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

NCT03548545 | Unknown

• 1 other identifier: SECVS 174/2017
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; CBT; Transcranial Direct Current Stimulation

Keywords

MDD; CBT; tDCS

Outcome Measures

Primary Outcomes (1)

• Mood improvement

  Mood as assessed by the Montgomery-Asberg Depression Rating Scale(MADRS)

  Improvement defined as 50% decrease in the MADRS score at 4-week intervention. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.

Secondary Outcomes (1)

• EEG activity

  Reduction of the inter-hemispheric imbalance over DLPFC at 4-week post-intervention sessions

Study Arms (2)

CBT combined with active tDCS

EXPERIMENTAL

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

Device: tDCS

CBT combined with sham tDCS

SHAM COMPARATOR

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

Device: tDCS

Interventions

tDCS 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.

Also known as: CBT

CBT combined with active tDCS; CBT combined with sham tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• )Any contraindication to receive tDCS(such as metal in the head, implanted brain medical devices);
• )any significant or unstable neurologic or psychiatric disorder other than MDD;2) history of substance abuse within the past 6-months;
• )Any personality disorders; and
• )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.

Sponsors & Collaborators

• University of Minho: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

School of Psychology, University of Minho

Braga, 4710-057, Portugal

RECRUITING

Related Publications (1)

• 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.

  PMID: 33240121 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Sandra R Carvalho, PhD

  Cipsi, School of Psychology, University of Minho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both the Participant, the outcome assessor and the Psychologist providing the CBT will be blinded to the type of the stimulation that the subject is receiving. Unblinding will occur at the end of the participation in the study and subjects that received sham tDCS will have the chance to receive the active tDCS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This is a parallel randomized, double blinded, sham controlled clinical trial in which a total of 72 MDD subjects(36 per arm) will be randomized to one of two groups: CBT combined with either active or sham tDCS.

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: June 7, 2018
• Study Start: March 28, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

PT (1)