Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT06025968
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
Study:
NCT06025968
Study Brief:
Protocol Section:
NCT06025968