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Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06369532

Combining Brain Stimulation and Cognitive-Behavioral Therapy to Reduce Worrying in Adults with Anxiety or Depression

Led by University Hospital, Ghent · Updated on 2026-03-12

85

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether combining transcranial Direct Current Stimulation tDCS with cognitive-behavioral therapy CBT improves treatment for repetitive negative thinking RNT in patients who experience high levels of rumination. This study includes patients with generalized anxiety disorder or depressive disorder and compares active tDCS combined with CBT to sham inactive tDCS combined with CBT to evaluate their therapeutic effects. The study has two stages. In the first stage, participants attend weekly CBT group sessions called Drop It for 7 weeks, each followed by either active or sham tDCS applied for 30 minutes. In the second stage, after these sessions, participants use the tDCS devices at home daily for 4 weeks, continuing with either active or sham stimulation, then return for a final CBT session. Neuroimaging scans EEG and fNIRS are done at the start and after 3 months of therapy to measure brain activity. During the study, participants complete questionnaires assessing worry, depression, anxiety, and quality of life at baseline, after the therapy course, and at 3-month follow-up. Psychiatrists also evaluate participants at these points. Questionnaires measuring rumination are completed after each session. The main outcomes are the therapeutic effect of the combination therapy and the lasting impact of tDCS on CBT benefits, with safety and brain activity monitored over up to 3 months. Participation lasts approximately 3 months.

CONDITIONS

Brief Title

Combination of Neurostimulation and Psychotherapy to Stop Worrying

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • Diagnosis of generalized anxiety disorder (GAD)
  • Diagnosis of depressive disorder
  • Ability to commit to 8 sessions of cognitive-behavioral therapy (CBT)
  • Ability to receive 4 weeks of transcranial Direct Current Stimulation (tDCS)
  • Sufficient knowledge of Dutch language
Not Eligible

You will not qualify if you...

  • Presence of psychiatric disorders other than GAD or depression as assessed by a senior psychiatrist
  • Abuse of alcohol, drugs, or medications not prescribed by a doctor
  • Lack of consent to participate in measurements such as questionnaires, fNIRS, or EEG
  • Acute or chronic suicidality
  • Acute psychosis or manic depressive disorder
  • Inability to commit to the full therapy and stimulation schedule

Research Team

C

Chris Baeken

S

Sara De Witte

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