Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05953519
Status:
RECRUITING
Last Update Posted:
2023-07-20
First Post:
2023-04-12
Brief Title:
Meeting an Unmet Need in Multiple Sclerosis
Sponsor:
Kessler Foundation
Organization:
Kessler Foundation
Study Overview
Official Title:
Meeting an Unmet Need in Multiple Sclerosis MS An Evaluation of the Effectiveness of a Transdiagnostic Psychological Treatment and Its Outcomes
Status:
RECRUITING
Status Verified Date:
2023-07
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:
The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes eg improved well-being QOL coping etc that may occur in tandem
Detailed Description:
The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes eg improved well-being QOL coping etc that may occur in tandem
To achieve this the investigation has the following specific aims
Specific Aim 1 Conduct a pilot Randomized Controlled Trial RCT of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in reducing depression and anxiety
Hypothesis 1 Individuals who participate in the Unified Protocol intervention will report a decrease in their depression and anxiety compared to individuals in the control group
Specific Aim 2 Conduct a pilot RCT of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in improving secondary outcomes of psychological well-being QOL coping and MS symptomatology over time
Hypothesis 2 Individuals who participate in the Unified Protocol intervention will report an increase in psychological well-being QOL coping and MS symptomatology over time compared to participants in the control group
To achieve this the investigation has the following specific aims
Specific Aim 1 Conduct a pilot Randomized Controlled Trial RCT of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in reducing depression and anxiety
Hypothesis 1 Individuals who participate in the Unified Protocol intervention will report a decrease in their depression and anxiety compared to individuals in the control group
Specific Aim 2 Conduct a pilot RCT of the Unified Protocol among individuals with MS to determine the effectiveness of the intervention in improving secondary outcomes of psychological well-being QOL coping and MS symptomatology over time
Hypothesis 2 Individuals who participate in the Unified Protocol intervention will report an increase in psychological well-being QOL coping and MS symptomatology over time compared to participants in the control group
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