Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Feasibility of the intervention |
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. |
14 days after start of treatment |
|
| 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. |
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. |
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. |
day 60 [+ 10 days] from the first RS-tDCS session |
|
| 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"). |
This information will be collected after the final RS-tDCS session (that is, the tenth 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 |
day 14 [+ 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 |
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 |
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. |
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. |
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. |
day 60 [+ 10 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. |
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. |
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. |
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. |
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. |
day 30 [+ 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. |
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. |
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. |
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 |
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