NCT04876001

Nurse-Led BBTi for Post-stroke Insomnia

Effects of Nurse-Led Brief Behavioral Treatment for Insomnia Following Stroke: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Brief Behavior Therapy for Insomnia	The BBTI consists of two in-person sessions on week 1 and 3 and two sessions on week 2 and 4 as the "booster" delivered by phone call.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-12-30
• Completion: 2024-02-28
• First posted: 2021-05-06
• Last updated: 2024-04-23

Locations

1 site across 1 country: Taiwan