Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7 participants
OBSERVATIONAL
2018-07-20
2019-05-01
Brief Summary
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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.
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Detailed Description
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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 person's 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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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All participants
Semi-structured interview and drop attack diary
Semi-structured interview
One-hour interview with researcher
Drop attack diary
Diary of any drop attacks experienced within an 8 week period
Interventions
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Semi-structured interview
One-hour interview with researcher
Drop attack diary
Diary of any drop attacks experienced within an 8 week period
Eligibility Criteria
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Inclusion Criteria
2. Idiopathic drop attacks occurring 6+ times per year
3. Having previously completed extensive investigation into possible cause of drop attacks
4. Able to provide informed consent
Exclusion Criteria
2. Drop attacks due to malfunction of the lower limbs, changes in body or head posture, or vertigo.
18 Years
ALL
No
Sponsors
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NHS Lothian
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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Emily Revell
Trainee Clinical Psychologist
Locations
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Western General Hospital (NHS Lothian)
Edinburgh, Scotland, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CAHSS1710/03
Identifier Type: -
Identifier Source: org_study_id
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