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Influence of sleep quality on health status of peri-menopausal women & effects of cognitive-behavior therapy for insomnia in improving insomnia and reducing cardiovascular disease risks

Status Approved

First Submitted Date

2018/05/31
Registered Date

2018/06/23
Last Updated Date

2018/06/20

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002951
Unique Protocol ID	2014R1A1A3049904
Public/Brief Title	Effects of cognitive-behavior therapy for insomnia in improving insomnia and reducing cardiovascular disease risks
Scientific Title	Influence of sleep quality on health status of peri-menopausal women & effects of cognitive-behavior therapy for insomnia in improving insomnia and reducing cardiovascular disease risks
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	150401-1A
Approval Date	2015-05-22
Institutional Review Board Name	Inha University Institutional Review Board
Institutional Review Board Address	100, Inha-ro, Nam-gu, Incheon
Institutional Review Board Telephone	032-860-7154
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Ok Kyung Ham
Title	Professor
Telephone	+82-32-860-8211
Affiliation	Inha University
Address	100 Inha-ro, Nam-gu Incheon, Korea (ROK) 22212
Contact Person for Public Queries
Name	Ok Kyung Ham
Title	Professor
Telephone	+82-32-860-8211
Affiliation	Inha University
Address	100 Inha-ro, Nam-gu Incheon, Korea (ROK) 22212
Contact Person for Updating Information
Name	Ok Kyung Ham
Title	Professor
Telephone	+82-32-860-8211
Affiliation	Inha University
Address	100 Inha-ro, Nam-gu Incheon, Korea (ROK) 22212

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2015-05-25 Actual
Target Number of Participant	68
Primary Completion Date	2017-08-31 , Actual
Study Completion Date	2017-08-31 , Actual
Name of Study	Planned Population Federation of Korea
Recruitment Status	Completed
Date of First Enrollment	2015-05-25 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Research Foundation
Organization Type	Others
Project ID	2014R1A1A3049904

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Inha University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	Insomnia is prevalent among middle-aged women, and is associated with deteriorated physical and psychological health. Therefore, the prevention and alleviation of disrupted sleep are critical to the health and quality of life of middle-aged women. The cognitive behavioral therapy for insomnia (CBT-I) is effective in decreasing the menopausal symptoms and sleep disturbances among women, as well as improving their quality of life. Therefore, this study developed and offered the CBT-I targeting middle-aged women who had been experiencing insomnia and/or poor sleep quality, and assessed the efficacy of CBT-I on the outcome variables (insomnia, sleep quality, CVD risks, depression, and quality of life). The purpose of this study was to examine whether cognitive-behavioral therapy for insomnia (CBT-I) was effective in mitigating sleep symptoms and in improving health and quality of life of women. Our study also aimed to analyze long-term effects of sleep on cardiovascular disease (CVD) risks among middle-aged women. A randomized controlled trial (RCT) will be performed to determine the efficacy of CBT-I on disrupted sleep, CVD risk reduction, and psychosocial health targeting 68 middle-aged women with insomnia and/or poor sleep quality. CBT-I intervention will be developed through literature review, needs assessment with women, and expert panel review. As a safe treatment option, CBT-I can help to improve sleep while decreasing the harmful side effects of sleeping pills. In addition, CBT-I could be offered to those having borderline insomnia in the community, who do not seek medical treatment but aim to prevent further exacerbation of their disturbed sleep and the corresponding health effects.

Study Summary Information

Lay Summary

Insomnia is prevalent among middle-aged women, and is associated with deteriorated physical and psychological health. Therefore, the prevention and alleviation of disrupted sleep are critical to the health and quality of life of middle-aged women. The cognitive behavioral therapy for insomnia (CBT-I) is effective in decreasing the menopausal symptoms and sleep disturbances among women, as well as improving their quality of life. Therefore, this study developed and offered the CBT-I targeting middle-aged women who had been experiencing insomnia and/or poor sleep quality, and assessed the efficacy of CBT-I on the outcome variables (insomnia, sleep quality, CVD risks, depression, and quality of life).

The purpose of this study was to examine whether cognitive-behavioral therapy for insomnia (CBT-I) was effective in mitigating sleep symptoms and in improving health and quality of life of women. Our study also aimed to analyze long-term effects of sleep on cardiovascular disease (CVD) risks among middle-aged women.

A randomized controlled trial (RCT) will be performed to determine the efficacy of CBT-I on disrupted sleep, CVD risk reduction, and psychosocial health targeting 68 middle-aged women with insomnia and/or poor sleep quality. CBT-I intervention will be developed through literature review, needs assessment with women, and expert panel review.

As a safe treatment option, CBT-I can help to improve sleep while decreasing the harmful side effects of sleeping pills. In addition, CBT-I could be offered to those having borderline insomnia in the community, who do not seek medical treatment but aim to prevent further exacerbation of their disturbed sleep and the corresponding health effects.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Health Services Research
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Behavioral
Intervention Description	Cognitive Behavioral Therapy for Insomnia (CBT-I)
Number of Arms	2
Arm 1	Arm Label experimental group
	Target Number of Participant 34
	Arm Type Experimental
	Arm Description CBT-I (4 individual sessions), sleep hygiene education (1 group session), counseling booklet,
Arm 2	Arm Label control group
	Target Number of Participant 34
	Arm Type Active comparator
	Arm Description sleep hygiene education (1 group session), counseling booklet,

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N95.1)Menopausal and female climacteric states
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 40Year~65Year
	Description Inclusion criteria -women, -aged between 40–65 years, -able to read and understand the Korean language, -who understood the purpose of the study -having insomnia (ISI ≥ 10) or poor sleep quality (PSQI > 5). * Insomnia Severity Index (ISI), * Pittsburg Sleep Quality Index (PSQI)
Exclusion Criteria	Exclusion criteria -Women with mental health problems other than insomnia -obstructive sleep apnea, - using sleeping pills -who underwent cancer therapy were excluded.
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Insomnia
Timepoint	One-month & one- year after the intervention
Primary Outcome(s) 2
Outcome	sleep quality
Timepoint	One-month & one- year after the intervention
Primary Outcome(s) 3
Outcome	Cardiovascular Risk (body mass index, waist circumference, blood pressure, blood glucose, lipid profile)
Timepoint	One-month & one- year after the intervention
Secondary Outcome(s) 1
Outcome	Depression
Timepoint	One-month & one- year after the intervention
Secondary Outcome(s) 2
Outcome	quality of life
Timepoint	One-month & one- year after the intervention

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Published
Final Enrollment Number
Number of Publication	1
Publications 1	함옥경, 김진영, 이보경, 최은주. Behavioral Characteristics and Cardiovascular Disease Risks Associated With Insomnia and Sleep Quality Among Middle-Aged Women in South Korea. RESEARCH IN NURSING & HEALTH. SCI. 2017-06-30 , VOL : 40 page : 206 ~ 217 http://onlinelibrary.wiley.com/doi/10.1002/nur.v40.3/issuetoc
Results Upload	Ham_et_al-2017-Research_in_Nursing_&_Health.pdf
Date of Posting Results	2018/06/23
Protocol URL or File Upload
Brief Summary

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2018. 6
Way of Sharing	Available on Request (okkyung@inha.ac.kr)

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