Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369532
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-01-22
Brief Title:
Combination of Neurostimulation and Psychotherapy to Stop Worrying
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Stop Worrying Learn to Let go Through a Combination of Neurostimulation and Psychotherapy
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study aims to investigate whether the combination of transcranial Direct Current Stimulation tDCS and cognitive-behavioral therapy CBT is more effective for treating repetitive negative thinking RNT in patients with the symptom of high rumination High ruminators will be included Group1 active tDCS-CBT group Group2 sham tDCS-CBT group All patients will receive active or sham tDCS
Detailed Description:
A psychoeducational CBT-based group intervention called Drop It specifically for the treatment of repetitive negative thinking RNT which has been proved to be effective in reducing RNT tDCS is one of the emerging non-invasive brain stimulations techniques that can also be used to alter RNT Our aim is to explore the therapeutic effect of this combination
The study consists of 2 stages In the first stage the participants will come to the university hospital for 7 weeks CBT sessions the Drop It intervention with one session per week After each CBT session both groups will receive sham or active tDCS Stimulation will be applied for 30 min after the CBT session
In the second stage after the 7th weekly CBT session participants will take the devices home to apply daily home-based tDCS stimulations for 4 weeks After 4 weeks participants will return to the university hospital for the final CBT session
Neuroimaging Electroencephalogram EEG and functional Near-Infrared Spectroscopy fNIRS scan will be used to measure electrical activity and cortical hemodynamic activity in the brain Both of these methods are non-invasive neuroimaging techniques which are done by placing electrodes on the scalp to pick up the signals produced by the brain
EEG and fNIRS scans will be performed at baseline and after 3 months therapy
To examine the effect of the worry course combined with tDCS on thinking and acting the investigators will ask the participants to complete various questionnaires that assess the nature and extent of worry the presence of depressive complaints the presence of anxiety problems and the extent of quality of life as experienced by the participants Participants will also be evaluated by a psychiatrist from the service This evaluation will take place at baseline just after the end of the Drop It course and after a 3-month follow-up Two questionnaires will also be used after each session to measure the state rumination following the combination therapy of CBT and tDCS
The study consists of 2 stages In the first stage the participants will come to the university hospital for 7 weeks CBT sessions the Drop It intervention with one session per week After each CBT session both groups will receive sham or active tDCS Stimulation will be applied for 30 min after the CBT session
In the second stage after the 7th weekly CBT session participants will take the devices home to apply daily home-based tDCS stimulations for 4 weeks After 4 weeks participants will return to the university hospital for the final CBT session
Neuroimaging Electroencephalogram EEG and functional Near-Infrared Spectroscopy fNIRS scan will be used to measure electrical activity and cortical hemodynamic activity in the brain Both of these methods are non-invasive neuroimaging techniques which are done by placing electrodes on the scalp to pick up the signals produced by the brain
EEG and fNIRS scans will be performed at baseline and after 3 months therapy
To examine the effect of the worry course combined with tDCS on thinking and acting the investigators will ask the participants to complete various questionnaires that assess the nature and extent of worry the presence of depressive complaints the presence of anxiety problems and the extent of quality of life as experienced by the participants Participants will also be evaluated by a psychiatrist from the service This evaluation will take place at baseline just after the end of the Drop It course and after a 3-month follow-up Two questionnaires will also be used after each session to measure the state rumination following the combination therapy of CBT and tDCS
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