Combination of Neurostimulation and Psychotherapy to Stop Worrying

March 11, 2026 updated by: University Hospital, Ghent

Stop Worrying, Learn to Let go Through a Combination of Neurostimulation and Psychotherapy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • East-Flanders
      • Ghent, East-Flanders, Belgium, 9000
        • Recruiting
        • University Hospital Ghent
        • Contact:
          • Chris Baeken, Prof.
        • Contact:
          • Josefien Dedoncker, M.Sc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active tDCS group
Patients will receive active tDCS during the therapy.
Device: Active tDCS
During the whole therapy period, active tDCS group will receive active tDCS after CBT. They also receive active home-based tDCS.
Sham Comparator: Sham tDCS group
Patients will receive sham tDCS during the therapy.
Device: Sham tDCS
The sham tDCS group will receive sham tDCS after CBT. They also receive sham home-based tDCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the therapeutic effect of the combination therapy for repetitive negative thinking
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.
Baseline, up to 7 weeks' therapy and up to 3 months' therapy
the consolidation effect of tDCS on CBT
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.
up to 7 weeks' therapy and up to 3 months' therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of neuroimaging data
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.
Baseline and up to 3 months' therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Chris Baeken, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

December 20, 2027

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ONZ-2023-0460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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