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Completed

NCT Number: NCT04876001

Nurse-Led BBTi for Post-stroke Insomnia

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Insomnia severity ("change" is being assessed)

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

    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.

  2. Sleep parameters ("change" is being assessed)

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

    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.

Secondary outcomes

  1. Depression ("change" is being assessed)

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

    We will use the Patient Health Questionaire-9 (PHQ-9). The total score of 0-27 and cutoff point> 10 of the total score were indicated as having post-stroke depression. The higher scores indicate more depression.

  2. Anxiety ("change" is being assessed)

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

    We will use the Generalized Anxiety Disorder-7 (GAD-7). The total score of 0-21 and cutoff point> 8 of the total score were indicated as having anxiety. The higher scores indicate more anxiety.

  3. Fatigue ("change" is being assessed)

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

    We will use the Fatigue Assessment Scale (FAS). The total score of 10-50 and the cutoff point> 22 was considered of having fatigue. The higher scores indicate more fatigue.

  4. Sleepiness ("change" is being assessed)

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

    We will use the Epworth Sleepiness Scale (ESS). The total score is 0-24 with cutoff point>10 were considered of having excessive daytime sleepiness. The higher scores indicate greater excessive daytime sleepiness.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 6, 2021
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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