DepressionNCT03897699
Mindful Breathing and tDCS for Depression
A study testing Transcranial Direct Current Stimulation and Mindful Breathing in people with Depression and Depressive Disorder, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Depression, Depressive Disorder
- What is being tested?
- Transcranial Direct Current Stimulation and Mindful Breathing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Mindful Breathing and Neuromodulation for Depression in Young People
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.
Read the 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.
- Conditions
- Depression, Depressive Disorder
- Being tested
- Transcranial Direct Current Stimulation, Mindful Breathing, Sham
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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.
Mindful BreathingBehavioural
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.
ShamOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Mindful Breathing; Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 weeks from baseline
Secondary outcomes (7)
Change in Depression MADRS-S
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.
Measured: Baseline and 5 weeks
Change in Mindfulness MAAS
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". Previous study reported that the MAAS was internally consistent and a reliable measure. MAAS score ranges from 1 to 6, with a higher score indicating 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.
Measured: Baseline and 9 weeks
Change in Rumination RRS
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.
Total scores range from 22 to 88.
Measured: Baseline and 9 weeks
Change in Mindfulness FMI
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.
Total scores range from 14 to 56.
Measured: Baseline and 9 weeks
Safety: Serious and Non-Serious Adverse Events
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.
Measured: 9 weeks
Tolerability: Enrollment and Drop-Out
Number of participants enrolled. A high number of participants enrolled will indicate a higher level of tolerability of the treatment.
Measured: 9 weeks
Tolerability: Drop-Out
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.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897699
- Sponsor's protocol ID
- PSYCH-2018-26861
- Status last verified
- Dec 2022
- First submitted
- 28 Mar 2019
- Last updated
- 13 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Breathing and Neuromodulation for Depression in Young People
- ClinicalTrials.gov ID
- NCT03897699
- Acronym / sponsor ID
- PSYCH-2018-26861
- Conditions
- Depression, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 13 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS + Mindful Breathing Training | Experimental | Device: Transcranial Direct Current Stimulation, Behavioral: Mindful Breathing20 minutes of active or sham stimulation will be applied at 2.0 mA in parallel with mindful breathing training |
| sham tDCS + Mindful Breathing Training | Sham comparator | Behavioral: Mindful Breathing, Other: ShamThe sham condition will apply stimulation only for the first and last 30 seconds of the 20-minute session |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Transcranial Direct Current StimulationA 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. | Device | active tDCS + Mindful Breathing Training |
| Mindful BreathingMBT 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. | Behavioural | active tDCS + Mindful Breathing Training, sham tDCS + Mindful Breathing Training |
| ShamWeak 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. | Other | sham tDCS + Mindful Breathing Training |
Primary outcome
Change in DLPFC Connectivity: Amygdala
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: 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.
Change in DLPFC Connectivity: DMN
Time frame: 5 weeks from baseline
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.
7 secondary outcomes
Change in Depression MADRS-S
Time frame: Baseline and 5 weeks
Change in Mindfulness MAAS
Time frame: Baseline and 9 weeks
Change in Rumination RRS
Time frame: Baseline and 9 weeks
Change in Mindfulness FMI
Time frame: Baseline and 9 weeks
Safety: Serious and Non-Serious Adverse Events
Time frame: 9 weeks
Tolerability: Enrollment and Drop-Out
Time frame: 9 weeks
Tolerability: Drop-Out
Time frame: 9 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Transcranial Direct Current Stimulation and Mindful Breathing in people with Depression and Depressive Disorder, run by University of Minnesota at 1 site in United States.
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 16 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 13 Jan 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in DLPFC Connectivity: Amygdala (time frame: Baseline and 5 week). The study lists 2 primary outcomes in all. 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 13 Jan 2023.