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

Uppsala University

Status: Not yet enrolling

Conditions: Multiple Sclerosis; Insomnia

Treatments: Behavioral: i-CBT; Behavioral: Applied relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT06025968

Uppsala univerisity

Details and patient eligibility

About

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

Full 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

Enrollment: 69 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

i-CBT

Experimental group

Description:

Cognitive behavioral therapy for insomnia with adjustment for MS.

Treatment:

Behavioral: i-CBT

Applied relaxation

Active Comparator group

Description:

Applied relaxation with adjustments for MS.

Treatment:

Behavioral: Applied relaxation