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Mindful Breathing and tDCS for Depression

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ClinicalTrials.gov Identifier: NCT03897699
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
Change in DLPFC Connectivity [ Time Frame: Baseline and 5 week ]
Change in dorsolateral prefrontal cortex connectivity with the salience network and the default mode using functional MRI compared between treatment groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03897699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Change in Depression MADRS-S [ Time Frame: Baseline and 5 weeks ]
    Montgomery-Åsberg Depression Rating Scale - self-assessment (MADRS-S) measures change in severity of depression symptoms over time. Treatment response will be measured using the MADRS-S and a ~50% reduction in depression severity, i.e. total MADRS-S score, will indicate a positive response to treatment. The scale includes 9 items that are rated by participants on a 4-point Likert scale ranging from 0 - 3. Half-point scores are also possible, i.e 0.5, 1.5, 2.5. Participants rate their symptoms from over the past 3 days and the range of total possible scores is 0 - 27, with a higher score indicating greater severity of symptoms. Bondolfi et al. (2010) found good internal consistency for the MADRS-S, as well as good concurrent validity between the MADRS (clinician administered) and the MADRS-S. Lastly, the MADRS-S was found to be sensitive to change in depression symptoms over time.
  • Change in Mindfulness MAAS [ Time Frame: Baseline and 9 weeks ]
    Mindful Attention and Awareness Scale (MAAS) measures presence or absence of awareness of what is happening in the present . The MAAS consists of 15 items. Participants are requested to rate each item according to a 6-point Likert scale with the following options: "Almost Always", "Very Frequently", "Somewhat Frequently", "Somewhat Infrequently", "Very Infrequently", and "Almost Never". Brown & Ryan (2003) reported that the MAAS was internally consistent and a reliable measure. A higher score on the MAAS indicates a greater awareness of inner experiences and mindfulness. In the present study, an increase in the total MAAS score would indicate an increase in presence of awareness of what is happening in the present.
  • Change in Rumination RRS [ Time Frame: Baseline and 9 weeks ]
    Ruminative Response Scale (RRS) measures rumination, which refers to thoughts and behaviors centered around one's symptoms and their causes, as well as potential consequences. Nolen-Hoeksema, Morrow, & Fredrickson (1993) reported that ruminative thoughts correlated with depressed mood. They further reported a consistency in ruminative responses over a 30-day period. The RRS will be used to measure changes in rumination in the present study. The measure consists of a total of 22 statements that describe ruminative thoughts and participants are requested to rate each statement on a scale of 1 - 4, 1 being "Almost Never" and 4 being "Almost Always". Change in rumination corresponds with a change in the total RRS score.
  • Change in Mindfulness FMI [ Time Frame: Baseline and 9 weeks ]
    Freiburg Mindfulness Inventory (FMI) assesses curious attitude toward the mindfulness experience. The FMI contains 14 statements related to mindfulness experiences. Participants are requested to rate each statement according to a 4-point Likert scale ranging from "Rarely" to "Almost Always". An increase in the FMI total score would indicate an increase in mindfulness. Walach et al. (2006) reported that the FMI is a valid and reliable measure of mindfulness.
  • Safety: Serious and Non-Serious Adverse Events [ Time Frame: 9 weeks ]
    Measure of occurrence of negative side-effects from treatment. Side effects will be collected via participant self-report. Number of serious and non-serious adverse events will be considered in determining safety of the treatment. A higher number of adverse events will indicate lower treatment safety.
  • Tolerability: Enrollment and Drop-Out [ Time Frame: 9 weeks ]
    Number of participants enrolled. A high number of participants enrolled will indicate a higher level of tolerability of the treatment.
  • Tolerability: Drop-Out [ Time Frame: 9 weeks ]
    Number of participants who drop-out due to inability to tolerate treatment. A high number of participant drop-outs will indicate a lower level of tolerability of the treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindful Breathing and tDCS for Depression
Official Title  ICMJE Mindful Breathing and Neuromodulation for Depression in Young People
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.
Detailed Description

Aim 1: To demonstrate the feasibility of recruiting and randomizing adolescents with depression to a research protocol involving MBT and tDCS. The investigators expect that adolescents will be willing to enroll in a randomized trial involving MBT and tDCS.

Aim 2: To test the tolerability of MBT and tDCS in adolescents. The investigators expect that MBT will be well-tolerated and that active tDCS will show no difference in tolerance compared to sham stimulation.

Aim 3: To examine whether tDCS can enhance the effects of MBT. The investigators expect the MBT + tDCS group will show greater reduction in depressive symptoms compared to the MBT + sham stimulation group.

Aim 4: To examine the mechanisms of MBT +/- tDCS treatment. The investigators expect that depression symptom improvement will be associated with decreased rumination, improvements in emotion regulation, increased task-based and resting state DLPFC-DMN and DLPFC-amygdala connectivity, as well as increased DLPFC activation and reduced amygdala activation during rumination and emotion processing tasks. The investigators also expect reduced alpha asymmetry and reduced LPP amplitude during emotion regulation and emotion processing. The investigators expect these changes will be greatest in the active tDCS + MBT group.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Depressive Disorder
Intervention  ICMJE
  • Device: Transcranial Direct Current Stimulation
    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.
  • Behavioral: Mindful Breathing
    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.
  • Other: Sham
    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.
Study Arms  ICMJE
  • Experimental: active tDCS + Mindful Breathing Training
    20 minutes of active or sham stimulation will be applied at 2.0 mA in parallel with mindful breathing training
    Interventions:
    • Device: Transcranial Direct Current Stimulation
    • Behavioral: Mindful Breathing
  • Sham Comparator: sham tDCS + Mindful Breathing Training
    The sham condition will apply stimulation only for the first and last 30 seconds of the 20-minute session
    Interventions:
    • Behavioral: Mindful Breathing
    • Other: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Refusal to cooperate with study procedures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kathryn Cullen, MD 612-273-9732 rega0026@umn.edu
Contact: Michelle Thai 612-626-6870 umnteen@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897699
Other Study ID Numbers  ICMJE STUDY00004214
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP