Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS

Study Overview
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Brief Summary
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The study will investigate whether cognitive behavioral psychotherapy (CBT) combined with prefrontal transcranial direct current stimulation (tDCS) is more efficacious with regard to symptom reduction in depressed patients than CBT combined with sham-tDCS or CBT alone.

Detailed Description
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Brain stimulation techniques are widely seen as promising treatment alternatives for patients not responding to or tolerating psychotropic medication. In particular, transcranial direct current stimulation (tDCS) is of special interest due to its potential to be used by a large number of patients because of its comparably ease of usage and good tolerability. Thus, a large number of studies investigating clinical effects of tDCS have been performed with statistically significant effects but that are of moderate clinical relevance. Clinical studies have mainly focused on the prefrontal cortex (PFC) as the main stimulation target based on findings of numerous studies indicating the lateral PFC to be a key dysfunctional node within brain networks involved in the pathophysiology of depression. 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.

Official Title
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Augmentation of Cognitive-Behavioral Psychotherapy With Prefrontal Direct Current Stimulation in Major Depression (Psychotherapy Plus)

Conditions
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Major Depression

Intervention / Treatment
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* Behavioral: cognitive behavioral therapy
* Device: tDCS
* Device: sham-tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - unipolar major depressive disorder Exclusion Criteria: neurological diseases or relevant psychiatric diseases other than major depressive disorder 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive behavioral therapy + tDCS<br>Group cognitive behavioral therapy combined with tDCS | Behavioral: cognitive behavioral therapy<br>* 12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks<br>Device: tDCS<br>* 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<br>|
| Active Comparator: cognitive behavioral therapy + sham-tDCS<br>Group cognitive behavioral therapy combined with sham-tDCS | Behavioral: cognitive behavioral therapy<br>* 12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks<br>Device: sham-tDCS<br>* 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<br>|
| Placebo Comparator: cognitive behavioral therapy<br>Group cognitive behavioral therapy only | Behavioral: cognitive behavioral therapy<br>* 12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity as measured by Montgomery Asberg Depression Rating Scale (MADRS) | MADRS ratings by trained clinicans, comparison between MADRS at baseline to MADRS post intervention, group comparison: treatment group vs. the two control interventions. | 6, 18 and 30 weeks after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, cognitive behavioral therapy