Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408662
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-06
Brief Title:
Remote Delivery of a Mindfulness-based Intervention for Tics
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Remote Delivery of a Mindfulness-based Intervention for Tics
Status:
RECRUITING
Status Verified Date:
2024-05
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:
MBIT
Brief Summary:
This research study is being done to compare a mindfulness-based intervention for tics MBIT to psychoeducation with relaxation and supportive therapy PRST for individuals with Tourettes syndrome or Persistent Tic Disorders collectively TS It is the investigators hope that this information cam be used to improve current treatments for individuals with TS
Detailed Description:
Tourettes syndrome and other persistent tic disorders collectively TS is a condition that onsets in childhood and affects 1 of the population Alongside motor and vocal tics patients with TS experience distressing somatosensory sensations ie premonitory urges and co-occurring mental health conditions such as anxiety disorders depressive disorders obsessive-compulsive disorder OCD and ADHD Tics and comorbid symptoms cause individuals with TS significant distress and impairment across life domains eg physical social academic occupational emotional and familial Two evidence-based treatments exist for TS behavior therapy and pharmacotherapy Behavior therapy often referred to as habit reversal training HRT or the comprehensive behavioral intervention for tics CBIT is an evidence-based treatment that has been shown to reduce the severity of tic symptoms and has a low risk for adverse effects Although behavior therapy is recognized as a first-line intervention for TS less than 40 of adults with TS respond to this evidence-based treatment Additionally current behavioral interventions are often inaccessible for adults with TS While pharmacotherapy for tic management eg antipsychotic medications has been shown to be effective these treatments can have adverse side effects with detrimental health consequences Thus there is a critical need for new treatments for adults with TS that are efficacious for reducing tic severity beneficial for co-occurring conditions and have few adverse health effects Mindfulness-based interventions have proven beneficial for adults with a wide range of neuropsychiatric conditions Based on the investigators prior work the investigators believe that a mindfulness-based intervention for tics MBIT is beneficial for adults with TS
This project is a randomized controlled trial RCT that will compare the efficacy of a mindfulness-based intervention for tics MBIT to psychoeducation with relaxation and supportive therapy PRST in 150 adults with TS All interventions and assessments will be delivered remotely using secure telehealth services platforms and online electronic data capture systems An independent evaluator IE masked to treatment condition will administer all assessments during the treatment and follow-up periods The investigators will test the mechanisms by which MBIT reduces tic severity and examine the efficacy of MBIT relative to PRST for common co-occurring psychiatric symptoms and quality of life impairments-towards treating the whole person Finally the investigators will explore the sustained therapeutic improvement from MBIT over a 6-month follow-up period focusing on tic severity tic-related impairment co-occurring psychiatric symptoms and quality of life
This project is a randomized controlled trial RCT that will compare the efficacy of a mindfulness-based intervention for tics MBIT to psychoeducation with relaxation and supportive therapy PRST in 150 adults with TS All interventions and assessments will be delivered remotely using secure telehealth services platforms and online electronic data capture systems An independent evaluator IE masked to treatment condition will administer all assessments during the treatment and follow-up periods The investigators will test the mechanisms by which MBIT reduces tic severity and examine the efficacy of MBIT relative to PRST for common co-occurring psychiatric symptoms and quality of life impairments-towards treating the whole person Finally the investigators will explore the sustained therapeutic improvement from MBIT over a 6-month follow-up period focusing on tic severity tic-related impairment co-occurring psychiatric symptoms and quality of life
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AT012455 | NIH | None | httpsreporternihgovquickSearchR01AT012455 |