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Search / Trial NCT06369532

Combination of Neurostimulation and Psychotherapy to Stop Worrying

Launched by UNIVERSITY HOSPITAL, GHENT · Apr 12, 2024

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Transcranial Direct Current Stimulation

ClinConnect Summary

This clinical trial is exploring whether combining a treatment called transcranial Direct Current Stimulation (tDCS) with cognitive-behavioral therapy (CBT) can help people who often worry or think negatively. The study focuses on patients with generalized anxiety disorder (GAD) and depression who experience high levels of repetitive negative thinking. Participants will be divided into two groups: one will receive the active tDCS treatment along with CBT, while the other will receive a placebo version of tDCS that doesn’t have any real effect, also along with CBT.

To be eligible for this trial, participants should be between the ages of 18 and 65 and must have a diagnosis of GAD or depression. However, those with other serious mental health issues, substance abuse problems, or who cannot commit to attending all therapy sessions will not qualify. If you participate, you can expect to attend eight therapy sessions and receive four weeks of tDCS treatment. This study is currently recruiting, and it aims to find out if this combined approach is more effective in reducing worry and negative thoughts compared to CBT alone.

Gender

ALL

Eligibility 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).

About University Hospital, Ghent

University Hospital Ghent is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. Located in Ghent, Belgium, the hospital is affiliated with Ghent University, fostering a collaborative environment that integrates cutting-edge medical research with high-quality patient care. With a diverse range of specialized departments and a dedicated team of researchers and clinicians, University Hospital Ghent is at the forefront of developing new therapies and improving treatment protocols, aiming to enhance patient outcomes and contribute to the global medical community.

Locations

Ghent, East Flanders, Belgium

Patients applied

0 patients applied

Trial Officials

Chris Baeken

Principal Investigator

University Ghent

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported