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

CompletedNot a drug-phase studyMS (type not specified)NCT03216889

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Cognitive Behavioral Therapy for Insomnia

Compared with

  • Control

What it measured

Main measures

  • Insomnia Severity Index (ISI)

    Change from Baseline to Week 7

    Mood and sleep

Other measures (4)

  • Pittsburgh Sleep Quality Index (PSQI)

    Change from Baseline to Week 7

    Mood and sleep
  • Modified Fatigue Impact Scale (MFIS)

    Change from Baseline to Week 7

    Thinking and memoryFatigue
  • Fatigue Severity Scale (FSS)

    Change from Baseline to Week 7

    Fatigue
  • Multiple Sclerosis Impact Scale (MSIS)

    Change from Baseline to Week 7

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 80

Show the full criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jun 2017

    2. Main results due

      Aug 2019

    3. Finished

      Aug 2019

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