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Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis

NCT06025968 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2023-09-06

No results posted yet for this study

Summary

The goal of this clinical trialis to compare a digital Cognitive-behavioral intervention for insomnia to digital administered applied relaxation in participants with Multiple Sclerosis.

The treatments will be compared in following outcomes:

* Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and early morning awakening (EMA).
* Insomnia symptoms
* Depressive symptoms
* Client satisfaction
* Negative effects
* Worry
* Fatigue
* Quality of life
* MS symptoms/function

Conditions

Interventions

BEHAVIORAL

i-CBT

The content is based on manual by Perlis et al (2015) and has slightly reworked by the research team by shortening treatment from seven to six sessions and allowing for day-time naps that may be necessary for patient with MS (Siengsukon et al. 2020). Due to the high prevalence of fatigue in people with MS, naps during the day may be a necessity to cope with everyday tasks. In cases where patients could not refrain from naps, they were advised to limit them to maximum 20 minutes and to take them as early in the day as possible. Other components are sleep restriction, sleep hygiene, stimulus control and cognitive techniques..

BEHAVIORAL

Applied relaxation

Treatment consits of 6 modules. The main components in the training program will be progressive muscle relaxation, short relaxation with release only and without tension, and finally the participants will be taught rapid relaxation.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Monica Buhrman, phd · Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-01-31
Completion
2025-09-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06025968 on ClinicalTrials.gov