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

NCT ID: NCT06025968

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-09-30

Brief 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

Detailed Description

In order to start evaluate the digital treatment format, this study will use a Randomized Controlled Trial design (RCT). Participants with MS and insomnia from a Neurology clinic in Sweden will be randomized to either Cognitive-behavioral intervention for insomnia (iCBT) or Applied relaxation (AR). The treatments will consits of six sessions and will be administered digitally. Psychologists will have contact with the participants via a secure video call platform.Follow-up data will be gathered at six and 12 months after the treatments.

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
• Worry
• Fatigue
• Quality of life
• MS symptoms/function
• Client satisfaction
• Negative effects

Conditions

Multiple Sclerosis; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

i-CBT

Cognitive behavioral therapy for insomnia with adjustment for MS.

Group Type: EXPERIMENTAL

i-CBT

Intervention Type: BEHAVIORAL

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..

Applied relaxation

Applied relaxation with adjustments for MS.

Group Type: ACTIVE_COMPARATOR

Applied relaxation

Intervention Type: BEHAVIORAL

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.

Interventions

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..

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• be medically assessed
• meet criteria for MS and insomnia disorder
• have access to the internet and a smart phone with internet access
• have good reading ability, and
• be over 18 years of age

Exclusion Criteria

• have a planned treatment that may prevent participation
• were involved in ongoing medical research that may prevent participation,
• do not have a command of the Swedish language
• have a more serious acute psychiatric and/or somatic condition which prevented participation; or benefit from the treatment
• have an increased risk of suicide to the extent that participation in study was considered inappropriate,
• suffers from other primary sleep disorders such as sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, or parasomnia
• have insomnia due to environmental factors such as shift work.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Monica Buhrman

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Buhrman, phd

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Department of Psychology, Uppsala University

Uppsala, Uppland, Sweden

Countries

Sweden

Central Contacts

Monica Buhrman, phd

Role: CONTACT

Monica.Buhrman@psyk.uu.se

+46733468539

Markus Jansson Fröjmark, phd

Role: CONTACT

markus.jansson-frojmark@ki.se

Other Identifiers

Uppsala univerisity

Identifier Type: -

Identifier Source: org_study_id