Clinical trial NCT06025968: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Insomnia
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Sleep diary - Total Wake Time (TWT)
timeFrame: Baseline, daily through study completion, up to 8 weeks
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 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.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 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.
measure: The Generalized Anxiety Disorder (GAD-7)
timeFrame: 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.
measure: Fatigue Severity Scale (FSS)
timeFrame: 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.
measure: The Brunnsviken Brief Quality of Life Scale (BBQ)
timeFrame: 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.
measure: Negative effects
timeFrame: After the intervention.
measure: Sleep diary- Sleep onset latensy (SOL)
timeFrame: Baseline, daily through study completion, up to 8 weeks
measure: Sleep diary- wake after sleep onset (WASO)
timeFrame: Baseline, daily through study completion, up to 8 weeks
measure: Sleep diary. early morning awakening (EMA)
timeFrame: Baseline, daily through study completion, up to 8 weeks
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 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.
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: After the treatment that is 6 to 8 weeks after entering the treatment
Other outcomes:
measure: The severity of MS - MS check
timeFrame: Screening
measure: The Credibility/Expectancy Questionnaire
timeFrame: Will be administered after the first treament week.
Locations:
city: Uppsala
country: Sweden
facility: Department of Psychology, Uppsala University
state: Uppland
Study officials:
affiliation: Uppsala University
name: Monica Buhrman, phd
role: PRINCIPAL_INVESTIGATOR
References: