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Research article
Magdalena Esteva
Majorca Primary Care Department
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8238-7891
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Cognitive behavioral therapy (CBT) is the treatment of choice for chronic insomnia but is underutilized in patients in primary care. The purpose of this study was to assess the feasibility and acceptability of a pilot cluster-randomized study of CBT for chronic insomnia (CBT-i) in a primary care setting.
Methods: This pilot-feasibility study with a parallel cluster-randomized design comparing CBT-i-intervention group (IG) and usual care (UC) was performed at two primary health care centers in Majorca, Spain. Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ³ 8) and had insomnia longer than 3 months; and did or did not use a hypnotic medication. A total of 25 GPs and nurses and 32 patients were randomly allocated to two groups. The outcome of the intervention was improvement in quality of sleep. Other primary outcomes were the feasibility and applicability of the intervention, which were defined using nominal groups. UC was defined based on previous studies. The recruitment process, compliance with intervention sessions, and patient retention were also assessed.
Results: We adapted the CBT-i approach of Morin to a primary care context. After intervention training, primary care providers (PCPs) expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer and shorter sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, significantly higher proportions of patients in the IG had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions.
Conclusions: This pilot-feasibility study identified several key issues that must be addressed before performing CBT-i intervention in future clinical trials in a primary care setting.
Trial registration: NCT04565223. (Clinical trials.gov) Registered 1 September 2020 - Retrospectively registered.
Keywords
Insomnia, treatment, primary care, cognitive behavioral therapy, randomized controlled trial, feasibility study, pilot study
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View the published article at BMC Family Practice.
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Posted 04 Dec, 2020
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Editorial decision: Minor revision
On 22 Jan, 2021
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On 20 Jan, 2021
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Received 20 Jan, 2021
Review #1 received
Received 13 Dec, 2020
Reviewer #1 agreed
On 08 Dec, 2020
Reviewers invited
Invitations sent on 04 Dec, 2020
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On 30 Nov, 2020
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On 30 Nov, 2020
Editor invited
On 30 Nov, 2020
First submitted
On 18 Oct, 2020
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Subject Areas
General Practice
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See the published version of this preprint at BMC Family Practice.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Magdalena Esteva
Majorca Primary Care Department
Corresponding Author
ORCiD: https://orcid.org/0000-0001-8238-7891
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Family Practice.
Version 1
Posted 04 Dec, 2020
No community comments so far
Editorial decision: Minor revision
On 22 Jan, 2021
Reviewer #2 agreed
On 20 Jan, 2021
Review #2 received
Received 20 Jan, 2021
Review #1 received
Received 13 Dec, 2020
Reviewer #1 agreed
On 08 Dec, 2020
Reviewers invited
Invitations sent on 04 Dec, 2020
Editor assigned
On 30 Nov, 2020
Submission checks complete
On 30 Nov, 2020
Editor invited
On 30 Nov, 2020
First submitted
On 18 Oct, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Practice
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Family Practice.
Background: Cognitive behavioral therapy (CBT) is the treatment of choice for chronic insomnia but is underutilized in patients in primary care. The purpose of this study was to assess the feasibility and acceptability of a pilot cluster-randomized study of CBT for chronic insomnia (CBT-i) in a primary care setting.
Methods: This pilot-feasibility study with a parallel cluster-randomized design comparing CBT-i-intervention group (IG) and usual care (UC) was performed at two primary health care centers in Majorca, Spain. Patients were included if they were 18 to 65 years-old; had diagnoses of chronic insomnia according to the Insomnia Severity Index (ISI ³ 8) and had insomnia longer than 3 months; and did or did not use a hypnotic medication. A total of 25 GPs and nurses and 32 patients were randomly allocated to two groups. The outcome of the intervention was improvement in quality of sleep. Other primary outcomes were the feasibility and applicability of the intervention, which were defined using nominal groups. UC was defined based on previous studies. The recruitment process, compliance with intervention sessions, and patient retention were also assessed.
Results: We adapted the CBT-i approach of Morin to a primary care context. After intervention training, primary care providers (PCPs) expressed the need for more extensive training in the different aspects of the therapy and the discussion of more cases. PCPs considered the intervention as adequate but wanted fewer and shorter sessions as well as to discard the cognitive restructuring component. PCPs considered it crucial to prepare each session in advance and to establish a specific agenda for the CBT-i. Regular reminders given to PCPs and patients were suggested to improve study participation. Compared to the UC group, significantly higher proportions of patients in the IG had short sleep latency, slept for longer than 5 h, and had fewer sleep disruptions.
Conclusions: This pilot-feasibility study identified several key issues that must be addressed before performing CBT-i intervention in future clinical trials in a primary care setting.
Trial registration: NCT04565223. (Clinical trials.gov) Registered 1 September 2020 - Retrospectively registered.
Figure 1
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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