Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT06025968
Status:
UNKNOWN
Last Update Posted:
2023-09-06
First Post:
2023-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
Sponsor:
Uppsala University
Organization:
Study Overview
Official Title:
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis: A Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: