CBT-I: Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition

Sponsor
Tri-Service General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06013085
Collaborator
(none)
100
2
35

Study Details

Study Description

Brief Summary

Background: Neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are the most common symptoms experienced by nurses after acute infection of COVID-19. Although medication can assist nurses to improve these symptoms simultaneously in a short period of time, they are at risk of overuse of benzodiazepine hypnotics. Previous research supports the usefulness of cognitive behavioral therapy for insomnia (CBT-I) as self-management strategies in adults with insomnia, anxiety, depression, and pain. However, their effects on post COVID-19 condition have not been researched, and no previous head-to-head study compared the effects on these two approaches on insomnia and neuropsychiatric symptoms.

Aim: To investigate the effects of CBT-I on insomnia, anxiety, depression, and pain in nurses with post COVID-19 condition.

Methods: In this two-arm, parallel randomized controlled trial, 100 participants will be 1:1 randomly assigned to one of two groups (CBT-I and control). The intervention phase will last 6 weeks, followed by a three-month follow-up. Primary outcomes are insomnia severity and sleep quality, whereas anxiety, depression, pain, and health-related quality of life are secondary outcomes. These variables will be assessed before and after the intervention, and at 1, 2, and 3 months after the end of the intervention. Additionally, discontinuing benzodiazepine hypnotics will be measured at 3 months after the end of the intervention.

Discussion: This study will provide evidence of the effects of CBT-I on improving insomnia, anxiety, depression, and pain among nurses with post COVID-19 condition. Results could also enhance means by which to discontinue benzodiazepine hypnotics.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: cognitive behavioral therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2026
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: cognitive behavioral therapy

6 weeks cognitive-behavioral therapy for insomnia

Behavioral: cognitive behavioral therapy
6 weeks cognitive behavioral therapy

No Intervention: treat as usual

provide usual care

Outcome Measures

Primary Outcome Measures

  1. insomnia severity [20 weeks]

    measured by Insomnia Severity Index before and after the intervention, and at 1, 2, and 3 months after the end of the intervention

  2. sleep quality [20 weeks]

    measured by Pittsburgh Sleep Quality Index

  3. sleep efficiency [20 weeks]

    measured by Fitbit Charge 5

Secondary Outcome Measures

  1. anxiety [20weeks]

    measured by Generalized Anxiety Disorder 7-Item

  2. depression [20weeks]

    measured by Patient Health Questionnaire 9 item

  3. health-related quality of life [20weeks]

    measured by 36-Item Short Form Health Survey

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • nurses with post COVID-19 condition
Exclusion Criteria:
  • history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tri-Service General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wen-Chii Tzeng, Professor, Tri-Service General Hospital
ClinicalTrials.gov Identifier:
NCT06013085
Other Study ID Numbers:
  • A202205210
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2023