Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis

University of Kansas

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03216889

STUDY00140418

Details and patient eligibility

About

The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I) will improve sleep quality, fatigue, and quality of life in individuals with multiple sclerosis (MS) with symptoms of insomnia.

Enrollment: 43 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of MS by physician
• Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 6 months,
• ≥10 on Insomnia Severity Index
• English speaking
• Core at least 24 on the Mini-Mental State Exam (MMSE) to indicate reduced risk of dementia

Exclusion criteria

• Known untreated sleep disorder (such as sleep apnea or restless leg syndrome)
• >4 on STOP BANG indicating high risk of sleep apnea
• Increased risk of restless leg syndrome on Restless Legs Syndrome (RLS) Diagnosis Index
• Nervous system disorder other than MS
• Relapse and/or corticosteroid use in past 8 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

43 participants in 2 patient groups

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Experimental group

Description:

6 weeks of CBT-I.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia

Control

Active Comparator group

Description:

6 weeks of stretching and thinking games.

Treatment:

Behavioral: Control