Digital Cognitive-behavioral Therapy for Insomnia for Patients With Mu
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis: A Randomised Controlled Trial
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- i-CBT
Compared with
- Applied relaxation
What it measured
Main measures
Sleep diary - Total Wake Time (TWT)
Baseline, daily through study completion, up to 8 weeks
Mood and sleep
Other measures (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.
Mood and sleepPatient 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.
Mood and sleepThe 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.
Mood and sleepFatigue 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.
FatigueThe 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.
Quality of life (reported by participants)Negative effects
After the intervention.
FatigueMood and sleepSleep diary- Sleep onset latensy (SOL)
Baseline, daily through study completion, up to 8 weeks
Mood and sleepSleep diary- wake after sleep onset (WASO)
Baseline, daily through study completion, up to 8 weeks
Mood and sleepSleep diary. early morning awakening (EMA)
Baseline, daily through study completion, up to 8 weeks
Mood and sleepMultiple Sclerosis Impact Scale (MSIS-29)
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.
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Sept 2023
Main results due
Jan 2024
Finished
Sept 2025