Combination of Neurostimulation and Psychotherapy to Stop Worrying (NCT06369532) | Clinical Trial Compass
RecruitingNot Applicable
Combination of Neurostimulation and Psychotherapy to Stop Worrying
Belgium85 participantsStarted 2024-03-06
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Generalized anxiety disorder (GAD)
* Depressive disorder
Exclusion Criteria:
* other psychiatric pathology than GAD or depression screened by senior psychiatrist by means of the Mini-International Neuropsychiatric Interview (MINI) and psychiatric anamnesis
* Abuse of alcohol, drugs or medication other than prescribed by general practitioner or psychiatrist
* no consent to participate in measurement (questionnaire, fNIRS or EEG)
* Insufficient knowledge of the current language (Dutch)
* Acute or chronic suicidality
* Acute psychosis or manic depressive disorder
* Inability to commit to 8 sessions of Cognitive-Behavioral Therapy (CBT) or receive 4 weeks of transcranial Direct Current Stimulation (tDCS).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines brain stimulation called tDCS with a talk therapy called CBT to target repetitive negative thinking — is this kind of combined approach something that makes sense for my specific situation, or would starting with CBT alone be a more established first step?
2The trial has a 'sham tDCS' group where the stimulation device is inactive, so some participants won't receive real brain stimulation — can you help me understand what that means for my chances of getting the actual treatment, and how that should factor into my decision?
3Since this trial is listed under 'Phase NA,' it seems like it may be exploring a newer or less-categorized type of intervention — what does that mean for how much is already known about the safety of combining tDCS with CBT?
4One of the main things this study is measuring is whether tDCS helps 'consolidate' or lock in the benefits of CBT — does the current evidence suggest this is a promising direction, and are there any known risks with tDCS that I should weigh before considering participation?
5Given that this trial is actively recruiting, what would the time commitment and session schedule actually look like for me, and could participating interfere with any other treatments I might be receiving for my mental health?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the therapeutic effect of the combination therapy for repetitive negative thinking
Timeframe: Baseline, up to 7 weeks' therapy and up to 3 months' therapy
2
the consolidation effect of tDCS on CBT
Timeframe: up to 7 weeks' therapy and up to 3 months' therapy