Multiple SclerosisNCT06025968
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
A study testing i-CBT and Applied relaxation in people with Multiple Sclerosis and Insomnia, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Insomnia
- What is being tested?
- i-CBT and Applied relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Markus Jansson Fröjmark, phd contact
Sweden1 site
Department of Psychology, Uppsala University
Uppsala, Uppland, 75236
About this study
Official title: 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
Read the 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
- Being tested
- i-CBT, Applied relaxation
- Medical subject headings
- Multiple Sclerosis, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-CBTBehavioural
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 relaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| i-CBT | Experimental | Cognitive behavioral therapy for insomnia with adjustment for MS. Receives: Behavioral: i-CBT |
| Applied relaxation | Active comparator | Applied relaxation with adjustments for MS. Receives: Behavioral: Applied relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. .
Measured: Baseline, daily through study completion, up to 8 weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After the treatment that is 6 to 8 weeks after entering the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Buhrman, Uppsala University
- Investigators
- Monica Buhrman, phd, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025968
- Sponsor's protocol ID
- Uppsala univerisity
- Status last verified
- Sep 2023
- First submitted
- 20 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06025968
- Acronym / sponsor ID
- Uppsala univerisity
- Conditions
- Multiple Sclerosis, Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| i-CBT | Experimental | Behavioral: i-CBTCognitive behavioral therapy for insomnia with adjustment for MS. |
| Applied relaxation | Active comparator | Behavioral: Applied relaxationApplied relaxation with adjustments for MS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-CBTThe 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.. | Behavioural | i-CBT |
| Applied relaxationTreatment 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. | Behavioural | Applied relaxation |
Primary outcome
Sleep diary - Total Wake Time (TWT)
Time frame: Baseline, daily through study completion, up to 8 weeks
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. .
11 secondary outcomes
Insomnia Severity Index (ISI)
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.
Patient Health Questionnaire (PHQ-9)
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.
The Generalized Anxiety Disorder (GAD-7)
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.
Fatigue Severity Scale (FSS)
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.
The Brunnsviken Brief Quality of Life Scale (BBQ)
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.
Negative effects
Time frame: After the intervention.
Sleep diary- Sleep onset latensy (SOL)
Time frame: Baseline, daily through study completion, up to 8 weeks
Sleep diary- wake after sleep onset (WASO)
Time frame: Baseline, daily through study completion, up to 8 weeks
Sleep diary. early morning awakening (EMA)
Time frame: Baseline, daily through study completion, up to 8 weeks
Multiple Sclerosis Impact Scale (MSIS-29)
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.
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: After the treatment that is 6 to 8 weeks after entering the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Jansson Fröjmark, phd contact
Monica Buhrman, phd principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-CBT and Applied relaxation in people with Multiple Sclerosis and Insomnia, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica Buhrman, phd (+46733468539, Monica.Buhrman@psyk.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep diary - Total Wake Time (TWT) (time frame: Baseline, daily through study completion, up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.