Type2 DiabetesNCT03713996
The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes
A study testing Cognitive behavioral therapy for insomnia and Health Education in people with Type2 Diabetes and Insomnia, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type2 Diabetes, Insomnia
- What is being tested?
- Cognitive behavioral therapy for insomnia and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 1 Jun 2019
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Type2 Diabetes, Insomnia
- Being tested
- Cognitive behavioral therapy for insomnia, Health Education
- Keywords
- Cognitive Behavioral Therapy for Insomnia, Self-Care, Fatigue, Diabetes, Glycemic Control
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for insomniaBehavioural
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).
Health EducationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| CBT-I intervention | Experimental | The intervention includes several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components. Receives: Behavioral: Cognitive behavioral therapy for insomnia |
| Diabetes Education | Active comparator | 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. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index
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.
Measured: Insomnia severity will be assessed at the baseline and 8 weeks.
Secondary outcomes (14)
Change in the Variability of Total Sleep Time in Minutes using Objective Measure, Actigraph
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.
Measured: The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Wake after Sleep Onset in Minutes using Objective Measure, Actigraph
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.
Measured: The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Sleep Latency in Minutes using Objective Measure, Actigraph
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.
Measured: The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Sleep Efficiency using Objective Measure, Actigraph
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.
Measured: The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Total Sleep Time in Minutes using Subjective Measure, Sleep Diary
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.
Measured: The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Wake after Sleep Onset in Minutes using Subjective Measure, Sleep Diary
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.
Measured: The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Sleep Latency in Minutes using Subjective Measure, Sleep Diary
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.
Measured: The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Sleep Efficiency using Subjective Measure, Sleep Diary
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.
Measured: The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
Change in Fatigue Severity Scale Total Score
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.
Measured: Fatigue severity will be assessed at the baseline and 8 weeks.
Change in Diabetes Self-Care Behavior using Diabetes Care Profile
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.
Measured: Change in each sub-scale on the Diabetes Care Profile from the baseline and at 8 weeks
Change in Glycemic Control Level
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
Measured: A1C will be assessed at the baseline and 8 weeks.
Change in Epworth Daytime Sleepiness Scale Total Score
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.
Measured: Daytime sleepiness will be assessed at the baseline and 8 weeks.
Change in The Pittsburgh Sleep Quality Index Global Score
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.
Measured: Sleep quality will be assessed at the baseline and 8 weeks.
Change in Random Glucose Level
Glucose meter will be utilized to assess the glucose level.
Measured: Random glucose level will be assessed at the baseline and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start16 Jan 2019
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Kluding, PhD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713996
- Sponsor's protocol ID
- STUDY00142985
- Status last verified
- Aug 2019
- First submitted
- 11 Oct 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol of this study will be published. We already submit the protocol to an Open access journal.
Publications
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.
PubMed 32891140Alshehri 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.
PubMed 31855189
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia and Type 2 Diabetes: Measurement, Impact and Intervention
- ClinicalTrials.gov ID
- NCT03713996
- Acronym / sponsor ID
- STUDY00142985
- Conditions
- Type2 Diabetes, Insomnia
- Keywords
- Cognitive Behavioral Therapy for Insomnia, Self-Care, Fatigue, Diabetes, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 22 Oct 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I intervention | Experimental | Behavioral: Cognitive behavioral therapy for insomniaThe intervention includes several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components. |
| Diabetes Education | Active comparator | Other: Health EducationSleep 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 therapy for insomniaCBT-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). | Behavioural | CBT-I intervention |
| Health EducationParticipants 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). | Other | Diabetes Education |
Primary outcome
Change in Insomnia Severity Index
Time frame: Insomnia severity will be assessed at the baseline and 8 weeks.
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.
14 secondary outcomes
Change in the Variability of Total Sleep Time in Minutes using Objective Measure, Actigraph
Time frame: The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Wake after Sleep Onset in Minutes using Objective Measure, Actigraph
Time frame: The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Sleep Latency in Minutes using Objective Measure, Actigraph
Time frame: The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Sleep Efficiency using Objective Measure, Actigraph
Time frame: The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Total Sleep Time in Minutes using Subjective Measure, Sleep Diary
Time frame: The variability of total sleep time for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Wake after Sleep Onset in Minutes using Subjective Measure, Sleep Diary
Time frame: The variability of wake after sleep onset for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Sleep Latency in Minutes using Subjective Measure, Sleep Diary
Time frame: The variability of sleep latency for 7 nights will be assessed at the baseline and 8 weeks.
Change in the Variability of Sleep Efficiency using Subjective Measure, Sleep Diary
Time frame: The variability of sleep efficiency for 7 nights will be assessed at the baseline and 8 weeks.
Change in Fatigue Severity Scale Total Score
Time frame: Fatigue severity will be assessed at the baseline and 8 weeks.
Change in Diabetes Self-Care Behavior using Diabetes Care Profile
Time frame: Change in each sub-scale on the Diabetes Care Profile from the baseline and at 8 weeks
Change in Glycemic Control Level
Time frame: A1C will be assessed at the baseline and 8 weeks.
Change in Epworth Daytime Sleepiness Scale Total Score
Time frame: Daytime sleepiness will be assessed at the baseline and 8 weeks.
Change in The Pittsburgh Sleep Quality Index Global Score
Time frame: Sleep quality will be assessed at the baseline and 8 weeks.
Change in Random Glucose Level
Time frame: Random glucose level will be assessed at the baseline and 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 32891140Alshehri 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.
- Derived from this study: PubMed 31855189Alshehri 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.
- Individual participant dataSharing planned: Yes. The protocol of this study will be published. We already submit the protocol to an Open access journal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for insomnia and Health Education in people with Type2 Diabetes and Insomnia, run by University of Kansas Medical Center at 1 site in United States.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (time frame: Insomnia severity will be assessed at the baseline and 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713996, which also lists 2 linked publications.
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 2019.