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Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Insomnia 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. OBJECTIVE:The 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. METHODS:This 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. RESULTS:This study recruitment began in February 2019 and was completed in September 2019. CONCLUSIONS:The 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 REGISTRATION:ClinicalTrials.gov NCT03713996; https://clinicaltrials.gov/ct2/show/NCT03713996. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14647.

SUBMITTER: Alshehri MM

PROVIDER: S-EPMC6940863 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

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

JMIR research protocols 20191219 12

<h4>Background</h4>Insomnia 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 pe ...[more]

PMID: 31855189

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Project description:BackgroundAt least 40% of individuals with multiple sclerosis (MS) exercise chronic insomnia, and the prevalence is likely higher due to underdiagnosis. Poor sleep quality has been associated with increased fatigue, anxiety, depression, and risk of relapse in individuals with MS. While cognitive behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, the treatment effect of CBT-I in people with MS is unclear.ObjectiveThis pilot randomized control trial (RCT) assessed the feasibility and treatment effect of CBT-I to improve sleep quality and fatigue in individuals with MS with symptoms of insomnia.MethodsThirty-three individuals with MS (30 females, 3 males; 30 relapsing-remitting; 3 secondary-progressive; 53.0 ± 9.4 years old) with symptoms of insomnia were randomized into one of three arms: 1. 6-week CBT-I program, 2. 6-week active control, or 3. Single session of sleep education. Participants completed surveys to assess sleep quality, fatigue, sleep self-efficacy, depression, and anxiety.ResultsCBT-I in individuals with MS is feasible with high retention and adherence rate. All groups experienced a large magnitude of improvement in insomnia symptoms. The CBT-I and brief education groups experienced a large magnitude of improvement in sleep quality and fatigue. Only the CBT-I group demonstrated a large magnitude of improvement in sleep self-efficacy and depression.ConclusionThis is the first study to prospectively demonstrates that CBT-I is feasible in people with MS and produces promising improvements in insomnia severity, sleep quality, sleep self-efficacy and comorbid symptoms of fatigue, depression, and anxiety. Future studies are needed to determine mechanisms for these improvements and expand the scope of individuals with MS who may benefit from CBT-I. Furthermore, considering the moderate to large improvements experienced by the brief education group and the limited number of CBT-I providers, a stepped-care approach warrants consideration.

Project description:Abstract:Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection (n?=?10). Phase II will be an RCT powered to examine preliminary intervention efficacy (n?=?30 per group). Participants for this study must meet criteria for "moderate to severe" insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time. Trial registration:NCT#03493958; registered 1 June 2018.

Project description:ObjectiveTo evaluate the effectiveness of cognitive behavioral therapy for insomnia during pregnancy.MethodsRandomized, unmasked, 3-site controlled trial. Participants were randomly allocated to cognitive behavioral therapy for insomnia (a first-line, empirically supported psychosocial intervention that addresses sleep-related behaviors and cognitions) or a control intervention consisting of imagery exercises that paired patient-identified distressing nighttime experiences with patient-identified neutral images. Participants were eligible if they met diagnostic criteria for insomnia disorder and were between 18 and 32 weeks of gestation. Patients were ineligible if they met diagnostic criteria for major psychiatric disorders, including depression, or were receiving nonstudy treatments that could affect sleep (or both). The primary outcome was the Insomnia Severity Index score, a validated brief questionnaire, with scores between 14 and 21 representing clinically meaningful insomnia of moderate severity, scores higher than 21 representing severe insomnia, and scores less than 8 representing no insomnia. Secondary outcomes included remission of insomnia (Insomnia Severity Index score less than 8), objectively measured and self-reported time awake (ie, total wake time), and the Edinburgh Postnatal Depression Scale score. All outcomes were measured weekly. Analysis included 48 participants who did not complete treatment. We estimated that 184 women would be required to have 80% power, with a two-tailed test, to detect a moderate Cohen's d effect size (.5) with α=.05.ResultsBetween May 2013 and April 2017, 194 pregnant women were randomized and 149 completed treatment; 179 with available baseline data (92%) were ultimately analyzed, 89 in the cognitive therapy group and 90 in the control group. Women assigned to cognitive behavioral therapy for insomnia experienced significantly greater reductions in insomnia severity (scores decreased from 15.4±4.3 to 8.0±5.2 in the cognitive behavioral therapy group vs from 15.9±4.4 to 11.2±4.9 in the control therapy group [P<.001, d=0.5]). Remission of insomnia (to an Insomnia Severity Index score less than 8) disorder was attained by 64% of women in the cognitive behavioral therapy for insomnia group vs 52% in the control group. Women receiving cognitive behavioral therapy for insomnia experienced faster remission of insomnia disorder, with a median of 31 days vs 48 days in the control therapy (P<.001). Cognitive behavioral therapy for insomnia led to significantly greater reduction in self-reported but not objective total wake time and a small but significantly greater decline in Edinburgh Postnatal Depression Scale scores vs the control group.ConclusionCognitive behavioral therapy for insomnia is an effective nonpharmacologic treatment for insomnia during pregnancy.Clinical trial registrationClinicalTrials.gov, NCT01846585.

Dataset Information

Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

Publications

Effect of Cognitive Behavioral Therapy for Insomnia on Insomnia Symptoms for Individuals With Type 2 Diabetes: Protocol for a Pilot Randomized Controlled Trial.

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