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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06013085
Acronym
CBT-I
Enrollment
100
Registered
2023-08-28
Start date
2023-09-01
Completion date
2026-07-31
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Behavioral Therapy

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.

Interventions

BEHAVIORALcognitive behavioral therapy

6 weeks cognitive behavioral therapy

Sponsors

Tri-Service General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* nurses with post COVID-19 condition

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
insomnia severity20 weeksmeasured by Insomnia Severity Index before and after the intervention, and at 1, 2, and 3 months after the end of the intervention
sleep quality20 weeksmeasured by Pittsburgh Sleep Quality Index
sleep efficiency20 weeksmeasured by Fitbit Charge 5

Secondary

MeasureTime frameDescription
anxiety20weeksmeasured by Generalized Anxiety Disorder 7-Item
depression20weeksmeasured by Patient Health Questionnaire 9 item
health-related quality of life20weeksmeasured by 36-Item Short Form Health Survey

Contacts

Primary ContactYu-Mu Hsien, PhD
tsghirb@ndmctsgh.edu.tw886-2-87923311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026