University Hospital Ghent
Ghent, East-Flanders, 9000, Belgium
Location status: Recruiting
Location contact
Chris Baeken, Prof.
CONTACT
Josefien Dedoncker, M.Sc.
CONTACT
NCT Number: NCT06369532
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Ghent, East-Flanders, 9000, Belgium
Location status: Recruiting
Chris Baeken, Prof.
CONTACT
Josefien Dedoncker, M.Sc.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During the whole therapy period, active tDCS group will receive active tDCS after CBT. They also receive active home-based tDCS.
The sham tDCS group will receive sham tDCS after CBT. They also receive sham home-based tDCS.
Time frame: Baseline, up to 7 weeks' therapy and up to 3 months' therapy
Questionnaires including the Penn State Worry Questionnaire (PSWQ, range 16-80), the Leuven adaptation of the rumination on sadness Scale (LARSS, range 21-105) , and the Ruminative Response Scale (RRS, range 22-88) will be used to measure the alteration of repetitive negative thinking. Higher scores suggest a higher level of worry or rumination. The Beck Depression Inventory (BDI), the Hamilton Depression Rating Scale (HDRS) and other related questionnaires will also be included.
Time frame: up to 7 weeks' therapy and up to 3 months' therapy
The Self-Critical Rumination scale (SCRS, range 0-40) and the Perseverative Thinking Questionnaire (PTQ, range 0-60) will be measures after each session (8 sessions in total). Higher scores suggest a higher level of self-critical ruminative thoughts or repetitive negative thinking.
Time frame: Baseline and up to 3 months' therapy
The alteration of brain activity when performing cognitive task measured by EEG and emotional regulation task measured by fNIRS.
Contact information is provided by the study sponsor or research team.
Chris Baeken
CONTACT
Sara De Witte
CONTACT
University Hospital, Ghent
Other
Stop Worrying, Learn to Let go Through a Combination of Neurostimulation and Psychotherapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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