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

NCT06013085 | Not Yet Recruiting

• 1 other identifier: A202205210
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (3)

• insomnia severity

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

  20 weeks

• sleep quality

  measured by Pittsburgh Sleep Quality Index

  20 weeks

• sleep efficiency

  measured by Fitbit Charge 5

  20 weeks

Secondary Outcomes (3)

• anxiety

  20weeks

• depression

  20weeks

• health-related quality of life

  20weeks

Study Arms (2)

cognitive behavioral therapy

EXPERIMENTAL

6 weeks cognitive-behavioral therapy for insomnia

Behavioral: cognitive behavioral therapy

treat as usual

NO INTERVENTION

provide usual care

Interventions

cognitive behavioral therapy BEHAVIORAL

6 weeks cognitive behavioral therapy

cognitive behavioral therapy

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nurses with post COVID-19 condition

You may not qualify if:

• history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker

Sponsors & Collaborators

• Tri-Service General Hospital: lead

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Yu-Mu Hsien, PhD

CONTACT

886-2-87923311; tsghirb@ndmctsgh.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 28, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share