Depression
Conditions
Brief summary
Depression and other psychiatric conditions are marked by exaggerated, preferential processing (or attention bias) of negative information relative to neutral or positive information. This depression-related attention bias can be measured using the Dot Probe task and Visual Search, that allow assessment of the degree to which one shows bias toward negative information in the presence of neutral or positive information. A clinically effective treatment for depression is noninvasive brain stimulation with transcranial direct current stimulation (tDCS), targeting the dorsolateral prefrontal cortex (DLPFC), delivered in repeated sessions across a period of time. The study will test the effect of a single session of DLPFC tDCS on attention bias in patients with mild to moderate depression.
Detailed description
This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to moderate depression (based on BDI-II score range 14-19 for mild and 20-28 for moderate) to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression. Subjects may or may not be receiving treatment for mild-moderate depression.
Interventions
DEVICETranscranial direct current stimulation (tDCS)
Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-45 * Female * Mild to moderate depression (determined by BDI-II scores of 14-19 and 20-28, respectively) * If taking antidepressants, medication must be stable ≥ 30 days prior to screening
Exclusion criteria
* Wide-Range Achievement Test-Fourth Edition (WRAT-4) Reading Subtest standard score \<85 (to ensure understanding of test procedures) * Insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff * Primary psychiatric disorder other than depression (based on MINI) * Primary neurologic condition that would prevent ability to participate (as determined by study clinician). * History of head trauma in the last year * Medical device implants in the head or neck * History or current uncontrolled seizure disorder * Current substance abuse disorder * . Pregnant or lactating women * Skin disorder/sensitive skin near stimulation locations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI-II) Score | Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour) | Measured by the Beck Depression Inventory (BDI-II) which is a brief, criteria-referenced assessment for measuring depression severity. The BDI-II consists of 21 items to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The items are scored as 0, 1, 2, or 3. The score range is 0-63. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression. |
| Analog Mood Scale (AMS) Anxiety Score | Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour) | Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking How anxious are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety. |
| Analog Mood Scale (AMS) Sad Score | Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour) | Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking How sad are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness. |
| Analog Mood Scale (AMS) Happy Score | Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour) | Analog Mood Scale (AMS) Happy is a brief measure of positive and negative mood asking How happy are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of happiness. |
| Change in Analog Mood Scale (AMS) Anxiety Score | Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour) | Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking How anxious are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety. The AMS Anxiety will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Anxiety scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less anxiety post-tDCS administration. A negative value indicates increased anxiety post-tDCS administration. |
| Change in Analog Mood Scale (AMS) Sad Score | Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour) | Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking How sad are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness. The AMS Sad will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Sad scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less sadness post-tDCS administration. A negative value indicates increased sadness post-tDCS administration. |
| Change in Normalized Response Time | Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour) | The Visual Search task will be administered to further assess attention bias, particularly examining the interference and facilitation effects in attention using emotional stimuli. The task uses emotional faces or words as stimuli, where the participant is instructed to search for the face that does not fit into the search set with respect to gender, where the target and distractors are expressing different or same emotions. This study will use this task as an outcome measure of Attention Bias. For this task, the change in mean response time (the time between display onset and button press) to the target stimulus is measured as the main outcome variable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Female Participants With Depression Female participants with mild to moderate depression to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression.
Transcranial direct current stimulation (tDCS): Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation) | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Female Participants With Depression |
|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 6.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Analog Mood Scale (AMS) Anxiety Score
Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking How anxious are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety.
Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female Participants With Depression | Analog Mood Scale (AMS) Anxiety Score | 7.95 score on a scale | Standard Deviation 5.75 |
Primary
Analog Mood Scale (AMS) Happy Score
Analog Mood Scale (AMS) Happy is a brief measure of positive and negative mood asking How happy are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of happiness.
Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female Participants With Depression | Analog Mood Scale (AMS) Happy Score | 11.67 score on a scale | Standard Deviation 6.16 |
Primary
Analog Mood Scale (AMS) Sad Score
Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking How sad are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness.
Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female Participants With Depression | Analog Mood Scale (AMS) Sad Score | 7.19 score on a scale | Standard Deviation 5.1 |
Primary
Beck Depression Inventory (BDI-II) Score
Measured by the Beck Depression Inventory (BDI-II) which is a brief, criteria-referenced assessment for measuring depression severity. The BDI-II consists of 21 items to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The items are scored as 0, 1, 2, or 3. The score range is 0-63. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female Participants With Depression | Beck Depression Inventory (BDI-II) Score | 21.29 score on a scale | Standard Deviation 5.29 |
Primary
Change in Analog Mood Scale (AMS) Anxiety Score
Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking How anxious are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety. The AMS Anxiety will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Anxiety scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less anxiety post-tDCS administration. A negative value indicates increased anxiety post-tDCS administration.
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female Participants With Depression | Change in Analog Mood Scale (AMS) Anxiety Score | 2.76 score on a scale | Standard Deviation 2.8 |
Primary
Change in Analog Mood Scale (AMS) Sad Score
Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking How sad are you?. Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness. The AMS Sad will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Sad scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less sadness post-tDCS administration. A negative value indicates increased sadness post-tDCS administration.
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female Participants With Depression | Change in Analog Mood Scale (AMS) Sad Score | 2.62 score on a scale | Standard Deviation 2.7 |
Primary
Change in Normalized Response Time
The Visual Search task will be administered to further assess attention bias, particularly examining the interference and facilitation effects in attention using emotional stimuli. The task uses emotional faces or words as stimuli, where the participant is instructed to search for the face that does not fit into the search set with respect to gender, where the target and distractors are expressing different or same emotions. This study will use this task as an outcome measure of Attention Bias. For this task, the change in mean response time (the time between display onset and button press) to the target stimulus is measured as the main outcome variable.
Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Female Participants With Depression | Change in Normalized Response Time | -0.39 milliseconds | Standard Deviation 0.6 |