Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS

• ClinicalTrials.gov Identifier: NCT02633449
• Recruitment Status: Active, not recruiting
• First Posted: December 17, 2015
• Last Update Posted: December 20, 2019
• Sponsor: Charite University, Berlin, Germany
• Collaborators: University of München; University Hospital Tuebingen; University of Freiburg; University of Leipzig; Central Institute of Mental Health, Mannheim
• Information provided by (Responsible Party): Malek Bajbouj, Charite University, Berlin, Germany

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Major Depression	Behavioral: cognitive behavioral therapy; Device: tDCS; Device: sham-tDCS	Not Applicable

Detailed Description:

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 Design

• 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
• Actual Primary Completion Date: November 15, 2019
• Estimated Study Completion Date: January 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: cognitive behavioral therapy + tDCS; Group cognitive behavioral therapy combined with tDCS	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
Active Comparator: cognitive behavioral therapy + sham-tDCS; Group cognitive behavioral therapy combined with sham-tDCS	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
Placebo Comparator: cognitive behavioral therapy; Group cognitive behavioral therapy only	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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Germany

Charité University Medicine Berlin, Department of Psychiatry and Psychotherapy

Berlin, Germany, 12203

Sponsors and Collaborators

Charite University, Berlin, Germany

University of München

University Hospital Tuebingen

University of Freiburg

University of Leipzig

Central Institute of Mental Health, Mannheim

Investigators

• Principal Investigator: Malek Bajbouj, Prof. Dr.; Charite University, Berlin, Germany

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Malek Bajbouj, Prof. Dr., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT02633449
• Other Study ID Numbers: 01EE1403F
• First Posted: December 17, 2015
• Last Update Posted: December 20, 2019
• Last Verified: December 2019

Keywords provided by Malek Bajbouj, Charite University, Berlin, Germany:

tDCS; cognitive behavioral therapy

Additional relevant MeSH terms:

Depression; Depressive Disorder, Major; Behavioral Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders