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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Multiple Sclerosis, Insomnia

Intervention / Treatment
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* Behavioral: i-CBT
* Behavioral: Applied relaxation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-CBT<br>Cognitive behavioral therapy for insomnia with adjustment for MS. | Behavioral: i-CBT<br>* 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..<br>|
| Active Comparator: Applied relaxation<br>Applied relaxation with adjustments for MS. | Behavioral: Applied relaxation<br>* 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.<br>|

What is the study measuring?
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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 |