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The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes.

ABSTRACT: BACKGROUND:Previous studies have shown the negative impact of sleep disturbances, specifically insomnia symptoms, on glucose metabolism for people with type 2 diabetes (T2D). People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB). Investigating the impact of a safe and effective intervention for individuals with T2D and insomnia symptoms on diabetes' health outcomes is needed. Therefore, the aim of this exploratory study is to examine the effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) on glycemic control, DSCB, and fatigue. METHODS:Twenty-eight participants with T2D and insomnia symptoms, after passing an eligibility criteria at a medical research center, were randomly assigned to CBT-I (n?=?14) or Health Education (HE; n?=?14). The CBT-I and HE groups received 6 weekly one-hour sessions. This Randomized Controlled Trial (RCT) used a non-inferiority framework to test the effectiveness of CBT-I. Validated assessments were administered at baseline and post-intervention to assess glycemic control, DSCB, and fatigue. A Wilcoxon signed-rank test was utilized to compare within-group changes from baseline to post-intervention. A Mann-Whitney test was utilized to measure the between-group differences. Linear regression was used to assess the association between the blood glucose level and the number of days in the CBT-I group. RESULTS:The recruitment duration was from October 2018 to May 2019. A total of 13 participants completed the interventions in each group and are included in the final analysis. No adverse events, because of being a part of this RCT, were reported. CBT-I participants showed significantly greater improvement in glycemic control, DSCB, and fatigue. There was a significant association between the number of days in the CBT-I intervention with the blood glucose level before bedtime (B?=?-0.56, p?=?.009) and after awakening in the morning (B?=?-0.57, p?=?.007). CONCLUSIONS:This study demonstrated a clinically meaningful effect of CBT-I on glycemic control in people with T2D and insomnia symptoms. Also, CBT-I positively impacted daytime functioning, including DSCB and fatigue. Future research is needed to investigate the long-term effects of CBT-I on laboratory tests of glycemic control and to understand the underlying mechanisms of any improvements. TRIAL REGISTRATION:Clinical Trials Registry ( NCT03713996 ). Retrospectively registered on 22 October 2018.

SUBMITTER: Alshehri MM

PROVIDER: S-EPMC7487570 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes.

Alshehri Mohammed M MM Alothman Shaima A SA Alenazi Aqeel M AM Rucker Jason L JL Phadnis Milind A MA Miles John M JM Siengsukon Catherine F CF Kluding Patricia M PM

BMC endocrine disorders 20200905 1

<h4>Background</h4>Previous studies have shown the negative impact of sleep disturbances, specifically insomnia symptoms, on glucose metabolism for people with type 2 diabetes (T2D). People with insomnia symptoms are at risk of poor glycemic control and suboptimal diabetes self-care behavior (DSCB). Investigating the impact of a safe and effective intervention for individuals with T2D and insomnia symptoms on diabetes' health outcomes is needed. Therefore, the aim of this exploratory study is to ...[more]

PMID: 32891140

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Project description:BackgroundInsomnia symptoms are a common form of sleep difficulty among people with type 2 diabetes (T2D) affecting sleep quality and health outcomes. Several interventional approaches have been used to improve sleep outcomes in people with T2D. Nonpharmacological approaches, such as cognitive behavioral therapy for insomnia (CBT-I), show promising results regarding safety and sustainability of improvements, although CBT-I has not been examined in people with T2D. Promoting sleep for people with insomnia and T2D could improve insomnia severity and diabetes outcomes.ObjectiveThe objective of this study is to establish a protocol for a pilot randomized controlled trial (RCT) to examine the effect of 6 sessions of CBT-I on insomnia severity (primary outcome), sleep variability, and other health-related outcomes in individuals with T2D and insomnia symptoms.MethodsThis RCT will use random mixed block size randomization with stratification to assign 28 participants with T2D and insomnia symptoms to either a CBT-I group or a health education group. Outcomes including insomnia severity; sleep variability; diabetes self-care behavior (DSCB); glycemic control (A1c); glucose level; sleep quality; daytime sleepiness; and symptoms of depression, anxiety, and pain will be gathered before and after the 6-week intervention. Chi-square and independent t tests will be used to test for between-group differences at baseline. Independent t tests will be used to examine the effect of the CBT-I intervention on change score means for insomnia severity, sleep variability, DSCB, A1c, fatigue, sleep quality, daytime sleepiness, and severity of depression, anxiety, and pain. For all analyses, alpha level will be set at .05.ResultsThis study recruitment began in February 2019 and was completed in September 2019.ConclusionsThe intervention, including 6 sessions of CBT-I, will provide insight about its effect in improving insomnia symptoms, sleep variability, fatigue, and diabetes-related health outcomes in people with T2D and those with insomnia symptoms when compared with control.Trial registrationClinicalTrials.gov NCT03713996; https://clinicaltrials.gov/ct2/show/NCT03713996.International registered report identifier (irrid)DERR1-10.2196/14647.

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The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes.

Publications

The effects of cognitive behavioral therapy for insomnia in people with type 2 diabetes mellitus, pilot RCT part II: diabetes health outcomes.

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