Major DepressionNCT02633449
Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS
A study testing cognitive behavioral therapy and tDCS in people with Major Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- cognitive behavioral therapy and tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unipolar major depressive disorder
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité University Medicine Berlin, Department of Psychiatry and Psychotherapy
Berlin, 12203
About this study
Official title: Augmentation of Cognitive-Behavioral Psychotherapy With Prefrontal Direct Current Stimulation in Major Depression (Psychotherapy Plus)
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.
Read the 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.
- Conditions
- Major Depression
- Being tested
- cognitive behavioral therapy, tDCS, sham-tDCS
- Keywords
- tDCS, cognitive behavioral therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks
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
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
| Study group | Role | What they receive |
|---|---|---|
| cognitive behavioral therapy + tDCS | Experimental | Group cognitive behavioral therapy combined with tDCS Receives: Behavioral: cognitive behavioral therapy; Device: tDCS |
| cognitive behavioral therapy + sham-tDCS | Active comparator | Group cognitive behavioral therapy combined with sham-tDCS Receives: Behavioral: cognitive behavioral therapy; Device: sham-tDCS |
| cognitive behavioral therapy | Placebo comparator | Group cognitive behavioral therapy only Receives: Behavioral: cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6, 18 and 30 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completion15 Nov 2019
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of München, University Hospital Tuebingen, University of Freiburg, University of Leipzig, Central Institute of Mental Health, Mannheim
- Responsible party
- Principal investigator, Malek Bajbouj, Charite University, Berlin, Germany
- Investigators
- Malek Bajbouj, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633449
- Sponsor's protocol ID
- 01EE1403F
- Status last verified
- Aug 2021
- First submitted
- 15 Dec 2015
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35442431Bajbouj 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.
PubMed 29214483
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Cognitive-Behavioral Psychotherapy With Prefrontal Direct Current Stimulation in Major Depression (Psychotherapy Plus)
- ClinicalTrials.gov ID
- NCT02633449
- Acronym / sponsor ID
- 01EE1403F
- Conditions
- Major Depression
- Keywords
- tDCS, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of München, University Hospital Tuebingen, University of Freiburg, University of Leipzig, Central Institute of Mental Health, Mannheim
- Study start
- Feb 2016
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral therapy + tDCS | Experimental | Behavioral: cognitive behavioral therapy, Device: tDCSGroup cognitive behavioral therapy combined with tDCS |
| cognitive behavioral therapy + sham-tDCS | Active comparator | Behavioral: cognitive behavioral therapy, Device: sham-tDCSGroup cognitive behavioral therapy combined with sham-tDCS |
| cognitive behavioral therapy | Placebo comparator | Behavioral: cognitive behavioral therapyGroup cognitive behavioral therapy only |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- unipolar major depressive disorder
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapy12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks | Behavioural | cognitive behavioral therapy, cognitive behavioral therapy + sham-tDCS, cognitive behavioral therapy + tDCS |
| tDCStranscranial 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 | Device | cognitive behavioral therapy + tDCS |
| sham-tDCSsham 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 | Device | cognitive behavioral therapy + sham-tDCS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 35442431Aust 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.
- Derived from this study: PubMed 29214483Bajbouj 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malek Bajbouj, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy and tDCS in people with Major Depression, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression severity as measured by Montgomery Asberg Depression Rating Scale (MADRS) (time frame: 6, 18 and 30 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633449, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.