Nurse-Led BBTi for Post-stroke Insomnia

NCT04876001 | Completed DMC

• 1 other identifier: IRB 2290/KEPK/II/2021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• Insomnia severity ("change" is being assessed)

  Insomnia Severity Index (ISI) will be used to measure the concept of insomnia symptoms. The total score is 0-28, where cutoff point score\> 7 indicated as the presence of insomnia. The higher scores indicate severe condition.

  Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).

• Sleep parameters ("change" is being assessed)

  The Sleep Diary (SD) will be used to measure the subjective sleep parameters, including total sleep time, sleep onset latency, wake after sleep onset, sleep efficiency, and sleep quality. The good result such as total sleep time between 6-8 hours, sleep onset latency less than 30 minutes, wake after sleep onset less than 30 minutes, sleep efficiency greater than 85%, and sleep quality is good.

  Baseline and up to week 4 (immediately after the intervention)

Secondary Outcomes (4)

• Depression ("change" is being assessed)

  Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).

• Anxiety ("change" is being assessed)

  Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).

• Fatigue ("change" is being assessed)

  Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).

• Sleepiness ("change" is being assessed)

  Baseline, week 2 (during the intervention), week 4 (immediately after the intervention), and week 12 (follow up).

Study Arms (3)

Face-to-face BBTI

EXPERIMENTAL

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.

Behavioral: Brief Behavior Therapy for Insomnia

Web-based BBTI

EXPERIMENTAL

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.

Behavioral: Brief Behavior Therapy for Insomnia

Waiting-list

NO INTERVENTION

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.

Interventions

Brief Behavior Therapy for Insomnia 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.

Face-to-face BBTI; Web-based BBTI

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 33406871 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Hsiao-Yean Chiu, Ph.D.

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During the trial, the data collector will be blinded to the random assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: May 6, 2021
• Study Start: November 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: February 28, 2024
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)