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Combination of Neurostimulation and Psychotherapy to Stop Worrying

ConditionsActive tDCSSham tDCS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Generalized anxiety disorder (GAD)

Depressive disorder

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active tDCS

    Device

    During the whole therapy period, active tDCS group will receive active tDCS after CBT. They also receive active home-based tDCS.

  • Sham tDCS

    Device

    The sham tDCS group will receive sham tDCS after CBT. They also receive sham home-based tDCS.

Treatment groups

85 Participants
are divided into 2 treatment groups
Group A: Active tDCS groupActive comparator 1 intervention
Group B: Sham tDCS groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, up to 7 weeks' therapy and up to 3 months' therapy
2

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.

Time frame
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.

Time frame
Baseline and up to 3 months' therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

Source ClinicalTrials.gov
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