Combination of Neurostimulation and Psychotherapy to Stop Worrying

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2027-02-20

Brief Summary

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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.

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Detailed Description

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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

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Active tDCS Sham tDCS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Participants will be allocated into two groups randomly (using a code). The psychotherapist, the study managers and the patients will not be aware of treatment allocation.

Study Groups

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Active tDCS group

Patients will receive active tDCS during the therapy.

Group Type ACTIVE_COMPARATOR

Active tDCS

Intervention Type DEVICE

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

Sham tDCS group

Patients will receive sham tDCS during the therapy.

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

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

Interventions

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Active tDCS

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

Intervention Type DEVICE

Sham tDCS

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

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No