The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes
2019년 8월 26일 업데이트: Patricia Kluding, PhD, University of Kansas Medical Center
Insomnia and Type 2 Diabetes: Measurement, Impact and Intervention
Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep.
Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D).
Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue.
People with insomnia usually suffer from fatigue and inconstant sleep schedule, which negatively influence quality of life.
However, the additive effect of behavioral sleep intervention on diabetes outcomes and health status in people with T2D is unknown.
Therefore, The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D.
The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.
연구 개요
상세 설명
Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue. People with insomnia usually suffer from fatigue, which negatively influences quality of life. However, the additive effect of insomnia symptoms on diabetes outcomes and health status in people with T2D is unknown. Therefore, it is imperative to investigate the contributing factor that affects DSCB and health outcomes to help individuals with diabetes reach their goals.
Assessing sleep variability is very important clinically and practically for people with insomnia. People with insomnia have higher night to night sleep variability compared to healthy individuals. Compared to other populations, people with T2D might suffer from sleep disturbances due to diabetes symptoms such as frequency nocturnal urination, hyperglycemia, insulin resistance, obesity, pain and fatigue, which might influence the sleep variability. The nature of insomnia is not representable by using mean values, as the reduction in the sleep variability values is a predictor for insomnia and depression recovery. Therefore, understanding the sleep variability in people with T2D with or without insomnia symptoms may add complementary evidence for future studies.
An effective treatment for people with insomnia is Cognitive Behavioral Therapy for Insomnia (CBT-I). CBT-I is superior to sleep medications in terms of cost and long term benefits. Although there is currently limited evidence about the effect of CBT-I on people with T2D, CBT-I is a potentially effective intervention given insomnia's relationship with glucose metabolism. The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D. The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.
연구 유형
중재적
등록 (실제)
28
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age between 40 to 75 years
- Self-reported diagnosis of type 2 diabetes
- Insomnia Severity Index >10 and self-reported symptoms of insomnia at least 3 nights/week for the past 3 months for insomnia and type 2 diabetes group
- Insomnia Severity Index ≤10 for type 2 diabetes only group
- Able to attend 6 sessions
- Able to understand and follow verbal commands in English
- Able to travel to our lab
Exclusion Criteria:
- Self-reported neurological diseases (e.g. Alzheimer's disease, Parkinson's disease, Traumatic Brain Injury, Stroke, Multiple Sclerosis)
- Stop-Bang > 4 indicating severe risk of sleep apnea
- Failure to pass Restless Leg Syndrome Diagnostic Index
- Severe pain ≥ 7 out of 10 on Brief Pain Inventory
- Severe symptom level of depression scores ≥ 21 on Beck Depression Inventory
- Severe symptom level of anxiety scores ≥ 15 on Generalized Anxiety Scale-7
- Pregnant women
- Self-reported following medical issues: Chronic Fatigue Syndrome, Fibromyalgia, and Rheumatic Diseases
- Speech deficits or significant auditory impairment
- Night-shift work
- Self-reported Bipolar and Seizure Disorders
- Heavy alcohol drinker (≥15 drinks per week for men and ≥ 8 drinks per week for women)
- Dialysis/blindness/trans-femoral amputation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: CBT-I intervention
The intervention includes several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components.
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CBT-I is designed to change sleep habits as well as direct misconceptions about sleep and insomnia.
Participants will receive several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components.
The intervention will be provided in 6-session (one session/week).
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활성 비교기: Diabetes Education
Sleep hygiene, foot care, causes and diagnosis of diabetes, healthy diet, and physical activity will be delivered for the Health Education group.
During all sessions, subjects will be encouraged to engage in the discussion through open questions about their experience in diabetes, lifestyle, and understanding about provided materials.
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Participants in this arm will receive education in sleep hygiene, foot care, causes and diagnosis of diabetes, healthy diet, and physical activity.
The education will be provided in 6-session (1 session/week).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Insomnia Severity Index
기간: Insomnia severity will be assessed at the baseline and 8 weeks.
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The Insomnia Severity Index is a self-report measure designed to evaluate the nature, severity, and impact of insomnia.Seven-items assess severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress due to the sleep difficulties.This is self-reported seven items on a five-point Likert scale from zero (not at all satisfied) to four (very much satisfied).
Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
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Insomnia severity will be assessed at the baseline and 8 weeks.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in the Variability of Total Sleep Time in Minutes using Objective Measure, Actigraph
기간: The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
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Actigraph is a useful measure for common sleep parameters including total in minutes being awake, total sleep time, sleep latency, and sleep efficiency.
The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total sleep time (in minutes) divided by the mean of 7 nights of total sleep time (in minutes) multiply by 100).
The range of Total Sleep Time variability is from 0% to 100%, with higher score indicating higher variability of Total Sleep Time.
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The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
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Change in the Variability of Wake after Sleep Onset in Minutes using Objective Measure, Actigraph
기간: The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
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Actigraph is a useful measure for common sleep parameters including total in minutes being awake, total sleep time, sleep latency, and sleep efficiency.
The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total Wake after Sleep Onset (in minutes) divided by the mean of 7 nights of total Wake after Sleep Onset (in minutes) multiply by 100).
The range of Wake after Sleep Onset variability is from 0% to 100%, with higher score indicating higher variability of Wake after Sleep Onset.
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The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
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Change in the Variability of Sleep Latency in Minutes using Objective Measure, Actigraph
기간: The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
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Actigraph is a useful measure for common sleep parameters including total in minutes being awake, total sleep time, sleep latency, and sleep efficiency.
The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total sleep latency (in minutes) divided by the mean of 7 nights of total sleep latency (in minutes) multiply by 100).
The range of Sleep Latency variability is from 0% to 100%, with higher score indicating higher variability of Sleep Latency.
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The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
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Change in the Variability of Sleep Efficiency using Objective Measure, Actigraph
기간: The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
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Actigraph is a useful measure for common sleep parameters including total in minutes being awake, total sleep time, sleep latency, and sleep efficiency.
The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of sleep efficiency (in percentage) divided by the mean of 7 nights of sleep efficiency (in percentage) multiply by 100).
The range of Sleep Efficiency variability is from 0% to 100%, with higher score indicating higher variability of Sleep Efficiency.
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The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
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Change in the Variability of Total Sleep Time in Minutes using Subjective Measure, Sleep Diary
기간: The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
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Sleep diary is a subjective gold stander sleep measures.
Subjects will be asked to report their daily sleep including time in bed and out of bed, total sleep time, number of awakening and total time being awake.
The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total sleep time (in minutes) divided by the mean of 7 nights of total sleep time (in minutes) multiply by 100).
The range of Total Sleep Time variability is from 0% to 100%, with higher score indicating higher variability of Total Sleep Time.
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The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
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Change in the Variability of Wake after Sleep Onset in Minutes using Subjective Measure, Sleep Diary
기간: The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
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Sleep diary is a subjective gold stander sleep measures.
Subjects will be asked to report their daily sleep including time in bed and out of bed, total sleep time, number of awakening and total time being awake.
The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total Wake after Sleep Onset (in minutes) divided by the mean of 7 nights of total Wake after Sleep Onset (in minutes) multiply by 100).
The range of Wake after Sleep Onset variability is from 0% to 100%, with higher score indicating higher variability of Wake after Sleep Onset.
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The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
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Change in the Variability of Sleep Latency in Minutes using Subjective Measure, Sleep Diary
기간: The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
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Sleep diary is a subjective gold stander sleep measures.
Subjects will be asked to report their daily sleep including time in bed and out of bed, total sleep time, number of awakening and total time being awake.
The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of total sleep latency (in minutes) divided by the mean of 7 nights of total sleep latency (in minutes) multiply by 100).
The range of Sleep Latency variability is from 0% to 100%, with higher score indicating higher variability of Sleep Latency.
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The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
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Change in the Variability of Sleep Efficiency using Subjective Measure, Sleep Diary
기간: The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
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Sleep diary is a subjective gold stander sleep measures.
Subjects will be asked to report their daily sleep including time in bed and out of bed, total sleep time, number of awakening and total time being awake.
Sleep efficiency will be calculated based on the ratio of total sleep time and total time in bed multiply by 100.
The variability of 7 nights will be measured by Coefficient of Variance (standard deviation of 7-nights of sleep efficiency (in percentage) divided by the mean of 7 nights of sleep efficiency (in percentage) multiply by 100).
The range of Sleep Efficiency variability is from 0% to 100%, with higher score indicating higher variability of Sleep Efficiency.
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The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
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Change in Fatigue Severity Scale Total Score
기간: Fatigue severity will be assessed at the baseline and 8 weeks.
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Fatigue Severity Scale is a validated 9-item questionnaire, to assess the fatigue in daily life and differentiate between fatigue and clinical depression.
Total scores in which < 4 indicate no fatigue, scores between 4 and 4.9 indicate moderate fatigue, and score >5 indicate severe fatigue.
The mean score of the nine items will be used, which ranges from 1 to 7.
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Fatigue severity will be assessed at the baseline and 8 weeks.
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Change in Diabetes Self-Care Behavior using Diabetes Care Profile
기간: Change in each sub-scale on the Diabetes Care Profile from the baseline and at 8 weeks
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Diabetes care profile is a validated instrument that measures self-reported diabetes control, psychological and social factors including Control Problems, Social and Personal Factors, Negative Attitude, Positive Attitude, Self-Care Adherence, and Diet Adherence.
Each item on the Diabetes Care Profile is rated on 1 to 5 scales to evaluate the frequency of symptoms.
Control Problems, Social and Personal Factors, and Negative Attitude are rated on a scale where 1 is good and 5 is poor; Positive Attitude, Self-Care Adherence, and Diet Adherence are rated on a scale where 5 is good and 1 is poor.
Each sub-scale will represent an aspect in the diabetes self-care behavior.
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Change in each sub-scale on the Diabetes Care Profile from the baseline and at 8 weeks
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Change in Glycemic Control Level
기간: A1C will be assessed at the baseline and 8 weeks.
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Glycemic control will be tested using HbA1c testing Kit.
HbA1c indicates the average blood glucose level of people with diabetes over the previous 2-3 months.
Higher score on the A1C indicates poor glycemic control
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A1C will be assessed at the baseline and 8 weeks.
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Change in Epworth Daytime Sleepiness Scale Total Score
기간: Daytime sleepiness will be assessed at the baseline and 8 weeks.
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The Epworth Sleepiness Scale will be utilized to evaluate the daytime sleepiness and subjectively investigate the likelihood of unintentionally falling asleep or increased difficulty in staying awake .
It encompasses 8 items where the subjects rate how likely they would be to fall asleep in 8 different states of daily activities.
A 4-point Likert scale ranging between 0 "never doze" and 3 "high chance of dozing".
Total score will be used, which ranges from 0 to 24.
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Daytime sleepiness will be assessed at the baseline and 8 weeks.
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Change in The Pittsburgh Sleep Quality Index Global Score
기간: Sleep quality will be assessed at the baseline and 8 weeks.
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The Pittsburgh Sleep Quality Index is a validated 19-item questionnaire, and it differentiates between poor sleepers and good sleepers.
it is derived from 7 items including perceived sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
These items are separately scored from 0-3, with 3 representing the negative extreme, and summed to provide a global score.
The total score of Pittsburgh Sleep Quality Index will be used, which ranges from 0 to 21.
Higher scores indicate poor sleep quality.
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Sleep quality will be assessed at the baseline and 8 weeks.
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Change in Random Glucose Level
기간: Random glucose level will be assessed at the baseline and 8 weeks.
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Glucose meter will be utilized to assess the glucose level.
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Random glucose level will be assessed at the baseline and 8 weeks.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Alshehri MM, Alothman SA, Alenazi AM, Rucker JL, Phadnis MA, Miles JM, Siengsukon CF, Kluding PM. The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes. BMC Endocr Disord. 2020 Sep 5;20(1):136. doi: 10.1186/s12902-020-00612-6.
- Alshehri MM, Alenazi AM, Hoover JC, Alothman SA, Phadnis MA, Rucker JL, Befort CA, Miles JM, Kluding PM, Siengsukon CF. Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 19;8(12):e14647. doi: 10.2196/14647.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 1월 16일
기본 완료 (실제)
2019년 6월 1일
연구 완료 (실제)
2019년 6월 1일
연구 등록 날짜
최초 제출
2018년 10월 11일
QC 기준을 충족하는 최초 제출
2018년 10월 18일
처음 게시됨 (실제)
2018년 10월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 8월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 8월 26일
마지막으로 확인됨
2019년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00142985
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The protocol of this study will be published.
We already submit the protocol to an Open access journal.
IPD 공유 기간
The protocol will be submitted to an open access journal and will be available to everyone.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Cognitive behavioral therapy for insomnia에 대한 임상 시험
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