Suicidal Ideation
Conditions
Brief summary
Risk for suicide is elevated in the period after discharge from hospital among adults with major affective disorder. The primary objective of this study is to investigate the feasibility of delivering tDCS sessions for high-risk patients for suicide at home in the days following discharge from an emergency department or inpatient unit. This is a single-center, randomized, sham-controlled, double-blind clinical study. We plan to assess up to 80 adult patients for eligibility over 12 months of which 20 will be enrolled and randomized. Clinical assessments will be performed at baseline, post-treatment day 14 (14 days after the first tDCS session), and follow-up day 30 and 60 (30 and 60 days after the first tDCS session, respectively).
Interventions
Each participant will be asked to do ten home-based tDCS sessions, one per weekday, during two weeks (Monday to Friday). Each session will be supervised remotely by a member of the research staff via HIPAA-compliant videoconference. Participants will receive active home-based tDCS (constant current intensity of 2mA) anodal-left and cathodal-right prefrontal for 30 minutes per session daily for 2 weeks (Monday to Friday - 10 sessions overall) via a tDCS stimulator with headgear and 5x7 (35cm2) saline-soaked surface sponge electrodes.
DEVICESham home-based transcranial direct current stimulation (tDCS)
Each participant will be asked to do ten home-based sessions, one per weekday, during two weeks (Monday to Friday). Each session will be supervised remotely by a member of the research staff via HIPAA-compliant videoconference. Participants will receive sham home-based tDCS for 30 minutes per session daily for 2 weeks (Monday to Friday - 10 sessions overall) via a tDCS stimulator with headgear and 5x7 (35cm2) saline-soaked surface sponge electrodes.
Sponsors
University of Rochester
Brain & Behavior Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age between 18 and 65 years * diagnosis of mood or bipolar disorder registered in the electronic hospital medical record * history of suicidal ideation and/or suicidal behavior at the time of admission registered in the electronic hospital medical record * absent of suicidal ideation at the time of enrollment (defined as questions 1 and 2 of the C-SSRS answered "no") * ability and willingness to provide information and permission to contact at least one person in the case of a need to contact them to promote subject safety or inability to reach the subject for follow-up * a living situation with access to a private space suitable for the administration of the RS-tDCS sessions in the next three weeks * agree to use a medically acceptable form of birth control while receiving the treatment if you are an individual able to become pregnant * living in Monroe County region, as this is the area covered by the Mobile Crisis Team, a URMC psychiatric emergency team serving anyone within Monroe County * device or computer with internet access for a URMC-approved remote RS-tDCS supervision * ability to manage proper use of the device in a practice session
Exclusion criteria
* acute psychiatric instability or substance abuse (e.g., psychotic symptoms, alcohol misuse in the previous three months, use of any illicit drugs in the previous three months) * unstable medical condition with reduction of functional capacity * history of epilepsy or seizures in the last year * history of neurodegenerative diseases registered in the electronic hospital medical record * presence of or implanted any ferromagnetic metal in the head or the neck * pregnant or breastfeeding or willingness to become pregnant in the next month * history of head trauma (e.g., head injury, brain injury) or neurosurgery * history of skin disorder or sensitive skin area near stimulation locations * the presence of pacemaker * current treatment with electroconvulsive therapy or transcranial magnetic stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions | 14 days after start of treatment | Number of completed remotely supervised transcranial direct current stimulation (RS-tDCS) sessions, for both active and sham groups: We expect at least 70% of the subjects to complete at least 5 of recommended 10 RS-tDCS sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 14 | day 14 [+ 7 days] from the first RS-tDCS session | The C-SSRS (Columbia-Suicide Severity Rating Scale) is a suicidal ideation and behavior rating scale. For the 5 items assessing suicidal ideation intensity, each item is scored 0-5. The total intensity score is the sum of these 5 items (range 0-25), with higher scores indicating greater suicidal ideation. The mean is calculated by the sum of the scores of the participants at Day 14 divided by the number of participants |
| Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 30 | Day 30 (± 7 days) from the first RS-tDCS session | The C-SSRS (Columbia-Suicide Severity Rating Scale) is a suicidal ideation and behavior rating scale. For the 5 items assessing suicidal ideation intensity, each item is scored 0-5. The total intensity score is the sum of these 5 items (range 0-25), with higher scores indicating greater suicidal ideation. The mean is calculated by the sum of the scores of the participants at Day 30 divided by the number of participants |
| Mean Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Day 60 | Day 60 (± 10 days) from the first RS-tDCS session | Outcome measure description: The C-SSRS (Columbia-Suicide Severity Rating Scale) is a suicidal ideation and behavior rating scale. For the 5 items assessing suicidal ideation intensity, each item is scored 0-5. The total intensity score is the sum of these 5 items (range 0-25), with higher scores indicating greater suicidal ideation. The mean is calculated by the sum of the scores of the participants at Day 60 divided by the number of participants |
| Acceptability of the Intervention as Assessed by Participant-reported Questionnaire | Collected after the final RS-tDCS session (tenth session) | Acceptability of the intervention is assessed based on participants' readiness, self-confidence, and satisfaction with treatment. Specifically, acceptability is determined if at least 60% of participants respond "Strongly agree" or "Agree" to item 11 of the acceptability questionnaire: "Overall, I felt that transcranial electrical stimulation treatment benefited me." The questionnaire uses a 5-point Likert scale: "Strongly agree," "Agree," "Neither agree nor disagree," "Disagree," "Strongly disagree." Higher scores indicate greater perceived acceptability. |
| Proportion of Patients With no Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) | day 14 [+ 7 days] from the first RS-tDCS session | Proportion of participants who report no suicidal ideation, defined as answering "No" to both question 1 ("Have you wished you were dead or wished you could go to sleep and not wake up?") and question 2 ("Have you actually had any thoughts of killing yourself?") on the C-SSRS. Higher proportions indicate fewer participants experiencing suicidal ideation. |
| Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS | day 30 [+ 7 days] from the first RS-tDCS session | Proportion of participants who report no suicidal ideation, defined as answering "No" to both question 1 ("Have you wished you were dead or wished you could go to sleep and not wake up?") and question 2 ("Have you actually had any thoughts of killing yourself?") on the C-SSRS. Higher proportions indicate fewer participants experiencing suicidal ideation |
| Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 14 | day 14 [+ 7 days] from the first RS-tDCS session | The Ruminative Responses Scale (RRS) is a 22-item self-report measure assessing rumination. Each item is rated on a 4-point Likert scale: 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. The total score is calculated by summing the scores of all 22 items (range 22-88), with higher scores indicating greater rumination. The mean is calculated by the sum of the scores of the participants at Day 14 divided by the number of participants |
| Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 30 | day 30 [+ 7 days] from the first RS-tDCS session | The Ruminative Responses Scale (RRS) is a 22-item self-report measure assessing rumination. Each item is rated on a 4-point Likert scale: 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. The total score is calculated by summing the scores of all 22 items (range 22-88), with higher scores indicating greater rumination. The mean is calculated by the sum of the scores of the participants at Day 30 divided by the number of participants |
| Mean Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS) Day 60 | day 60 [+ 10 days] from the first RS-tDCS session | The Ruminative Responses Scale (RRS) is a 22-item self-report measure assessing rumination. Each item is rated on a 4-point Likert scale: 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. The total score is calculated by summing the scores of all 22 items (range 22-88), with higher scores indicating greater rumination. The mean is calculated by the sum of the scores of the participants at Day 60 divided by the number of participants |
| Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 14 | day 14 [+ 7 days] from the first RS-tDCS session | The Concise Associated Symptoms Tracking (CAST) scale is a 16-item self-report measure assessing symptoms associated with suicidal ideation across five domains: anxiety (3 items, subscore range 3-15), irritability (5 items, subscore range 5-25), mania (4 items, subscore range 4-20), insomnia (2 items, subscore range 2-10), and panic (2 items, subscore range 2-10). Total CAST scores range from 16 to 80. Each item is rated on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree. Higher scores indicate greater symptom severity. The mean is calculated by the sum of the scores of the participants at Day 14 divided by the number of participants |
| Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 30 | day 30 [+ 7 days] from the first RS-tDCS session | The Concise Associated Symptoms Tracking (CAST) scale is a 16-item self-report measure assessing symptoms associated with suicidal ideation across five domains: anxiety (3 items, subscore range 3-15), irritability (5 items, subscore range 5-25), mania (4 items, subscore range 4-20), insomnia (2 items, subscore range 2-10), and panic (2 items, subscore range 2-10). Total CAST scores range from 16 to 80. Each item is rated on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree. Higher scores indicate greater symptom severity. The mean is calculated by the sum of the scores of the participants at Day 30 divided by the number of participants |
| Mean Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale Day 60 | day 60 [+ 10 days] from the first RS-tDCS session | The Concise Associated Symptoms Tracking (CAST) scale is a 16-item self-report measure assessing symptoms associated with suicidal ideation across five domains: anxiety (3 items, subscore range 3-15), irritability (5 items, subscore range 5-25), mania (4 items, subscore range 4-20), insomnia (2 items, subscore range 2-10), and panic (2 items, subscore range 2-10). Total CAST scores range from 16 to 80. Each item is rated on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree. Higher scores indicate greater symptom severity. The mean is calculated by the sum of the scores of the participants at Day 60 divided by the number of participants |
| Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 14 | day 14 [+ 7 days] from the first RS-tDCS session | MADRS is a 10-item clinician-administered questionnaire assessing the following symptoms: 1) Apparent sadness, 2) Reported sadness, 3) Inner tension, 4) Reduced sleep, 5) Reduced appetite, 6) Concentration difficulties, 7) Lassitude, 8) Inability to feel, 9) Pessimistic thoughts, 10) Suicidal thoughts. Each item is scored 0-6, giving a total score range of 0-60. Higher scores indicate more severe depressive symptoms. The mean is calculated by the sum of the scores of the participants at Day 14 divided by the number of participants |
| Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 30 | day 30 [+ 7 days] from the first RS-tDCS session | MADRS is a 10-item clinician-administered questionnaire assessing the following symptoms: 1) Apparent sadness, 2) Reported sadness, 3) Inner tension, 4) Reduced sleep, 5) Reduced appetite, 6) Concentration difficulties, 7) Lassitude, 8) Inability to feel, 9) Pessimistic thoughts, 10) Suicidal thoughts. Each item is scored 0-6, giving a total score range of 0-60. Higher scores indicate more severe depressive symptoms. The mean is calculated by the sum of the scores of the participants at Day 30 divided by the number of participants |
| Mean Depression Severity as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Day 60 | day 60 [+ 10 days] from the first RS-tDCS session | MADRS is a 10-item clinician-administered questionnaire assessing the following symptoms: 1) Apparent sadness, 2) Reported sadness, 3) Inner tension, 4) Reduced sleep, 5) Reduced appetite, 6) Concentration difficulties, 7) Lassitude, 8) Inability to feel, 9) Pessimistic thoughts, 10) Suicidal thoughts. Each item is scored 0-6, giving a total score range of 0-60. Higher scores indicate more severe depressive symptoms. The mean is calculated by the sum of the scores of the participants at Day 60 divided by the number of participants |
| Mean Cumulative Side Effect Score Per Participant Across RS tDCS Sessions | Assessed after each RS-tDCS session; values reported represent the average and summarized across all sessions completed during the 4-week treatment period | After each RS tDCS session (up to 10 sessions per participant), seven prespecified side effects itching, burning, headache, fatigue, nervousness, dizziness, and difficulty concentrating were assessed using the RS tDCS Side Effect Rating Scale. Each symptom was rated on a numeric scale from 0 to 10, where 0 indicates not at all and 10 indicates the highest degree of severity. For each participant and each symptom, ratings were summed across all completed sessions to generate a cumulative symptom specific side effect score, with a theoretical range of 0 to 100. Higher scores indicate greater cumulative side effect burden. Participants contributed all available session ratings with no imputation. For reporting, participant level cumulative scores were averaged across participants for each symptom and summarized as mean and standard deviation. |
| Number of Participants Reporting Solicited Side Effects During RS tDCS Treatment | Assessed after each RS tDCS session during the 4 week treatment period | Predefined, expected side effects associated with RS tDCS were prospectively and systematically collected using a standardized post session side effect questionnaire administered after each RS tDCS session. Solicited side effects included itching, burning, headache, fatigue, nervousness, dizziness, difficulty concentrating, and other expected sensations related to stimulation. This outcome summarizes the number of participants who reported one or more solicited side effects at any time during the treatment period. These solicited side effect assessments were collected as part of structured safety monitoring and are reported as outcome measures rather than as adverse events. Unsolicited adverse events meeting ClinicalTrials.gov reporting criteria are reported separately in the Adverse Events module. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYeates Conwell, MD
University of Rochester
Participant flow
Pre-assignment details
Excluded (n=24) Not meeting inclusion criteria (n=11) Declined to participate (n=3) Refused questioning (n=1) Exclusion criteria (n=5) Unable to approach (n=4)
Participants by arm
| Arm | Count |
|---|---|
| Active Home-based Transcranial Direct Current Stimulation (tDCS) The active home-based tDCS delivers a constant current intensity of 2mA on the subject's scalp, with electrodes positioned bilaterally (anodal-left and cathodal-right), on the dorsolateral prefrontal cortex (DLPFC), for 30 minutes.
Home-based transcranial direct current stimulation (tDCS): Each participant will be asked to do ten home-based tDCS sessions, one per weekday, during two weeks (Monday to Friday). Each session will be supervised remotely by a member of the research staff via HIPAA-compliant videoconference. Participants will receive active home-based tDCS (constant current intensity of 2mA) anodal-left and cathodal-right prefrontal for 30 minutes per session daily for 2 weeks (Monday to Friday - 10 sessions overall) via a tDCS stimulator with headgear and 5x7 (35cm2) saline-soaked surface sponge electrodes. | 5 |
| Sham Home-based Transcranial Direct Current Stimulation (tDCS) The sham home-based tDCS looks identical to a typical active home-based tDCS cap but delivers a 30-second ramp-up (0-2 mA) stimulation followed by a 30-second ramp-down (2-0 mA) at the beginning and end of the application.
Sham home-based transcranial direct current stimulation (tDCS): Each participant will be asked to do ten home-based sessions, one per weekday, during two weeks (Monday to Friday). Each session will be supervised remotely by a member of the research staff via HIPAA-compliant videoconference. Participants will receive sham home-based tDCS for 30 minutes per session daily for 2 weeks (Monday to Friday - 10 sessions overall) via a tDCS stimulator with headgear and 5x7 (35cm2) saline-soaked surface sponge electrodes. | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Active Home-based Transcranial Direct Current Stimulation (tDCS) | Sham Home-based Transcranial Direct Current Stimulation (tDCS) | Total |
|---|---|---|---|
| Age, Continuous | 21.80 years STANDARD_DEVIATION 2.68 | 22.00 years STANDARD_DEVIATION 2.45 | 21.89 years STANDARD_DEVIATION 2.42 |
| History of suicidal ideation or behavior at hospital admission | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White/Non-Hispanic | 5 Participants | 2 Participants | 7 Participants |
| Sex/Gender, Customized Sex Female | 2 Participants | 3 Participants | 5 Participants |
| Sex/Gender, Customized Sex Male | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Sex Not sure (non-binary) | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Sex Transgender (Female-to-Male) | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Sex Transgender (Male-to-Female) | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 2 / 5 | 1 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions
Number of completed remotely supervised transcranial direct current stimulation (RS-tDCS) sessions, for both active and sham groups: We expect at least 70% of the subjects to complete at least 5 of recommended 10 RS-tDCS sessions.
Time frame: 14 days after start of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Home-based Transcranial Direct Current Stimulation (tDCS) | Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions | 4 Participants |
| Sham Home-based Transcranial Direct Current Stimulation (tDCS) | Feasibility of the Intervention: Number of Participants Who Completed 5 or More Remotely Supervised Transcranial Direct Current Stimulation (RS-tDCS) Sessions | 3 Participants |
Secondary
Acceptability of the Intervention
Acceptability based on subject's readiness, self-confidence, and satisfaction will be considered if at least 60% of all subject's rate strongly agree or agree on the acceptability questionnaire item 11: Overall, I felt that transcranial electrical stimulation treatment benefited me (the questionnaire is a 5-item Likert scale with the following response options Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree).
Time frame: This information will be collected after the final RS-tDCS session (that is, the tenth RS-tDCS session)
Secondary
Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS is a 10-item questionnaire that includes questions on the following symptoms: 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A higher MADRS score indicates more severe depression.
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Secondary
Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS is a 10-item questionnaire that includes questions on the following symptoms: 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A higher MADRS score indicates more severe depression.
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Secondary
Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS is a 10-item questionnaire that includes questions on the following symptoms: 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Each item yields a score of 0 to 6. The overall score ranges from 0 to 60. A higher MADRS score indicates more severe depression.
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Secondary
Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS)
The RRS encompasses 22 items. Each item is rated on a 4-point Likert scale: 1, almost never; 2, sometimes; 3, often; 4, almost always. The score on this scale is obtained by simply summing the scores on the 22 items.
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Secondary
Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS)
The RRS encompasses 22 items. Each item is rated on a 4-point Likert scale: 1, almost never; 2, sometimes; 3, often; 4, almost always. The score on this scale is obtained by simply summing the scores on the 22 items.
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Secondary
Intensity of Rumination as Assessed by the Ruminative Responses Scale (RRS)
The RRS encompasses 22 items. Each item is rated on a 4-point Likert scale: 1, almost never; 2, sometimes; 3, often; 4, almost always. The score on this scale is obtained by simply summing the scores on the 22 items.
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Secondary
Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25), with higher scores indicating more severe suicidal ideation.
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Secondary
Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25), with higher scores indicating more severe suicidal ideation.
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Secondary
Intensity of Suicidal Ideation as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25), with higher scores indicating more severe suicidal ideation.
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Secondary
Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS
Proportion of patients who answered no for both questions 1 (Have you wished you were dead or wished you could go to sleep and not wake up?) and 2 (Have you actually had any thoughts of killing yourself?) of the C-SSRS
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Secondary
Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS
Proportion of patients who answered no for both questions 1 (Have you wished you were dead or wished you could go to sleep and not wake up?) and 2 (Have you actually had any thoughts of killing yourself?) of the C-SSRS
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Secondary
Proportion of Patients With no Suicidal Ideation as Assessed by the C-SSRS
Proportion of patients who answered no for both questions 1 (Have you wished you were dead or wished you could go to sleep and not wake up?) and 2 (Have you actually had any thoughts of killing yourself?) of the C-SSRS
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Secondary
Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale
The 16 items of the CAST Scale assess symptoms across five domains: anxiety (three items, subscore range 3-15), irritability (five items, subscore range 5-25), mania (four items, subscore range 4-20), insomnia (two items, subscore range 2-10), and panic (two items, subscore range 2-10). The total CAST score ranges from 16 to 80. Each item is rated on a 5-point Likert scale: 1, strongly disagree; 2, disagree; 3, neither agree nor disagree; 4, agree; or 5, strongly agree, with higher scores indicating more severe symptoms.
Time frame: day 14 [+ 7 days] from the first RS-tDCS session
Secondary
Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale
The 16 items of the CAST Scale assess symptoms across five domains: anxiety (three items, subscore range 3-15), irritability (five items, subscore range 5-25), mania (four items, subscore range 4-20), insomnia (two items, subscore range 2-10), and panic (two items, subscore range 2-10). The total CAST score ranges from 16 to 80. Each item is rated on a 5-point Likert scale: 1, strongly disagree; 2, disagree; 3, neither agree nor disagree; 4, agree; or 5, strongly agree, with higher scores indicating more severe symptoms.
Time frame: day 30 [+ 7 days] from the first RS-tDCS session
Secondary
Symptoms Associated With Suicidal Ideation as Assessed by the Concise Associated Symptoms Tracking (CAST) Scale
The 16 items of the CAST Scale assess symptoms across five domains: anxiety (three items, subscore range 3-15), irritability (five items, subscore range 5-25), mania (four items, subscore range 4-20), insomnia (two items, subscore range 2-10), and panic (two items, subscore range 2-10). The total CAST score ranges from 16 to 80. Each item is rated on a 5-point Likert scale: 1, strongly disagree; 2, disagree; 3, neither agree nor disagree; 4, agree; or 5, strongly agree, with higher scores indicating more severe symptoms.
Time frame: day 60 [+ 10 days] from the first RS-tDCS session
Secondary
The Level of Side Effects
The level of side effects will be assessed at the end of each RS-tDCS session on a 0 (not at all) to 10 (highest degree) scale, which includes the following symptoms: 1. Itching; 2. Burning; 3. Headache; 4. Fatigue; 5. Nervousness; 6. Dizziness; 7. Difficulty concentrating. The total score is the sum of the 7 items, varying from 0 to 70. Higher scores indicate higher levels of side effects.
Time frame: The level of side effects will be assessed at the end of each RS-tDCS session
Secondary
Treatment Emergent Event
After each RS-tDCS session and clinical assessment, subjects will be asked Have you had any new symptoms, new medical conditions or been started on new medication/treatment since we last saw you?. This information will help research staff to judge about potential adverse events related to the trial. In addition, changes in treatment will help researchers to account for them in data analysis and the study's results interpretation.
Time frame: The level of side effects will be assessed at the end of each RS-tDCS session and at days 14 [+ 7 days], 30 [+ 7 days], and 60 [+ 10 days] from the first RS-tDCS session