NCT04876001Completed
Nurse-Led BBTi for Post-stroke Insomnia
Effects of Nurse-Led Brief Behavioral Treatment for Insomnia Following Stroke: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 28 Mar 2021
- Start date
- Nov 2022
- Primary completion date
- Dec 2023
- Lead sponsor
- Taipei Medical University
- Diseases
- Stroke
- NCT number
- NCT04876001
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From Nov 2022 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The people receiving BBTI and other psychological treatment for insomnia
- Drugs or alcohol abuse,
- Serious or unstable medical condition prior to the study
Other illness
- Having psychiatric disorders
- Having other sleep disorders (e.g., sleep apnea)
Other
- Doing shift work
- Being pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taipei Medical University Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.