Efficacy of Cognitive Behavioral Therapy for Insomnia to Treat Insomnia Symptoms in Individuals With Multiple Sclerosis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Kansas Medical Center

About this trial

The incidence of insomnia is estimated to be as high as 90% in individuals with MS due to insomnia being underdiagnosed. Sleep disturbances in people with MS have been associated with reduced cognitive performance, physical function, psychological well-being, quality of life, and occupational function, as well as increased prevalence of fatigue, pain, depression, and anxiety. The objective of the proposed study is to determine the efficacy of cognitive behavioral therapy for insomnia (CBT-I) to improve insomnia symptoms (Aim 1) fatigue, and health-related quality of life (Aim 2) in individuals with multiple sclerosis compared to an active control group, and to determine the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 3).

Eligibility criteria

Qualifiers

18-65 years old

Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines20 and verified by their neurologist

Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale)

Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5

Disqualifiers

Known untreated sleep disorder (such as sleep apnea or restless legs syndrome)

>3 on STOP BANG indicating increased risk of sleep apnea

Restless legs syndrome as determined by RLS-Diagnosis Index

Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised

Trial design

Treatments tested in this trial

  • Cognitive behavioral therapy for insomnia
  • Sleep and lifestyle education

Treatment groups

70 Participants
are divided into 2 treatment groups