tDCS as add-on Treatment to Cognitive-Behavior Therapy in People With MDD

NCT ID: NCT03548545

Last Updated: 2018-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-28
• Study Completion Date: 2020-12-31

Brief Summary

This is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 drug-naïve MDD subjects (36 per arm) are randomized to one of two groups: Cognitive-Behavior Therapy (CBT) combined with either active or sham tDCS.

The primary outcome is mood improvement, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The secondary outcome is to test whether tDCS combined with CBT can engage the proposed mechanistic target, of restoring the prefrontal imbalance and connectivity, by changes over EEG.

Detailed Description

Major Depression Disorder (MDD) is widely recognized as a staggering global healthcare challenge, as well as a potentially lethal illness. In Portugal, 7% of the population is diagnosed with depression every year, and suicide is responsible for more than a thousand deaths annually.

The current standard care for MDD involves the use of psychotherapy, antidepressant medication, or a combination of both. However, approximately 30% of people suffering from MDD exhibit depressive symptoms despite the appropriate psychological and pharmacological treatments. One option is to combine several treatments, usually by the use of drug augmentations and/or combinations of different drugs, which often increases the risk of adverse effects. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters.

Cognitive-behavioral Therapy (CBT) is a well-established, and empirically-supported non-pharmacological treatment for depression, including for those that have not responded to antidepressants. However, several patients remain refractory to CBT.

tDCS is a safe, non-invasive, rather inexpensive, easy to administrate, and well-tolerated neuromodulatory technique. Several studies, including studies from our group, already shown that tDCS can be effective in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other intervention.

What is not known so far are the effects of using tDCS as add-on intervention to CBT on MDD symptoms.

Therefore, this is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 first-episode MDD subjects (36 per arm) will be randomized to one of two groups: CBT combined with either active or sham tDCS. The design and the tDCS parameters will be similar to the SELECT trial by Brunoni et al. (2013).

The primary outcome is mood improvement, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The secondary outcome is to test whether tDCS combined with CBT can engage the proposed mechanistic target, of restoring the prefrontal imbalance and connectivity, by changes over resting-state EEG and fMRI.

Conditions

Major Depressive Disorder; CBT; Transcranial Direct Current Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CBT combined with active tDCS

Subjects allocated to this arm will receive cognitive-behavior therapy combined with active tDCS over the dorsolateral prefrontal cortex.

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

subjects will receive a total of 8-structured CBT sessions administered by a certified therapist(according to the NICE guidelines).In the first two weeks, participants will undergo 6-sessions of CBT every other day(3 CBT sessions per week) and 10 daily sessions of either active or sham tDCS(2 mA, 30 minutes).They will undergo additional booster sessions of the same intervention(active or sham tDCS followed by CBT) by week 4 and 6.

CBT combined with sham tDCS

Subjects allocated to this arm will receive cognitive-behavior therapy combined with sham tDCS over the dorsolateral prefrontal cortex.

Group Type: SHAM_COMPARATOR

tDCS

Intervention Type: DEVICE

subjects will receive a total of 8-structured CBT sessions administered by a certified therapist(according to the NICE guidelines).In the first two weeks, participants will undergo 6-sessions of CBT every other day(3 CBT sessions per week) and 10 daily sessions of either active or sham tDCS(2 mA, 30 minutes).They will undergo additional booster sessions of the same intervention(active or sham tDCS followed by CBT) by week 4 and 6.

Interventions

tDCS

subjects will receive a total of 8-structured CBT sessions administered by a certified therapist(according to the NICE guidelines).In the first two weeks, participants will undergo 6-sessions of CBT every other day(3 CBT sessions per week) and 10 daily sessions of either active or sham tDCS(2 mA, 30 minutes).They will undergo additional booster sessions of the same intervention(active or sham tDCS followed by CBT) by week 4 and 6.

Intervention Type: DEVICE

Other Intervention Names

CBT

Eligibility Criteria

Inclusion Criteria

• 1)Aged 18-75 years;
• 2)Unipolar, nonpsychotic MDD;
• 3)Score in the MADRS between 7 and 34(mild to moderate depression);
• 4)Low risk of suicide;
• 5)Able to sign informed consent

Exclusion Criteria

• 1)Any contraindication to receive tDCS(such as metal in the head, implanted brain medical devices);
• 2)any significant or unstable neurologic or psychiatric disorder other than MDD;2) history of substance abuse within the past 6-months;
• 3)Any personality disorders; and
• 5)any severe life-threatening Axis III disorders or concurrent medical condition likely to worsen patient's functional status in next 6-months such as; cancer, terminal heart, kidney, or liver disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role: collaborator

University of Minho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Carvalho

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra R Carvalho, PhD

Role: PRINCIPAL_INVESTIGATOR

Cipsi, School of Psychology, University of Minho

Locations

School of Psychology, University of Minho

Braga, , Portugal

Site Status: RECRUITING

Countries

Portugal

Facility Contacts

Sandra Carvalho, PhD

Role: primary

sandrarc@psi.uminho.pt

+351253604661

References

Carvalho S, Goncalves OF, Brunoni AR, Fernandes-Goncalves A, Fregni F, Leite J. Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naive Major Depression Patients: The ESAP Study Protocol. Front Psychiatry. 2020 Nov 3;11:563058. doi: 10.3389/fpsyt.2020.563058. eCollection 2020.

Reference Type: DERIVED

PMID: 33240121 (View on PubMed)

Other Identifiers

SECVS 174/2017

Identifier Type: -

Identifier Source: org_study_id