Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS
NCT ID: NCT02633449
Last Updated: 2021-08-25
Study Results
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Basic Information
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COMPLETED
NA
209 participants
INTERVENTIONAL
2016-02-29
2021-01-30
Brief Summary
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Detailed Description
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Studies in clinical and healthy participants indicate that tDCS is capable of positively augmenting prefrontal functions that are relevant for a successful cognitive behavioral therapy. More specifically, it has been shown that tDCS is capable of improving reappraisal strategies as well as the use of cognitive control techniques .
To date, previous studies have mainly addressed global antidepressant effects of tDCS and not effects on more circumscribed phenotypes mediated by top-down PFC processes such as impaired or biased emotional learning processes. All these trials have applied the stimulation to patients while being in a resting position. Nonetheless, recent neuropsychological studies indicate that tDCS effects appear to be "activity dependent", meaning that the stimulation effects are greater when the brain region being stimulated is simultaneously engaged in a cognitive task. Therefore, in the present study we will apply tDCS to patients with unipolar major depressive disorder during cognitive behavioral therapy (CBT), a well-established and highly effective psychotherapeutic treatment for depression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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cognitive behavioral therapy + tDCS
Group cognitive behavioral therapy combined with tDCS
cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks
tDCS
transcranial direct current stimulation during cognitive behavioral therapy with delayed onset after 10 minutes for 30 minutes, 1-2 mA, anode over electrode position F3, cathode over F4
cognitive behavioral therapy + sham-tDCS
Group cognitive behavioral therapy combined with sham-tDCS
cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks
sham-tDCS
sham transcranial direct current stimulation during cognitive behavioral therapy with delayed onset after 10 minutes for 30 minutes, anode over electrode position F3, cathode over F4
cognitive behavioral therapy
Group cognitive behavioral therapy only
cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks
Interventions
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cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks
tDCS
transcranial direct current stimulation during cognitive behavioral therapy with delayed onset after 10 minutes for 30 minutes, 1-2 mA, anode over electrode position F3, cathode over F4
sham-tDCS
sham transcranial direct current stimulation during cognitive behavioral therapy with delayed onset after 10 minutes for 30 minutes, anode over electrode position F3, cathode over F4
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* current medication other than SSRI or Mirtazapine
* manic episodes (lifetime)
* psychotic symptoms (lifetime)
* treatment with psychotherapy within the past 2 years
* treatment with electroconvulsive therapy (lifetime)
20 Years
65 Years
ALL
No
Sponsors
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University of München
OTHER
University Hospital Tuebingen
OTHER
University of Freiburg
OTHER
University of Leipzig
OTHER
Central Institute of Mental Health, Mannheim
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Malek Bajbouj
Prof. Dr.
Principal Investigators
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Malek Bajbouj, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Locations
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Charité University Medicine Berlin, Department of Psychiatry and Psychotherapy
Berlin, , Germany
Countries
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References
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Aust S, Brakemeier EL, Spies J, Herrera-Melendez AL, Kaiser T, Fallgatter A, Plewnia C, Mayer SV, Dechantsreiter E, Burkhardt G, Strauss M, Mauche N, Normann C, Frase L, Deuschle M, Bohringer A, Padberg F, Bajbouj M. Efficacy of Augmentation of Cognitive Behavioral Therapy With Transcranial Direct Current Stimulation for Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jun 1;79(6):528-537. doi: 10.1001/jamapsychiatry.2022.0696.
Bajbouj M, Aust S, Spies J, Herrera-Melendez AL, Mayer SV, Peters M, Plewnia C, Fallgatter AJ, Frase L, Normann C, Behler N, Wulf L, Brakemeier EL, Padberg F. PsychotherapyPlus: augmentation of cognitive behavioral therapy (CBT) with prefrontal transcranial direct current stimulation (tDCS) in major depressive disorder-study design and methodology of a multicenter double-blind randomized placebo-controlled trial. Eur Arch Psychiatry Clin Neurosci. 2018 Dec;268(8):797-808. doi: 10.1007/s00406-017-0859-x. Epub 2017 Dec 6.
Other Identifiers
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01EE1403F
Identifier Type: -
Identifier Source: org_study_id
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