NCT02633449

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

December 15, 2015

Last Update Submit

August 24, 2021

Conditions

Major Depression

Keywords

tDCScognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

cognitive behavioral therapy + tDCS

EXPERIMENTAL

Group cognitive behavioral therapy combined with tDCS

Behavioral: cognitive behavioral therapyDevice: tDCS

cognitive behavioral therapy + sham-tDCS

ACTIVE COMPARATOR

Group cognitive behavioral therapy combined with sham-tDCS

Behavioral: cognitive behavioral therapyDevice: sham-tDCS

cognitive behavioral therapy

PLACEBO COMPARATOR

Group cognitive behavioral therapy only

Behavioral: cognitive behavioral therapy

Interventions

cognitive behavioral therapyBEHAVIORAL

12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks

cognitive behavioral therapycognitive behavioral therapy + sham-tDCScognitive behavioral therapy + tDCS
tDCSDEVICE

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 + tDCS
sham-tDCSDEVICE

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 + sham-tDCS

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- unipolar major depressive disorder

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Medicine Berlin, Department of Psychiatry and Psychotherapy

Berlin, 12203, Germany

Location

Related Publications (2)

  • 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.

    PMID: 35442431DERIVED

  • 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.

    PMID: 29214483DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Cognitive Behavioral TherapyTranscranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesElectric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesElectroshockPsychological Techniques

Study Officials

  • Malek Bajbouj, Prof. Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 17, 2015

Study Start

February 1, 2016

Primary Completion

November 15, 2019

Study Completion

January 30, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

DE(1)