Major Depressive DisorderPSYCHOBOOSTNCT05866042
Boosting Psychotherapy Effects by Means of Transcranial Direct Current Stimulation
A study testing tDCS in people with Major Depressive Disorder, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The present study involves the administration of three types of interventions in patients with depressive episode in the context of DDM. Two-thirds of the patients will carry out a course of excitatory tDCS sessions on the left DLPFC, so as to improve attention regulation on information characterized by negative… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 30 Apr 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent to study
- Ability to understand and speak the Italian language
- DSM-5 diagnosis of Major Depressive Disorder.
- Ongoing depressive episode of at least moderate intensity (HAM-D> 18)
Who cannot join
- Previous tDCS sessions with significant side effects
- Positive personal history for seizures
- Positive family history for epileptic disease
- Positive personal history for neurological disease
- Positive personal history for head trauma with loss of consciousness
- Positive personal history for frequent and severe headaches
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- Positive personal history for neurosurgical procedures
- Prior implantation of neurostimulation implants (DBS, VNS, etc.)
- Prior implantation of defibrillator or pace-maker
- Possibility of pregnancy or established pregnancy
- Substance or alcohol abuse in the past 6 months
- Positive personal history for schizophrenia or schizoaffective disorder
- Positive personal history of intellectual disability ("mental retardation")
- Current hospitalization
- Cardiac, respiratory, renal, hepatic failure, immunosuppression status
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, MI, 20100
About this study
The present study involves the administration of three types of interventions in patients with depressive episode in the context of DDM. Two-thirds of the patients will carry out a course of excitatory tDCS sessions on the left DLPFC, so as to improve attention regulation on information characterized by negative emotions and have an antidepressant effect, simultaneously with the performance of a task, the attentional training technique (ATT), aimed at achieve effective management of emotions characterized by negative emotions and which constitutes a fundamental exercise of MCT. In half of the patients who will undergo tDCS treatment, after each session of stimulation, an MCT session will be carried out. In addition, before and after the cycle of tDCS sessions and MCT sessions will be explored, in a subgroup of patients, in the context of a pilot study, the TMS- EEG of the change in depressive symptomatology, which can be correlated with the different proposed therapeutic interventions.
Read the detailed description
The study - interventional, nonpharmacological, using medical devices, nonprofit - is aimed at evaluating the potential effectiveness of a multimodal intervention for the treatment of unipolar depression. The intervention involves the use of a neuro-stimulation technique, the Transcranial Direct Current Stimulation (transcranial Direct Current Stimulation - tDCS), combined with a psychotherapy intervention, metacognitive therapy (MetaCognitive Therapy, MCT). TDCS is a noninvasive neurostimulation technique involving the transcranial application of a low-amperage electric current at a region of the cerebral cortex involved in the pathogenesis of major depression, the dorsolateral prefrontal cortex. It has been demonstrated how such stimulation has a neuromodulating effect on synaptic plasticity, with efficacy in unipolar major depression. The technique also has a good safety, as it is not associated with major side effects. MCT is based on the metacognitive model, according to which psychopathological processes are consequent to a cognitive style characterized by repetitive forms of thinking (such as rumination) and maladaptive behaviors such as avoidance and thought suppression. The MCT, through attention training techniques, detached mindfulness and behavioral interventions on metacognitions, has shown effectiveness in major depressive disorder comparable to that of psychotherapeutic interventions considered, within psychotherapies, to be first-line such as cognitive-behavioral therapy. The experimental design will be that of a randomized, double-blind study with three arms of treatment, each consisting of 8 sessions, involving the administration of 1) the neurostimulation intervention (tDCS), 2) of the psychotherapeutic intervention alone (MCT), 3) of both techniques in consecution (tDCS-MCT). This design is aimed at evaluating a potential additive/synergistic effect of the two interventions when combined. During the tDCS sessions, each lasting 20 minutes, the patient will apply the technique of attention training, aimed at further activating the region stimulated by neurostimulation, so as to so as to amplify the plasticity stimulated by tDCS, achieving a synergistic effect. To follow, a 40-minute MCT session will be carried out. The effectiveness of these interventions will be assessed by heteroadministered and self-administered at time zero, after treatment, at two follow-ups of 6 and 12 months. Before and after the treatment cycle (tDCS sessions and MCT sessions), a subgroup of patients will be explored, in the context of a pilot study, the TMS-EEG correlates of the change in symptomatology depression, which can be correlated with the different proposed therapeutic interventions.
- Conditions
- Major Depressive Disorder
- Being tested
- tDCS
- 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.
tDCSDevice
TDCS is a noninvasive neurostimulation technique involving the transcranial application of a low-amperage electric current at a region of the cerebral cortex involved in the pathogenesis of major depression, the dorsolateral prefrontal cortex. In healthy subjects, the administration of excitatory tDCS on the left DLPFC improves the regulation of attention on information characterized by negative emotions, as does the administration of inhibitory tDCS on the DLPFC Right tDCS produces small changes in the neuronal membrane potential, thus increasing or decreasing the excitability of the stimulated tissue. Simultaneous administration to behavioral tasks designed to activate the stimulated cortical region should achieve a synergistic, amplifying the plasticity stimulated by the task.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Administration of active tDCS, not followed by MCT session, but by a usual visit psychiatric follow-up Receives: Device: tDCS |
| sham tDCS and MCT | No intervention | Administration of sham tDCS, followed by MCT session |
| active tDCS and MCT | Experimental | Administration of active tDCS, followed by MCT session Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the potential superiority, from the point of view of therapeutic efficacy in depression, of the approach of combined administration of tDCS and MCT, compared with interventions based tDCS alone or MCT alone.
Change in the Hamilton Depression Rating Scale will be used as parameters, during follow-up (end of treatment, 1, 3, 6 and 12 months).
Measured: end of treatment, 1, 3, 6 and 12 months
Secondary outcomes (1)
To evaluate the TMS-EEG correlates of change in depressive symptomatology, correlating them with the different proposed therapeutic interventions, in a subgroup of patients recruited, in the context of a pilot study.
Change, at the end of treatment, in TMS-EEG connectivity measures, in a subgroup of patients recruited 2. Change, during follow-up (end of treatment, 1, 3, 6 and 12 months), in the scores of the following scales:
- Beck Depression Inventory
- SCL-90
Remorse Rating Scales:
- Penn State Worry Questionnaire
- Metacognition Questionnaire-30
- Ruminative Response Scale
- Anger rumination scale Neuropsychological tests
- Digit span forward and backward
- Phonemic and semantic verbal fluency
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 May 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe 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, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866042
- Sponsor's protocol ID
- PSYCHOBOOST
- Acronym
- PSYCHOBOOST
- Status last verified
- May 2021
- First submitted
- 10 May 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Psychotherapy Effects by Means of Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT05866042
- Acronym / sponsor ID
- PSYCHOBOOST / PSYCHOBOOST
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 May 2023 (actual)
- 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 present study involves the administration of three types of interventions in patients with depressive episode in the context of DDM. Two-thirds of the patients will carry out a course of excitatory tDCS sessions on the left DLPFC, so as to improve attention regulation on information characterized by negative emotions and have an antidepressant effect, simultaneously with the performance of a task, the attentional training technique (ATT), aimed at achieve effective management of emotions characterized by negative emotions and which constitutes a fundamental exercise of MCT. In half of the patients who will undergo tDCS treatment, after each session of stimulation, an MCT session will be carried out. In addition, before and after the cycle of tDCS sessions and MCT sessions will be explored, in a subgroup of patients, in the context of a pilot study, the TMS- EEG of the change in depressive symptomatology, which can be correlated with the different proposed therapeutic interventions.
Detailed description
The study - interventional, nonpharmacological, using medical devices, nonprofit - is aimed at evaluating the potential effectiveness of a multimodal intervention for the treatment of unipolar depression. The intervention involves the use of a neuro-stimulation technique, the Transcranial Direct Current Stimulation (transcranial Direct Current Stimulation - tDCS), combined with a psychotherapy intervention, metacognitive therapy (MetaCognitive Therapy, MCT). TDCS is a noninvasive neurostimulation technique involving the transcranial application of a low-amperage electric current at a region of the cerebral cortex involved in the pathogenesis of major depression, the dorsolateral prefrontal cortex. It has been demonstrated how such stimulation has a neuromodulating effect on synaptic plasticity, with efficacy in unipolar major depression. The technique also has a good safety, as it is not associated with major side effects. MCT is based on the metacognitive model, according to which psychopathological processes are consequent to a cognitive style characterized by repetitive forms of thinking (such as rumination) and maladaptive behaviors such as avoidance and thought suppression. The MCT, through attention training techniques, detached mindfulness and behavioral interventions on metacognitions, has shown effectiveness in major depressive disorder comparable to that of psychotherapeutic interventions considered, within psychotherapies, to be first-line such as cognitive-behavioral therapy. The experimental design will be that of a randomized, double-blind study with three arms of treatment, each consisting of 8 sessions, involving the administration of 1) the neurostimulation intervention (tDCS), 2) of the psychotherapeutic intervention alone (MCT), 3) of both techniques in consecution (tDCS-MCT). This design is aimed at evaluating a potential additive/synergistic effect of the two interventions when combined. During the tDCS sessions, each lasting 20 minutes, the patient will apply the technique of attention training, aimed at further activating the region stimulated by neurostimulation, so as to so as to amplify the plasticity stimulated by tDCS, achieving a synergistic effect. To follow, a 40-minute MCT session will be carried out. The effectiveness of these interventions will be assessed by heteroadministered and self-administered at time zero, after treatment, at two follow-ups of 6 and 12 months. Before and after the treatment cycle (tDCS sessions and MCT sessions), a subgroup of patients will be explored, in the context of a pilot study, the TMS-EEG correlates of the change in symptomatology depression, which can be correlated with the different proposed therapeutic interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: tDCSAdministration of active tDCS, not followed by MCT session, but by a usual visit psychiatric follow-up |
| sham tDCS and MCT | No intervention | –Administration of sham tDCS, followed by MCT session |
| active tDCS and MCT | Experimental | Device: tDCSAdministration of active tDCS, followed by MCT session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide informed consent to study
- Ability to understand and speak the Italian language
- DSM-5 diagnosis of Major Depressive Disorder.
- Ongoing depressive episode of at least moderate intensity (HAM-D> 18)
Key exclusion criteria (15 listed)
- Previous tDCS sessions with significant side effects
- Positive personal history for seizures
- Positive family history for epileptic disease
- Positive personal history for neurological disease
- Positive personal history for head trauma with loss of consciousness
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 |
|---|---|---|
| tDCSTDCS is a noninvasive neurostimulation technique involving the transcranial application of a low-amperage electric current at a region of the cerebral cortex involved in the pathogenesis of major depression, the dorsolateral prefrontal cortex. In healthy subjects, the administration of excitatory tDCS on the left DLPFC improves the regulation of attention on information characterized by negative emotions, as does the administration of inhibitory tDCS on the DLPFC Right tDCS produces small changes in the neuronal membrane potential, thus increasing or decreasing the excitability of the stimulated tissue. Simultaneous administration to behavioral tasks designed to activate the stimulated cortical region should achieve a synergistic, amplifying the plasticity stimulated by the task. | Device | Active tDCS, active tDCS and MCT |
Primary outcome
to evaluate the potential superiority, from the point of view of therapeutic efficacy in depression, of the approach of combined administration of tDCS and MCT, compared with interventions based tDCS alone or MCT alone.
Time frame: end of treatment, 1, 3, 6 and 12 months
Change in the Hamilton Depression Rating Scale will be used as parameters, during follow-up (end of treatment, 1, 3, 6 and 12 months).
1 secondary outcome
To evaluate the TMS-EEG correlates of change in depressive symptomatology, correlating them with the different proposed therapeutic interventions, in a subgroup of patients recruited, in the context of a pilot study.
Time frame: 12 months
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 19 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Major Depressive Disorder, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 4 inclusion and 15 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 19 May 2023. 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 Italy. 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. 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?
to evaluate the potential superiority, from the point of view of therapeutic efficacy in depression, of the approach of combined administration of tDCS and MCT, compared with interventions based tDCS alone or MCT alone. (time frame: end of treatment, 1, 3, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2023.