Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341751
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-13
Brief Title:
Psychological Treatment for Persistent Fatigue
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Psychological Treatment for Persistent Fatigue a Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
This is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm Sweden who suffer from persistent and disabling fatigue
Detailed Description:
Previous research indicates that fatigue is a transdiagnostic symptom dimension rather than a disorder-specific pathofysiology Similar psychosocial mechanisms can contribute to the development and perpetuation of fatigue across medical conditions Cognitive and behavioral interventions targeting these perpetuating mechanisms have been found effective in reducing fatigue severity and functional impairment in a range of different fatigue-dominated diagnostic groups Based on these findings the investigators have developed a transdiagnostic intervention for primary care patients who suffer from persistent fatigue independent of primary diagnosis The treatment is a psychological intervention based on cognitive and behavioral principles that is administered over a period of 4-6 months Treatment material will be delivered via an online treatment platform and therapist support will be given both face-to-face and via written asynchronous text-messages in the online treatment platform
This initial feasibility study is non-randomized meaning that all included patients will recieve treatment
The project could provide feasibility of a transdiagnostic treatment for primary care patients with severe and persistent fatigue across medical conditions If the inclusion procedure the data-collection procedure and the treatment are feasible a larger randomized clinical trial RCT studying treatment effect is called for An adequately powered RCT could provide firm scientific support for a novel scalable and cost-effective way to deliver an evidence-based treatment for this large and currently under-treated patient group This would have a desirable impact on patients families healthcare units and society at large given that fatigue is associated with substantial suffering and work-disability and that treatment guidelines are currently lacking
This initial feasibility study is non-randomized meaning that all included patients will recieve treatment
The project could provide feasibility of a transdiagnostic treatment for primary care patients with severe and persistent fatigue across medical conditions If the inclusion procedure the data-collection procedure and the treatment are feasible a larger randomized clinical trial RCT studying treatment effect is called for An adequately powered RCT could provide firm scientific support for a novel scalable and cost-effective way to deliver an evidence-based treatment for this large and currently under-treated patient group This would have a desirable impact on patients families healthcare units and society at large given that fatigue is associated with substantial suffering and work-disability and that treatment guidelines are currently lacking
Study Oversight
Has Oversight DMC:
None
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?:
None