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 postintervention 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).

Sleep disorders in people with type 2 diabetes and associated health outcomes: a review of the literature

“…An elegant meta-analysis by Kothari et al [ 44 ] identified six studies showing that cognitive behavioural therapy for insomnia (CBT-I) and/or sleep education improved sleep quality measured by the Pittsburgh Sleep Quality Index (−1.31 [95% CI −1.83, −0.80]) and resulted in a non-significant HbA 1c reduction (−3.6 mmol/mol [−0.35%]; p = 0.13) in those with sleep disturbances or insomnia, including both the general population and people with type 2 diabetes. Only two small pilot studies on CBT-I in people with type 2 diabetes have been conducted, reporting a reduction in both HbA 1c levels after 3 weeks (2.8 ± 3.06 mmol/mol [0.26 ± 0.28%]) [ 63 ] and after 7 weeks (4.5 mmol/mol [0.41%]; p = 0.01) [ 64 ], as well as a 4.63 ( p = 0.002) decrease in Beck Depression Inventory measures [ 65 ] in the latter cohort. The fact that CBT-I can effectively reduce depressive symptoms has been demonstrated previously outside this specific type 2 diabetes population [ 66 ].…”

“…These results suggest that weight loss, regardless of how the weight loss was induced, could be a successful treatment for OSA and type 2 diabetes. Only two small pilot studies on CBT-I in people with type 2 diabetes have been conducted, reporting a reduction in both HbA 1c levels after 3 weeks (2.8 ± 3.06 mmol/mol [0.26 ± 0.28%]) [63] and after 7 weeks (4.5 mmol/mol [0.41%]; p = 0.01) [64], as well as a 4.63 (p = 0.002) decrease in Beck Depression Inventory measures [65] in the latter cohort. The fact that CBT-I can effectively reduce depressive symptoms has been demonstrated previously outside this specific type 2 diabetes population [66].…”

Effectiveness of cognitive behavioral therapy-based interventions on health outcomes in patients with coronary heart disease: A meta-analysis

“…An increasing number of studies have applied CBT-based interventions to manage chronic pain[ 48 ], hypertension[ 49 ], diabetes[ 50 ], and cancer[ 51 ] and have found CBT interventions have been effective in improving health outcomes in these patients. Similarly, our meta-analysis found a positive impact of CBT-based interventions on psychological and physiological factors and QOL in patients with CHD.…”

Assessing the causal role of sleep traits on glycated haemoglobin: a Mendelian randomization study

“…56 They could also be an overestimate as current (largely behavioural) interventions would be challenging to implement in all people who have insomnia “usually” and none of them are effective in all participants. 57 58 Basically we are not aware of anything that matches our hypothetical intervention in terms of being safe and effectively reducing frequent insomnia in everyone, but this exercise may help with the interpretation of the effect estimate magnitude.…”