Cognitive Behavioral TherapyCBT-INCT06013085
Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
A study testing cognitive behavioral therapy in people with Cognitive Behavioral Therapy, run by Tri-Service General Hospital (TSGH).
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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Behavioral Therapy
- What is being tested?
- cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nurses with post COVID-19 condition
Who cannot join
- history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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
- Being tested
- cognitive behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
6 weeks cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioral therapy | Experimental | 6 weeks cognitive-behavioral therapy for insomnia Receives: Behavioral: cognitive behavioral therapy |
| treat as usual | No intervention | provide usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 weeks
sleep quality
measured by Pittsburgh Sleep Quality Index
Measured: 20 weeks
sleep efficiency
measured by Fitbit Charge 5
Measured: 20 weeks
Secondary outcomes (3)
anxiety
measured by Generalized Anxiety Disorder 7-Item
Measured: 20weeks
depression
measured by Patient Health Questionnaire 9 item
Measured: 20weeks
health-related quality of life
measured by 36-Item Short Form Health Survey
Measured: 20weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavioral TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Chii Tzeng, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013085
- Sponsor's protocol ID
- A202205210
- Acronym
- CBT-I
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available on request due to privacy/ethical restrictions
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
- ClinicalTrials.gov ID
- NCT06013085
- Acronym / sponsor ID
- CBT-I / A202205210
- Conditions
- Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral therapy | Experimental | Behavioral: cognitive behavioral therapy6 weeks cognitive-behavioral therapy for insomnia |
| treat as usual | No intervention | –provide usual care |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nurses with post COVID-19 condition
Key exclusion criteria (1 listed)
- history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapy6 weeks cognitive behavioral therapy | Behavioural | cognitive behavioral therapy |
Primary outcome
insomnia severity
Time frame: 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
sleep quality
Time frame: 20 weeks
measured by Pittsburgh Sleep Quality Index
sleep efficiency
Time frame: 20 weeks
measured by Fitbit Charge 5
3 secondary outcomes
anxiety
Time frame: 20weeks
depression
Time frame: 20weeks
health-related quality of life
Time frame: 20weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No. Data available on request due to privacy/ethical restrictions
Related trials for Cognitive Behavioral Therapy
Not yet recruiting
Efficacy of Cognitive Behavioral Therapy at Vestibular Migraine
Cognitive Behavioral Therapy to Medical Treatment on Functional Ability of Patients With Vestibular Migraine
Not yet recruiting
Digitally Enhanced Cognitive-Behavioral Therapy
Depression in Adolescence, Obesity & Overweight
Recruiting
Internet-Based Cognitive Behavioural Therapy (iCBT) for Anxiety and Depression in Singapore
Depression and/or Anxiety in the Mild-to-moderate Range, Cognitive Behavioral Therapy
Recruiting
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Cognitive Behavioral Therapy, Obsessive-Compulsive Disorder
Active, not recruiting
Novel Mental Health Therapies to Improve Military Readiness
Anxiety, Alpha Stim
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy in people with Cognitive Behavioral Therapy, run by Tri-Service General Hospital (TSGH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Mu Hsien, PhD (886-2-87923311 ext. 10552, tsghirb@ndmctsgh.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insomnia severity (time frame: 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.