Combining brain stimulation and therapy to reduce worrying
Stop Worrying, Learn to Let go Through a Combination of Neurostimulation and Psychotherapy
This study is testing if combining brain stimulation with therapy can help people who often worry less than just therapy alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, East-Flanders) |
| Trial ID | NCT06369532 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of combining transcranial Direct Current Stimulation (tDCS) with cognitive-behavioral therapy (CBT) to treat repetitive negative thinking in patients with high rumination. Participants will undergo a 7-week CBT intervention followed by home-based tDCS for 4 weeks. The study will utilize non-invasive neuroimaging techniques, including EEG and fNIRS, to assess brain activity before and after the therapy. The goal is to determine if this combined approach is more effective than CBT alone.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with generalized anxiety disorder or depressive disorder who experience high levels of rumination.
Not a fit: Patients with other psychiatric conditions, acute suicidality, or those unable to commit to the therapy sessions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce symptoms of anxiety and depression related to repetitive negative thinking.
How similar studies have performed: While the combination of tDCS and CBT is a novel approach, previous studies have shown promise in using tDCS for various psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Ghent, East-Flanders
- University Hospital Ghent — Ghent, East-Flanders, Belgium (Recruiting)
Study contacts
- Principal investigator: Chris Baeken — University Ghent
- Study coordinator: Chris Baeken
- Email: Chris.Baeken@ugent.be
- Phone: +32476209841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.