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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression MADRS-S | Montgomery-Ã…sberg 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. 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. |
| FG001 | Sham tDCS + Mindful Breathing Training | The sham condition will apply stimulation only for the first and last 30 seconds of the 20-minute session 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | r-value | Baseline and 5 week |
|
Adverse event data were collected over a 9 week period per participant starting at baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathryn Cullen | University of Minnesota | 612-273-9732 | rega0026@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2021 | Oct 2, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2021 | Aug 11, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| 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. |
|
| 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 9 weeks |
| BG001 | Sham tDCS + Mindful Breathing Training | The sham condition will apply stimulation only for the first and last 30 seconds of the 20-minute session 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sham tDCS + Mindful Breathing Training | The sham condition will apply stimulation only for the first and last 30 seconds of the 20-minute session 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. 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | r-value | 5 weeks from baseline |
|
|
|
| Secondary | Change in Depression MADRS-S | Montgomery-Ã…sberg 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 5 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | number on a scale | Baseline and 9 weeks |
|
|
|
| Secondary | 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. | Posted | Number | adverse events | 9 weeks |
|
|
|
| Secondary | 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. | Posted | Number | participants | 9 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 9 weeks |
|
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|
| 0 |
| 21 |
| 0 |
| 21 |
| 21 |
| 21 |
| EG001 | Sham tDCS + Mindful Breathing Training | The sham condition will apply stimulation only for the first and last 30 seconds of the 20-minute session 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. 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. | 0 | 22 | 0 | 22 | 22 | 22 |
| unusual feelings on skin of head | General disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| tingling | General disorders | Systematic Assessment |
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| itchiness | General disorders | Systematic Assessment |
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| sleepliness | General disorders | Systematic Assessment |
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| difficulty paying attention | General disorders | Systematic Assessment |
|
| unusual feelings, attitude, emotions | Psychiatric disorders | Systematic Assessment |
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| tooth pain | General disorders | Systematic Assessment |
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| change in hearing | Ear and labyrinth disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| twitches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| anxiety/worry/nervousness | Psychiatric disorders | Systematic Assessment |
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| forgetfulness | General disorders | Systematic Assessment |
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| balance issue | General disorders | Systematic Assessment |
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| hand movement change | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| abnormal sleep | General disorders | Systematic Assessment |
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| muscle knot/ right shoulder stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bike accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |