Clinical trial NCT04876001: Nurse-Led BBTi for Post-stroke Insomnia
Official title: Effects of Nurse-Led Brief Behavioral Treatment for Insomnia Following Stroke: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study aims to compare face-to-face and internet-based nurse-led BBTI compare to a wait-list conditions in the stroke population. This study is a parallel, three-arm, randomized controlled trial (RCT). Each participant will be randomized into one of the treatment arms; face-to-face BBTI, internet-based BBTI, and waiting-list. The BBTI, emphasizes behavioral aspects of insomnia care, arises from techniques of sleep restriction and stimulus control. The face-to-face and internet-based BBTI have equivalent content based on the standard portion. All participants will be asked to fill the online questionnaires at weeks 0 (baseline), 1 (mid-treatment), 2 (post-treatment), 4, and 12 (follow up). After the final follow-up, the waiting-list participants will be allowed to join the internet-based BBTI treatment. Our hypotheses are that patients with stroke who receive face-to-face or internet-based BBTI, compared to a wait-list condition, will experience fewer insomnia complaints.

Detailed description: Post-stroke insomnia is a common complaint with prevalence rates remain high. Patients suffering from insomnia following stroke could impair their health-related quality of life and negative rehabilitation outcomes. Identifying effective treatment in managing post-stroke insomnia has become clinically relevant.

Brief behavioral therapy for insomnia (BBTI), a 4-section of treatment for insomnia, has similar treatment components with CBTI, with the exception of cognitive therapy. Previous evidence found that both BBTI and CBTI have comparable effects on improving sleep quality and consolidation. Existing literature has suggested that BBTI was effective on mitigating primary and comorbid insomnia. Nonetheless, thus far, no study has explored its effects in stroke population. Of note, BBTI still requires certain contact with therapists. To enhance the widespread dissemination of BBTI, it is important to establish the internet-based BBTI treatment model (more flexible time schedule) to target more populations with insomnia. The recent study of the online tailored BBTI has proven the comparable effects to reduce insomnia severity in the general population. However, no study investigates the efficacy of internet-based nurse-led BBTI in the stroke population.

Eligibility criteria: Inclusion Criteria:

* Had diagnosed with stroke for at least 3 months (chronic phase)
* Had NIHSS score \< 6
* Complain insomnia symptom based on the score of ISI\> 7
* Having sufficient cognitive function to complete tasks,
* Able to access to internet

Exclusion Criteria:

* The people receiving BBTI and other psychological treatment for insomnia
* Doing shift work
* Having psychiatric disorders
* Being pregnant or breastfeeding
* Having other sleep disorders (e.g., sleep apnea)
* Drugs or alcohol abuse,
* Serious or unstable medical condition prior to the study

Primary outcomes:
measure: Insomnia severity ("change" is being assessed)
timeFrame: Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).
measure: Sleep parameters ("change" is being assessed)
timeFrame: Baseline and up to week 4 (immediately after the intervention)
Secondary outcomes:
measure: Depression ("change" is being assessed)
timeFrame: Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).
measure: Anxiety ("change" is being assessed)
timeFrame: Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).
measure: Fatigue ("change" is being assessed)
timeFrame: Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).
measure: Sleepiness ("change" is being assessed)
timeFrame: Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Hsiao-Yean Chiu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hasan F, Gordon C, Wu D, Huang HC, Yuliana LT, Susatia B, Marta OFD, Chiu HY. Dynamic Prevalence of Sleep Disorders Following Stroke or Transient Ischemic Attack: Systematic Review and Meta-Analysis. Stroke. 2021 Jan;52(2):655-663. doi: 10.1161/STROKEAHA.120.029847. Epub 2021 Jan 7.