Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06302309
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-04
Brief Title:
Tackling Anxiety-related Freezing of Gait in People With Parkinsons Disease
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Managing the Mental State to Tackle Anxiety-related Freezing of Gait in People With Parkinsons Disease a Randomized Controlled Intervention Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
TACKLING-FOG
Brief Summary:
The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinsons Disease
Detailed Description:
Rationale
Freezing of Gait FOG is a common and disabling symptom in people with Parkinsons Disease PD characterized by paroxysmal episodes where there is an inability to step effectively despite attempting to do so Treatment consists of complementary pharmacological and non-pharmacological treatment options which unfortunately only partially alleviate FOG Anxiety has been found to contribute to the occurrence and exacerbation of FOG which often manifests itself in situations where people with FOG anticipate not being in control of their movements People with FOG are often aware of the feelings and situations that elicit FOG episodes but they rarely actively employ strategies targeting their mental state to improve FOG With the exception of general interventions including mindfulness yoga and meditation tailored strategies to ameliorate anxiety-related FOG have never been evaluated in a systematic manner
Objective
In this project we aim to evaluate whether a non-pharmacological and tailored intervention targeting anxiety- and stress-related FOG in people with PD is effective to reduce the impact of anxiety and stress on FOG Specifically we aim to study 1 the effect of four sessions of a managing the mental state intervention in people with disabling and anxiety-related FOG and 2 the key determinants of the effectiveness of the intervention to reduce the impact of anxiety and stress on FOG
Study design
This study is a randomized controlled trial RCT The intervention group will receive the intervention immediately after randomization while a waitlist control group receives the same intervention thereafter
Study population
Forty people with PD that experience daily FOG as objectified with the new-freezing of gait questionnaire will be included that is related to anxiety positive answer to the question Does FOG occur or get worse when you are anxious or stressed
Intervention
The intervention consists of four sessions of a managing the mental state intervention of which the first and second session will take place in the home-setting of the patient the two remaining sessions will take place remotely The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG identifying how people are allocating attention and engage in specific thought-processes eg worrisome thoughts during walking and educating patients about managing the mental state compensation strategies that involve ways to reduce anxiety or stress and will be specifically tailored to the individual patient
Main study parametersendpoints
The primary outcome involves the percentage of time frozen during a home-based gait trajectory with self-selected FOG hotspots Secondary outcomes involve the subjective impact of anxiety and stress on FOG as measured with a Visual Analogue Scale and the perceived levels of anxiety
Freezing of Gait FOG is a common and disabling symptom in people with Parkinsons Disease PD characterized by paroxysmal episodes where there is an inability to step effectively despite attempting to do so Treatment consists of complementary pharmacological and non-pharmacological treatment options which unfortunately only partially alleviate FOG Anxiety has been found to contribute to the occurrence and exacerbation of FOG which often manifests itself in situations where people with FOG anticipate not being in control of their movements People with FOG are often aware of the feelings and situations that elicit FOG episodes but they rarely actively employ strategies targeting their mental state to improve FOG With the exception of general interventions including mindfulness yoga and meditation tailored strategies to ameliorate anxiety-related FOG have never been evaluated in a systematic manner
Objective
In this project we aim to evaluate whether a non-pharmacological and tailored intervention targeting anxiety- and stress-related FOG in people with PD is effective to reduce the impact of anxiety and stress on FOG Specifically we aim to study 1 the effect of four sessions of a managing the mental state intervention in people with disabling and anxiety-related FOG and 2 the key determinants of the effectiveness of the intervention to reduce the impact of anxiety and stress on FOG
Study design
This study is a randomized controlled trial RCT The intervention group will receive the intervention immediately after randomization while a waitlist control group receives the same intervention thereafter
Study population
Forty people with PD that experience daily FOG as objectified with the new-freezing of gait questionnaire will be included that is related to anxiety positive answer to the question Does FOG occur or get worse when you are anxious or stressed
Intervention
The intervention consists of four sessions of a managing the mental state intervention of which the first and second session will take place in the home-setting of the patient the two remaining sessions will take place remotely The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG identifying how people are allocating attention and engage in specific thought-processes eg worrisome thoughts during walking and educating patients about managing the mental state compensation strategies that involve ways to reduce anxiety or stress and will be specifically tailored to the individual patient
Main study parametersendpoints
The primary outcome involves the percentage of time frozen during a home-based gait trajectory with self-selected FOG hotspots Secondary outcomes involve the subjective impact of anxiety and stress on FOG as measured with a Visual Analogue Scale and the perceived levels of anxiety
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