Ignite Creation Date:
2024-05-06 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03694769
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2018-10-01
Brief Title:
Investigating Drop Attacks
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
Developing a Psychological Understanding of Idiopathic Drop Attacks
Status:
COMPLETED
Status Verified Date:
2020-03
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 aim of this project is to better understand the experiences of people who have idiopathic drop attacks These falls have no identified medical cause but can cause people injuries such as bruising facial injuries and in some cases broken bones It can also make them worry about having more falls and the pain and embarrassment this would cause and stop them from going out There has been very little research in this area and there are currently no treatments
In this study ten people who experience idiopathic drop attacks will be interviewed at an outpatient clinic to understand more about them and the falls They will be asked in particular about the period of time around when they started having the falls and whether there are aware of any triggers Participants will also be asked to write accounts of these drop attacks after they have happened for a period of eight weeks They will be asked to describe what they were thinking and feeling and how they felt in themselves before and after the fall
This information will allow the researcher to look at common experiences that people who experience these falls have This understanding could help to identify whether a psychological approach to treatment could help individuals to manage and cope with this condition
In this study ten people who experience idiopathic drop attacks will be interviewed at an outpatient clinic to understand more about them and the falls They will be asked in particular about the period of time around when they started having the falls and whether there are aware of any triggers Participants will also be asked to write accounts of these drop attacks after they have happened for a period of eight weeks They will be asked to describe what they were thinking and feeling and how they felt in themselves before and after the fall
This information will allow the researcher to look at common experiences that people who experience these falls have This understanding could help to identify whether a psychological approach to treatment could help individuals to manage and cope with this condition
Detailed Description:
Design
In this exploratory qualitative study neurology outpatients with ongoing Idiopathic Drop Attacks IDAs will undergo psychological assessment and complete written diaries for eight weeks Throughout the study participants will receive treatment as usual from a neurologist
Procedure
Participants will be recruited from a neurology outpatient clinic at the Department of Clinical Neurosciences in Edinburgh where they will be approached by their consultant who will give them a participant information sheet If they are interested in taking part a meeting will be set up with the researcher to discuss the study further and obtain written informed consent
Participants will then meet with the researcher to complete an initial psychological interview which will be audio recorded This interview will follow a standard initial psychological interview structure and will aim to gain information about the persons experiences of IDAs along with relevant personal and social history
Following this initial interview participants will be asked to record written accounts of any IDA detailing their thoughts physical arousal feelings and behaviour as close to the event as possible They will be encouraged to record detailed accounts outlining the period before during and after the episode in order to identify any potential triggers They will be shown an example of a completed diary in order to help them to understand what they need to do Participants will be asked to record such events over a period of eight weeks during which the researcher will contact them fortnightly to discuss any difficulties or concerns If participants do not experience any drop attacks during this period they will be asked if they want to continue recording diaries for an additional two to four weeks
Following completion of this period participants will meet again with the researcher to return the diaries and discuss any patterns noticed in the interview and diaries The researcher will also answer any further questions that the participant has about the study
In this exploratory qualitative study neurology outpatients with ongoing Idiopathic Drop Attacks IDAs will undergo psychological assessment and complete written diaries for eight weeks Throughout the study participants will receive treatment as usual from a neurologist
Procedure
Participants will be recruited from a neurology outpatient clinic at the Department of Clinical Neurosciences in Edinburgh where they will be approached by their consultant who will give them a participant information sheet If they are interested in taking part a meeting will be set up with the researcher to discuss the study further and obtain written informed consent
Participants will then meet with the researcher to complete an initial psychological interview which will be audio recorded This interview will follow a standard initial psychological interview structure and will aim to gain information about the persons experiences of IDAs along with relevant personal and social history
Following this initial interview participants will be asked to record written accounts of any IDA detailing their thoughts physical arousal feelings and behaviour as close to the event as possible They will be encouraged to record detailed accounts outlining the period before during and after the episode in order to identify any potential triggers They will be shown an example of a completed diary in order to help them to understand what they need to do Participants will be asked to record such events over a period of eight weeks during which the researcher will contact them fortnightly to discuss any difficulties or concerns If participants do not experience any drop attacks during this period they will be asked if they want to continue recording diaries for an additional two to four weeks
Following completion of this period participants will meet again with the researcher to return the diaries and discuss any patterns noticed in the interview and diaries The researcher will also answer any further questions that the participant has about the study
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