan Form). BFI- Taiwan Form has 9 questions to evaluate the state of fatigue. The score of each item range from 0-10, if score>4 is associated with fatigue. The higher score means more severe fatigue.	At baseline, week 5 (after the intervention), and one month (follow-up)