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

Cognitive Behavioral Therapy Clinical Trial

— CBT-I  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06013085
• Other study ID #: A202205210
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: August 2023
• Source: Tri-Service General Hospital
• Contact: Yu-Mu Hsien, PhD
• Phone: 886-2-87923311
• Email: tsghirb[@]ndmctsgh.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• nurses with post COVID-19 condition

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cognitive Behavioral Therapy
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• cognitive behavioral therapy
6 weeks cognitive behavioral therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	sleep quality	measured by Pittsburgh Sleep Quality Index	20 weeks
Primary	sleep efficiency	measured by Fitbit Charge 5	20 weeks
Secondary	anxiety	measured by Generalized Anxiety Disorder 7-Item	20weeks
Secondary	depression	measured by Patient Health Questionnaire 9 item	20weeks
Secondary	health-related quality of life	measured by 36-Item Short Form Health Survey	20weeks