Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS
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| ClinicalTrials.gov Identifier: NCT02633449 |
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Recruitment Status :
Recruiting
First Posted : December 17, 2015
Last Update Posted : July 13, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depression | Behavioral: cognitive behavioral therapy Device: tDCS Device: sham-tDCS | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 192 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Augmentation of Cognitive-Behavioral Psychotherapy With Prefrontal Direct Current Stimulation in Major Depression (Psychotherapy Plus) |
| Study Start Date : | February 2016 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | April 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: cognitive behavioral therapy + tDCS
Group cognitive behavioral therapy combined with tDCS
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Behavioral: 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 Device: 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 |
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Active Comparator: cognitive behavioral therapy + sham-tDCS
Group cognitive behavioral therapy combined with sham-tDCS
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Behavioral: 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 Device: 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 |
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Placebo Comparator: cognitive behavioral therapy
Group cognitive behavioral therapy only
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Behavioral: 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 |
- Change in depression severity as measured by Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 6, 18 and 30 weeks after randomization ]MADRS ratings by trained clinicans, comparison between MADRS at baseline to MADRS post intervention, group comparison: treatment group vs. the two control interventions.
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| Ages Eligible for Study: | 20 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633449
| Contact: Malek Bajbouj, Prof. Dr. | +4930450517542 | malek.bajbouj@charite.de | |
| Contact: Sabine Aust, Dr. | +4930450517779 | aust.sabine@charite.de |
| Germany | |
| Charité University Medicine Berlin, Department of Psychiatry and Psychotherapy | Recruiting |
| Berlin, Germany, 12203 | |
| Contact: Sabine Aust, Dr. +4930450517779 psychotherapie-plus@charite.de | |
| Principal Investigator: | Malek Bajbouj, Prof. Dr. | Charite University, Berlin, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Malek Bajbouj, Prof. Dr., Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT02633449 History of Changes |
| Other Study ID Numbers: |
01EE1403F |
| First Posted: | December 17, 2015 Key Record Dates |
| Last Update Posted: | July 13, 2018 |
| Last Verified: | July 2018 |
Keywords provided by Malek Bajbouj, Charite University, Berlin, Germany:
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tDCS cognitive behavioral therapy |
Additional relevant MeSH terms:
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Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |