Nurse-Led BBTi for Post-stroke Insomnia

NCT ID: NCT04876001

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-02-28

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Face-to-face BBTI

The BBTI consists of two in-person sessions on week 1 and 3 and two session on week 2 and 4 as the "booster" delivered by phone call.

Group Type: EXPERIMENTAL

Brief Behavior Therapy for Insomnia

Intervention Type: BEHAVIORAL

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.

Web-based BBTI

The BBTI consists of two in-person sessions on week 1 and 3 and two session on week 2 and 4 as the "booster" delivered by phone call. All treatments will be delivered using pre-established web and telephone.

Group Type: EXPERIMENTAL

Brief Behavior Therapy for Insomnia

Intervention Type: BEHAVIORAL

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.

Waiting-list

The participant in this arm will be asked to filled the online questionnaires at weeks 0 (baseline), 1 (mid-treatment), 2 (post-treatment), 4 and 12 (follow up). After the final follow up, all participants will be allowed to join the web-based BBTI treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hsiao-Yean Chiu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsiao-Yean Chiu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 33406871 (View on PubMed)

Other Identifiers

IRB 2290/KEPK/II/2021

Identifier Type: -

Identifier Source: org_study_id