Active tDCSNCT06369532
Combination of Neurostimulation and Psychotherapy to Stop Worrying
A study testing Active tDCS in people with Active tDCS and Sham tDCS, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Active tDCS, Sham tDCS
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Mar 2024to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generalized anxiety disorder (GAD)
- Depressive disorder
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Ghent
Ghent, East-Flanders, 9000
Chris Baeken, Prof.
Josefien Dedoncker, M.Sc.
About this study
Official title: 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.
Read the 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.
- Conditions
- Active tDCS, Sham tDCS
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
During the whole therapy period, active tDCS group will receive active tDCS after CBT. They also receive active home-based tDCS.
Sham tDCSDevice
The sham tDCS group will receive sham tDCS after CBT. They also receive sham home-based tDCS.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS group | Active comparator | Patients will receive active tDCS during the therapy. Receives: Device: Active tDCS |
| Sham tDCS group | Sham comparator | Patients will receive sham tDCS during the therapy. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the therapeutic effect of the combination therapy for repetitive negative thinking
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.
Measured: Baseline, up to 7 weeks' therapy and up to 3 months' therapy
the consolidation effect of tDCS on CBT
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.
Measured: up to 7 weeks' therapy and up to 3 months' therapy
Secondary outcomes (1)
Change of neuroimaging data
The alteration of brain activity when performing cognitive task measured by EEG and emotional regulation task measured by fNIRS.
Measured: Baseline and up to 3 months' therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start6 Mar 2024
- Primary completion26 Sep 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Active tDCSStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Baeken, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369532
- Sponsor's protocol ID
- ONZ-2023-0460
- Status last verified
- Mar 2026
- First submitted
- 22 Jan 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baeken C, Wu GR, Rogiers R, Remue J, Lemmens GM, Raedt R. Cognitive behavioral based group psychotherapy focusing on repetitive negative thinking: Decreased uncontrollability of rumination is related to brain perfusion increases in the left dorsolateral prefrontal cortex. J Psychiatr Res. 2021 Apr;136:281-287. doi: 10.1016/j.jpsychires.2021.02.011. Epub 2021 Feb 13.
PubMed 33621914Sathappan AV, Luber BM, Lisanby SH. The Dynamic Duo: Combining noninvasive brain stimulation with cognitive interventions. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:347-360. doi: 10.1016/j.pnpbp.2018.10.006. Epub 2018 Oct 9.
PubMed 30312634Dedoncker J, Baeken C, De Raedt R, Vanderhasselt MA. Combined transcranial direct current stimulation and psychological interventions: State of the art and promising perspectives for clinical psychology. Biol Psychol. 2021 Jan;158:107991. doi: 10.1016/j.biopsycho.2020.107991. Epub 2020 Nov 21.
PubMed 33232800
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Worrying, Learn to Let go Through a Combination of Neurostimulation and Psychotherapy
- ClinicalTrials.gov ID
- NCT06369532
- Acronym / sponsor ID
- ONZ-2023-0460
- Conditions
- Active tDCS, Sham tDCS
- Keywords
- transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS group | Active comparator | Device: Active tDCSPatients will receive active tDCS during the therapy. |
| Sham tDCS group | Sham comparator | Device: Sham tDCSPatients will receive sham tDCS during the therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generalized anxiety disorder (GAD)
- Depressive disorder
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSDuring the whole therapy period, active tDCS group will receive active tDCS after CBT. They also receive active home-based tDCS. | Device | Active tDCS group |
| Sham tDCSThe sham tDCS group will receive sham tDCS after CBT. They also receive sham home-based tDCS. | Device | Sham tDCS group |
Primary outcome
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.
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.
1 secondary outcome
Change of neuroimaging data
Time frame: Baseline and up to 3 months' therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 33621914Baeken C, Wu GR, Rogiers R, Remue J, Lemmens GM, Raedt R. Cognitive behavioral based group psychotherapy focusing on repetitive negative thinking: Decreased uncontrollability of rumination is related to brain perfusion increases in the left dorsolateral prefrontal cortex. J Psychiatr Res. 2021 Apr;136:281-287. doi: 10.1016/j.jpsychires.2021.02.011. Epub 2021 Feb 13.
- Results publication: PubMed 30312634Sathappan AV, Luber BM, Lisanby SH. The Dynamic Duo: Combining noninvasive brain stimulation with cognitive interventions. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:347-360. doi: 10.1016/j.pnpbp.2018.10.006. Epub 2018 Oct 9.
- Results publication: PubMed 33232800Dedoncker J, Baeken C, De Raedt R, Vanderhasselt MA. Combined transcranial direct current stimulation and psychological interventions: State of the art and promising perspectives for clinical psychology. Biol Psychol. 2021 Jan;158:107991. doi: 10.1016/j.biopsycho.2020.107991. Epub 2020 Nov 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Baeken principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Active tDCS and Sham tDCS, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Baeken (+32476209841, Chris.Baeken@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369532, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.