Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 8:50 AM
Study NCT ID:
NCT05225012
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
Sponsor:
University of Nottingham
Organization:
Study Overview
Official Title:
Providing Emotional Support Around the Point of Multiple Sclerosis Diagnosis: PrEliMS 2
Status:
COMPLETED
Status Verified Date:
2024-11
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:
PrEliMS2
Brief Summary:
Emotional support following Multiple Sclerosis (MS) diagnosis is not part of the current service provision. However, research has identified a need for this as poor adjustment to diagnosis has been linked to higher levels of psychological distress. A previous study, named 'Providing Emotional Support Around the Point of MS Diagnosis' (PrEliMS), explored how best to provide support. People with MS completed a self-help workbook, alongside receiving support from MS nurses. The workbook is based on a psychological therapy called Acceptance and Commitment Therapy and was developed through focus groups of people with MS, relevant stakeholders, and clinical expertise. In this study, issues were found with parts of the workbook content and delivery. Nurses found it difficult to facilitate this alongside their usual MS Nurse care and felt psychological distress was not within their remit.
In this study, the investigators will
* explore how effective the PrEliMS workbook is at reducing distress from MS diagnosis, when delivered by a Psychology Practitioner (Trainee Clinical Psychologist)
* compare delivery by a Psychology Practitioner with the data from the Nurse delivered PrEliMS trial to explore which is more effective
* explore experience of the PrEliMS-2 intervention and potential improvements.
The investigators will recruit between three and seven people from an MS clinic who have received an MS diagnosis in the last year and consent to taking part. Participants will meet with a Psychology Practitioner (over the phone or online) once a week for four weeks, alongside completing the workbook. The investigators will also ask participants to complete questionnaires to examine their levels of psychological distress. Interviews will then be conducted to get feedback for refining the workbook.
The overall study will last a year
In this study, the investigators will
* explore how effective the PrEliMS workbook is at reducing distress from MS diagnosis, when delivered by a Psychology Practitioner (Trainee Clinical Psychologist)
* compare delivery by a Psychology Practitioner with the data from the Nurse delivered PrEliMS trial to explore which is more effective
* explore experience of the PrEliMS-2 intervention and potential improvements.
The investigators will recruit between three and seven people from an MS clinic who have received an MS diagnosis in the last year and consent to taking part. Participants will meet with a Psychology Practitioner (over the phone or online) once a week for four weeks, alongside completing the workbook. The investigators will also ask participants to complete questionnaires to examine their levels of psychological distress. Interviews will then be conducted to get feedback for refining the workbook.
The overall study will last a year
Detailed Description:
None
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?: