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

NCT06025968 | Unknown

• 1 other identifier: Uppsala univerisity
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis; Insomnia

Outcome Measures

Primary Outcomes (1)

• Sleep diary - Total Wake Time (TWT)

  Total wake time (TWT) is calculated by summing the variables Sleep onset latensy, Wake after slepp onset and Early morning awakening in minutes from the sleep diary. This measure has been used as an outcome measure in clinical studies of CBT-I because it may have better explanatory power than other variables in the sleep diary. .

  Baseline, daily through study completion, up to 8 weeks

Secondary Outcomes (11)

• Insomnia Severity Index (ISI)

  Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment, and 6 and 12 months after the treatment.

• Patient Health Questionnaire (PHQ-9)

  Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.s.

• The Generalized Anxiety Disorder (GAD-7)

  Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.

• Fatigue Severity Scale (FSS)

  Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.

• The Brunnsviken Brief Quality of Life Scale (BBQ)

  Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment, and 6 and 12 months after the treatment.

Other Outcomes (2)

• The severity of MS - MS check

  Screening

• The Credibility/Expectancy Questionnaire

  Will be administered after the first treament week.

Study Arms (2)

i-CBT

EXPERIMENTAL

Cognitive behavioral therapy for insomnia with adjustment for MS.

Behavioral: i-CBT

Applied relaxation

ACTIVE COMPARATOR

Applied relaxation with adjustments for MS.

Behavioral: Applied relaxation

Interventions

i-CBT 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..

i-CBT

Applied relaxation 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.

Applied relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of Psychology, Uppsala University

Uppsala, Uppland, 75236, Sweden

Location

MeSH Terms

Conditions

Multiple Sclerosis; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Monica Buhrman, phd

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Buhrman, phd

CONTACT

+46733468539; Monica.Buhrman@psyk.uu.se

Markus Jansson Fröjmark, phd

CONTACT

markus.jansson-frojmark@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be adiministered via a digital platform.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

SE (1)