Mindful Breathing and tDCS for Depression

NCT03897699 | Completed Results FDA Device

• 1 other identifier: PSYCH-2018-26861
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (DLPFC) can enhance the therapeutic effect of mindful breathing training (MBT) for adolescent depression. The objective is to enhance connectivity between the DLPFC with the amygdala and Default Mode Network (DMN) circuits as well as to enhance emotion regulation abilities and decrease rumination to reduce symptoms of depression. This will aid in the development of novel treatments for depression.

Conditions

Depression; Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Change in DLPFC Connectivity: Amygdala

  Change in dorsolateral prefrontal cortex connectivity with the salience network and the default mode using functional MRI compared between treatment groups: Right Amygdala and left DLPFC. Lower connectivity may represent a reduced tendency to engage in maladaptive, repetitive negative thinking. For r-values, 0 represents that the timeseries of the respective ROIs are not correlated. A better outcome may be indexed by lower connectivity (e.g., negative R values), which may represent a greater ability of the DLPFC to downregulate the amygdala and, which in turn may reduce the tendency to engage in maladaptive, repetitive negative thinking.

  Baseline and 5 week

• Change in DLPFC Connectivity: DMN

  Change in dorsolateral prefrontal cortex connectivity with the salience network and the default mode using functional MRI compared between treatment groups: default mode network and left DLPFC. Lower DLPFC and DMN connectivity may represent adaptive switching between thinking states to focus on a task at hand or to engage in more reflective, introspective thinking patterns. For r-values, 0 represents that the timeseries of the respective ROIs are not correlated. Change in dorsolateral prefrontal cortex connectivity with the salience network and the default mode using functional MRI compared between treatment groups: default mode network and left DLPFC. A better outcome may be indexed by lower DLPFC and DMN connectivity (e.g., negative R values), which may represent adaptive switching between thinking states to focus on a task at hand or to engage in more reflective, introspective thinking patterns.

  5 weeks from baseline

Secondary Outcomes (7)

• Change in Depression MADRS-S

  Baseline and 5 weeks

• Change in Mindfulness MAAS

  Baseline and 9 weeks

• Change in Rumination RRS

  Baseline and 9 weeks

• Change in Mindfulness FMI

  Baseline and 9 weeks

• Safety: Serious and Non-Serious Adverse Events

  9 weeks

Study Arms (2)

active tDCS + Mindful Breathing Training

EXPERIMENTAL

20 minutes of active or sham stimulation will be applied at 2.0 mA in parallel with mindful breathing training

Device: Transcranial Direct Current Stimulation; Behavioral: Mindful Breathing

sham tDCS + Mindful Breathing Training

SHAM COMPARATOR

The sham condition will apply stimulation only for the first and last 30 seconds of the 20-minute session

Behavioral: Mindful Breathing; Other: Sham

Interventions

Transcranial Direct Current Stimulation DEVICE

A non-invasive neuromodulation technique that can modulate neural activity. Weak electrical current (\~2mA) is applied to the scalp using anodal and cathodal electrode sponges, which increase or decrease cortical excitability respectively.

active tDCS + Mindful Breathing Training

Mindful Breathing BEHAVIORAL

MBT is a mindfulness-based intervention that guides participants to pay attention to the present experience. Participants will be trained to become aware of mind-wandering, disengage, and shift attention back to the present experience. Participants will practice mindful breathing using a computerized application that they will be able to access on the web.

active tDCS + Mindful Breathing Training; sham tDCS + Mindful Breathing Training

Sham OTHER

Weak electrical current (\~2mA) is applied to the scalp using anodal and cathodal electrode sponges, which increase or decrease cortical excitability respectively. Sham stimulation will serve as a control condition with current applied only for the first and last 30 seconds of the 20-minute session.

sham tDCS + Mindful Breathing Training

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of major depressive disorder (MDD), Dysthymia, or Other specified/Unspecified Depressive Disorder based on MINI.
• Experiencing current symptoms of depression as indexed by a MADRS-S score ≥ 13
• Ability to access the MBT online-based application (e.g., on a personal laptop, tablet, or cell phone)
• Fluent in English

You may not qualify if:

• Any participant with a clinically defined neurological disorder or insult including, but not limited to, a condition likely to increase the risk of seizure; such as, space occupying brain lesion; any history of seizure; history of cerebrovascular accident; transient ischemic attack within two years; cerebral aneurysm; dementia; brain surgery; history or stroke or family history of epilepsy
• Any participant with an increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure or history of significant head trauma with loss of consciousness for ≥ 5 minutes
• Participants with conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head excluding the mouth that cannot safely be removed. Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes
• Participants with active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, and vagus nerve stimulators
• Participants with pre-existing sores or lesions at the site of tDCS or EEG electrode placement
• A hair style that would impede EEG and tDCS electrode contact (e.g., dread locks)
• Any participant with a current or possibility of current pregnancy
• Participants unable to give informed consent.
• Participation in any investigational drug trial within 4 weeks of the baseline visit
• Clinically significant laboratory abnormality or medical condition, that in the opinion of the investigator would hinder the participant in completing the procedures required by the study
• Currently actively suicidal with intent and plan determined by the C-SSRS at the baseline visit.
• A diagnosis of current or recent substance use disorder (within the past 12 months)
• A diagnosis of Schizophrenia, Bipolar Disorder, or Autism
• Unstable psychotherapy (therapy must be for at least 3 months prior to entry into the study, with no anticipation of change in the frequency or treatment focus of the therapeutic sessions over the duration of the study)
• Recent change in dose of antidepressant medication (within 6 weeks prior to entry into the study). This includes all antidepressants and any adjunctive psychotropic medications that are being used to address problems related to mood or anxiety (e.g. antipsychotic medications, mood stabilizers)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder

Interventions

Transcranial Direct Current Stimulation; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Kathryn Cullen
• Organization: University of Minnesota

rega0026@umn.edu

612-273-9732

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 1, 2019
• Study Start: March 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 13, 2023
• Results First Posted: January 13, 2023

Record last verified: 2022-12

Locations

US (1)