Back to resultsDigital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Insomnia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
i-CBT
Applied relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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.
Sites / Locations
- Department of Psychology, Uppsala University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
i-CBT
Applied relaxation
Arm Description
Cognitive behavioral therapy for insomnia with adjustment for MS.
Applied relaxation with adjustments for MS.
Outcomes
Primary Outcome Measures
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. .
Secondary Outcome Measures
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.
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.
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.
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..
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.
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
Sleep diary- Sleep onset latensy (SOL)
It is measured in minutes and calculated. The participant will register this in the sleep diary.
Sleep diary- wake after sleep onset (WASO)
It is measured in minutes and calculated. The participant will register this in the sleep diary.
Sleep diary. early morning awakening (EMA)
It is measured in minutes and calculated. The participant will register this in the sleep diary.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06025968
Brief Title
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
Official Title
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Outcomes will be adiministered via a digital platform.
Allocation
Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
i-CBT
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy for insomnia with adjustment for MS.
Arm Title
Applied relaxation
Arm Type
Active Comparator
Arm Description
Applied relaxation with adjustments for MS.
Intervention Type
Behavioral
Intervention Name(s)
i-CBT
Intervention Description
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
Intervention Name(s)
Applied relaxation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep diary - Total Wake Time (TWT)
Description
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. .
Time Frame
Baseline, daily through study completion, up to 8 weeks
Secondary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
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.
Title
Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
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.
Title
The Generalized Anxiety Disorder (GAD-7)
Description
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.
Time Frame
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.
Title
Fatigue Severity Scale (FSS)
Description
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..
Time Frame
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.
Title
The Brunnsviken Brief Quality of Life Scale (BBQ)
Description
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.
Time Frame
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.
Title
Negative effects
Description
Negative effects of the treatment were assessed with a questionnaire comprising 12 items regarding common symptoms such as fatigue, dizziness, and negative mood
Time Frame
After the intervention.
Title
Sleep diary- Sleep onset latensy (SOL)
Description
It is measured in minutes and calculated. The participant will register this in the sleep diary.
Time Frame
Baseline, daily through study completion, up to 8 weeks
Title
Sleep diary- wake after sleep onset (WASO)
Description
It is measured in minutes and calculated. The participant will register this in the sleep diary.
Time Frame
Baseline, daily through study completion, up to 8 weeks
Title
Sleep diary. early morning awakening (EMA)
Description
It is measured in minutes and calculated. The participant will register this in the sleep diary.
Time Frame
Baseline, daily through study completion, up to 8 weeks
Title
Multiple Sclerosis Impact Scale (MSIS-29)
Description
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.
Time Frame
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.
Title
Client Satisfaction Questionnaire-8 (CSQ-8)
Description
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.
Time Frame
After the treatment that is 6 to 8 weeks after entering the treatment
Other Pre-specified Outcome Measures:
Title
The severity of MS - MS check
Description
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.
Time Frame
Screening
Title
The Credibility/Expectancy Questionnaire
Description
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.
Time Frame
Will be administered after the first treament week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Buhrman, phd
Phone
+46733468539
Email
Monica.Buhrman@psyk.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Jansson Fröjmark, phd
Email
markus.jansson-frojmark@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Buhrman, phd
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Uppsala University
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75236
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
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