Dataset Information

Feasibility and Treatment Effect of a Web-Based Cognitive Behavioral Therapy for Insomnia Program in Individuals with Multiple Sclerosis: A Pilot Randomized Controlled Trial.

ABSTRACT:

Background

At least 40% of individuals with multiple sclerosis (MS) experience chronic insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia symptoms in individuals with MS. Delivery of CBT-I using Web-based applications has been shown to be effective and may increase access to CBT-I for individuals with MS who have mobility difficulties, experience fatigue, or live in rural areas. Therefore, the purpose of this study was to assess the feasibility and treatment effect of CBT-I delivered using a Web-based application with or without biweekly telephone calls to improve sleep quality and fatigue in individuals with MS and symptoms of insomnia.

Methods

Forty-one individuals with MS and symptoms of insomnia were randomized into either a group that participated in a 6-week Web-based CBT-I program (wCBT-I) or a group that participated in a 6-week Web-based CBT-I program and received biweekly support telephone calls (wCBT-I + calls). Participants completed surveys online to assess insomnia severity, sleep quality, fatigue, sleep self-efficacy, depression, anxiety, and motivation to change their sleep behavior.

Results

The overall retention rate was 48.8%, and the adherence rate was 96.34%. Both groups had significant improvement in insomnia severity, sleep quality, sleep self-efficacy, and anxiety. Only the wCBT-I group had significant improvement in depression and fatigue.

Conclusions

Web-delivered CBT-I is feasible and effective in improving sleep outcomes and concomitant symptoms in individuals with MS. Web-based CBT-I may increase access to CBT-I treatment and provide a stepped-care approach to treating chronic insomnia in individuals with MS.

SUBMITTER: Siengsukon CF

PROVIDER: S-EPMC8218587 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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: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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