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

Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis: A Randomised Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis; Insomnia
• Intervention / Treatment: Behavioral: i-CBT; Behavioral: Applied relaxation

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

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Buhrman, phd; Phone Number: +46733468539; Email: Monica.Buhrman@psyk.uu.se
• Study Contact Backup: Name: Markus Jansson Fröjmark, phd; Email: markus.jansson-frojmark@ki.se

Study Locations

• Sweden
  • Uppland
    • Uppsala, Uppland, Sweden, 75236
      • Department of Psychology, Uppsala University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: i-CBT; Cognitive behavioral therapy for insomnia with adjustment for MS.	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..
Active Comparator: Applied relaxation; Applied relaxation with adjustments for MS.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	Measures the severity of insomnia and consists of seven questions regarding the individual's experience of insomnia with response options on a five-point Likert scale from 0-4. HIgher values indicating more severe insomna.	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)	The PHQ-9 consists of nine questions designed according to diagnostic criteria for major depression in the DSM-5, as well as a question on level of functioning.Higher values indicating worse outcome.	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)	Questionnaire which is a seven-item, self-report anxiety questionnaire designed to assess feelings of anxiety and worrying (Spitzer 2006). Each item is scored on a Likert scale between 0 and 3 and totaled for a score of 0 to 21. Higher score indicating worse outcome.	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)	Consists of nine questions with response options on a seven-point Likert scale 1 - 7 (Krupp et al, 1989). The total score is divided by the number of questions to give a mean score between 1 - 7. The higher the score, the more severe the fatigue..	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)	The BBQ comprise twelve items corresponding to satisfaction and importance of six life areas (Leisure time, View on life, Creativity, Learning, Friends and Friendship, and View of self) and provides a total score between 0 and 96 with a higher score representing a higher level of quality of life.	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.
Negative effects	Negative effects of the treatment were assessed with a questionnaire comprising 12 items regarding common symptoms such as fatigue, dizziness, and negative mood	After the intervention.
Sleep diary- Sleep onset latensy (SOL)	It is measured in minutes and calculated. The participant will register this in the sleep diary.	Baseline, daily through study completion, up to 8 weeks
Sleep diary- wake after sleep onset (WASO)	It is measured in minutes and calculated. The participant will register this in the sleep diary.	Baseline, daily through study completion, up to 8 weeks
Sleep diary. early morning awakening (EMA)	It is measured in minutes and calculated. The participant will register this in the sleep diary.	Baseline, daily through study completion, up to 8 weeks
Multiple Sclerosis Impact Scale (MSIS-29)	The MSIS-29 measures physical and psychological impact of MS. Items on the MSIS-29 have a Likert scale format (range 1.00-5.00); higher scores indicate a greater degree of disability. Total score is derived by summing items and transforming them into a score out of 100; higher scores imply a greater degree of disability.	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.
Client Satisfaction Questionnaire-8 (CSQ-8)	It is a brief global measure of client satisfaction..The CSQ-8 comprises eight items regarding service satisfaction that are scored on a 4-point Likert scale and provides a total score between 8 and 32. Higher values indicating higher satisfaction.	After the treatment that is 6 to 8 weeks after entering the treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of MS - MS check	The MS check which is a self-assessment questionnaire consisting of 14 questions concerning fatigue, cognition, mood, vision, speech/communication, and other bodily functions scored on a scale from 0 to 3. Higher scores indicating more severe disability and symptoms related to MS.	Screening
The Credibility/Expectancy Questionnaire	The questionnaire contains 6 items rated on a 1-9 or a 0%-100% scale, depending upon the item. In the credibility factor the items explore: if the treatment appears logical; if the treatment appears useful; and if the treatment is reliable.	Will be administered after the first treament week.

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Monica Buhrman, phd, Uppsala University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 20, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Estimated): September 6, 2023

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Multiple Sclerosis; Sclerosis; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Uppsala univerisity

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No