Nurse-Guided BBTi for Improving Insomnia
Study Details
Study Description
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-guided BBTi in adults with insomnia complaints. In this assessor-blinded randomized controlled trial, participants will be randomly allocated to the nurse-guided 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 Epworth sleepiness scale, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment and posttreatment. We hypothesize that adults with insomnia complaints undergoing nurse-guided BBTi will experience greater alleviations in sleep in comparison with participants in the sleep hygiene control group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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-guided BBTi in adults with insomnia complaints. We hypothesize that adults with insomnia complaints undergoing nurse-guided 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 62 adults with insomnia complaints will be randomly allocated to the nurse-guided BBTi, or sleep hygiene control group in a 1:1 ratio. For the nurse-guided BBTi group, all participants will experience 4-week nurse-guided 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 Epworth sleepiness scale, Chinese version of Pittsburgh sleep quality index, and sleep diary. Questionnaires will be assessed in pretreatment and posttreatment. A generalized estimating equation will be used to test research hypotheses.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Nurse-guided BBTi intervention group Participants will experience 4-week treatment period (2 in person and 2 via telephone). |
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.
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| No Intervention: Control group 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. |
Outcome Measures
Primary Outcome Measures
- Changes in Sleep parameters from sleep logs: sleep onset latency(SOL) [At baseline and week 1 to 3 (during the intervention)]
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.
- Changes in Sleep parameters from sleep logs: after sleep onset(WASO) [At baseline and week 1 to 3 (during the intervention)]
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.
- Changes in Sleep parameters from sleep logs: total sleep time(TST) [At baseline and week 1 to 3 (during the intervention)]
Total sleep time(TST) is the total time of falling asleep. TST will be used to calculate sleep efficiency(SE).
- Changes in Sleep parameters from sleep logs: sleep efficiency(SE) [At baseline and week 1 to 3 (during the intervention)]
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%.
- Changes in Insomnia Severity [At baseline and week 5 (follow up)]
Insomnia Severity will be measured by Chinese version Insomnia Severity Index (ISI). ISI has 7 questions to evaluate sleep difficulty. The score range from 0-28, if score>7 is associated with insomnia. The higher score means more severe insomnia.
- Changes in Sleep quality [At baseline and week 5 (follow up)]
Sleep quality will be measured by Pittsburgh Sleep Quality Index (PSQI). PSQI has 18 questions to evaluate sleep condition. The score range from 0-21, if score>5 is associated with poor sleep. The higher score means poorer sleep quality.
Secondary Outcome Measures
- Changes in Quality of life [At baseline and week 5 (follow up)]
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.
- Changes in Daytime Sleepiness [At baseline and week 5 (follow up)]
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 score range from 0-24, if score>10 is associated with daytime sleepiness.
- Changes in Depression [At baseline and week 5 (follow up)]
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.
- Changes in Anxiety [At baseline and week 5 (follow up)]
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.
- Changes in Stress [At baseline and week 5 (follow up)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months
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Have insomnia with a total score ≥ 8 on the Chinese version of the insomnia severity index (CISI) at screening
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Be able to communicate in Mandarin Chinese
Exclusion Criteria:
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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
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Shift workers
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Women who are pregnant, breastfeeding, or in the menopausal transition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taipei Medical University | Taipei | Taiwan | 110 |
Sponsors and Collaborators
- Taipei Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- N202111028