Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators propose a study of telehealth supervised, caregiver-delivered, home-based transcranial direct current stimulation (tDCS) for antidepressant treatment of patients with an acute depressive episode.
This is an open-label pilot feasibility telemedicine study. This pilot will involve a total of 37 stimulations sessions / at home visits (30- minute sessions of multichannel excitatory tDCS targeting the left DPFC) and the maintenance of a daily treatment diary to be completed by the subjects immediately after enrollment and 12 weeks following the last study visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS MDD | Experimental | A group of 5 participants with major depressive disorder (MDD). tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions. Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item clinical rating scale to measure the severity of depressive symptoms based on a clinical interview with a participant/patient. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60, and includes questions related to: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Cut off points are: 0 to 6 - normal, symptom absent, 7 to 19 - mild depression, 20 to 34 - moderate depression, >34 - severe depression. Clinical remission is considered as a MADRS score ≤ 10. The primary outcome will be total MADRS score from baseline to one-month follow-up (pre and post-intervention; 12 weeks). | 12 weeks |
| Number of Treatment-Emergent Adverse Events [Safety and Tolerability] and Missed Sessions | Feasibility and tolerability/safety will be evaluated using home-based data as recorded in the Neuroelectrics portal: number of missed sessions and number of adverse events reported on adverse event questionnaire | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item questionnaire that captures life satisfaction over the past week across several domains. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. (Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score). This measure was administered at baseline and at 1 month follow-up, which were separated by 12 weeks. |
Not provided
Patients meeting one of the following criteria may be eligible to participate in this study.
The benefits of this project address a present need due to the COVID-19 pandemic, but also go beyond the present situation and address a larger, pre-existing need. Across all these potential groups of participants, prospective participants will:
Inclusion Criteria:
Individuals with MDD
Participants will be men and women who:
Are aged 50 or older
Able to read, write, and communicate in English
Have a caregiver who is willing and able to provide the home tDCS sessions.
Participants must be under the care of a treating psychiatrist who approves of the study participation and believes that TMS or ECT is indicated for his/her patient but that
Participants with MDD must fit into one of the following 3 groups (medication-resistant MDD defined as 1) participant's condition has not responded to prescribed antidepressant medication; 2) participant is medication intolerant, or 3) some other underlying reason):
Further, participants must:
Further, participants must have a willing and eligible caregiver-administrators who is:
Exclusion Criteria:
Exclusion criteria for participants with MDD will be:
Understanding will be assessed by asking the participant with MDD to answer the following three questions:
Exclusion criteria for Participant caregiver-administrators:
Understanding will be assessed by asking the participant caregiver-administrator to answer the following three questions:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alvaro Pascual-Leone, Dr. | Hinda and Arthur Marcus Institute for Aging Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hinda and Arthur Marcus Institute for Aging Research | Boston | Massachusetts | 02131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31005790 | Result | Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019 Jun 1;252:475-483. doi: 10.1016/j.jad.2019.04.041. Epub 2019 Apr 10. | |
| 28709880 | Result | Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No significant events occurred between participant enrollment and start of the intervention.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | tDCS MDD | A group of participants with major depressive disorder (MDD). tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic. tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions. Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 - Acute Stimulation, Daily tDCS |
|
| ||||||||||||||||||
| Phase 2 - Tapered Stimulation Schedule |
| |||||||||||||||||||
| Phase 3 - Follow up Phase |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | tDCS MDD | A group of 5 participants with major depressive disorder (MDD). tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic. tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions. Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
|
| 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 | Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item clinical rating scale to measure the severity of depressive symptoms based on a clinical interview with a participant/patient. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60, and includes questions related to: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Cut off points are: 0 to 6 - normal, symptom absent, 7 to 19 - mild depression, 20 to 34 - moderate depression, >34 - severe depression. Clinical remission is considered as a MADRS score ≤ 10. The primary outcome will be total MADRS score from baseline to one-month follow-up (pre and post-intervention; 12 weeks). | A group of participants with major depressive disorder (MDD). | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
6 months
It does not differ.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tDCS MDD | A group of participants with major depressive disorder (MDD). tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic. tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions. Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pascual-Leone | Hebrew SeniorLife | 6179715372 | apleone@hsl.harvard.edu |
Not provided
| 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 | Jan 13, 2021 | Dec 8, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 12 weeks |
| The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) | The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) is a self-report measure of depressed symptomology. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16). Severity of depression can be judged based on the total score, which ranges from 0 to 27. 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression This measure was administered at baseline and at 1 month follow-up, which were separated by 12 weeks. | 12 weeks |
| Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is 21-item multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. For each item, a value of 0 to 3 is assigned and then the total score is summed. The standard cut-offs are as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. This scale was given at baseline and 12 weeks later at the 1-month follow-up visit. | 12 weeks |
| Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (HDRS) is comprised of 21 items for inquiry, and only the first 17 are used in scoring. Each question examines a different symptom or aspect of depression, including: mood, guilt, suicidal ideation, insomnia, agitation, and somatic symptoms. Items are scaled either from 0 - 2 or 0 - 4, and each item is summed for a total score. Benchmarks suggested at: 0-7 normal; 8 - 13 mild depression; 14-18 moderate depression; 19-22 severe depression ; >=23 very severe depression. This scale was administered at baseline and 12 weeks later at the 1-month follow-up visit. | 12 weeks |
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. This assessment was administered at baseline and at 1 month post-intervention (12 week span). | 12 weeks |
| Digit Span Forward | A digit-span forward task measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in the order that it was presented to the participant. The number of digits on the first trial is three. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done. | 12 weeks |
| Digit Span Backward | A digit-span task backwards measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in backwards order. The number of digits on the first trial is two. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done. | 12 weeks |
| 27056623 | Result | Brunoni AR, Moffa AH, Fregni F, Palm U, Padberg F, Blumberger DM, Daskalakis ZJ, Bennabi D, Haffen E, Alonzo A, Loo CK. Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. Br J Psychiatry. 2016 Jun;208(6):522-31. doi: 10.1192/bjp.bp.115.164715. Epub 2016 Apr 7. |
| 35185515 | Derived | Cappon D, den Boer T, Jordan C, Yu W, Lo A, LaGanke N, Biagi MC, Skorupinski P, Ruffini G, Morales O, Metzger E, Manor B, Pascual-Leone A. Safety and Feasibility of Tele-Supervised Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder. Front Aging Neurosci. 2022 Feb 2;13:765370. doi: 10.3389/fnagi.2021.765370. eCollection 2021. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a clinician-rated scale which consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology (Montgomery & Åsberg, 1979). The primary outcome was the change in the MADRS score from baseline to the 1-month follow-up (12 week span). Remission was defined as MADRS score ≤ 10. | Mean | Full Range | units on a scale |
|
| Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item questionnaire that captures life satisfaction over the past week across several domains. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. | Mean | Full Range | units on a scale |
|
| Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) | The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) is a self-report measure of depressed symptomology. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance, Sad mood,The total score ranges from 0 to 27. 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression | Mean | Full Range | units on a scale |
|
| Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is 21-item multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. For each item, a value of 0 to 3 is assigned and then the total score is summed. The standard cut-offs are as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. | Mean | Full Range | units on a scale |
|
| Hamilton Depression Rating Scale (HDRS) | Hamilton Depression Rating Scale (HDRS) is comprised of 21 items for inquiry, and only the first 17 are used in scoring. Each question examines a different symptom or aspect of depression, including: mood, guilt, suicidal ideation, insomnia, agitation, and somatic symptoms. Items are scaled either from 0 - 2 or 0 - 4, and each item is summed for a total score. Benchmarks suggested at: 0-7 normal; 8 - 13 mild depression; 14-18 moderate depression; 19-22 severe depression ; >=23 very severe depression. This scale was administered at baseline and 12 weeks later at the 1-month follow-up visit. | Mean | Full Range | units on a scale |
|
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. This assessment was administered at baseline and at 1 month post-intervention (12 week span). | Mean | Full Range | units on a scale |
|
| Digit Span Forward | A digit-span forward task measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in the order that it was presented to the participant. The number of digits on the first trial is three. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done. | Mean | Full Range | Count of numbers correctly recalled |
|
| Digit Span Backward | A digit-span task backwards measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in backwards order. The number of digits on the first trial is two. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done. | Mean | Full Range | Count of numbers correctly recalled |
|
| tDCS MDD |
A group of participants with major depressive disorder (MDD). tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic. tDCS: Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions. Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
|
|
|
| Primary | Number of Treatment-Emergent Adverse Events [Safety and Tolerability] and Missed Sessions | Feasibility and tolerability/safety will be evaluated using home-based data as recorded in the Neuroelectrics portal: number of missed sessions and number of adverse events reported on adverse event questionnaire | A group of participants with major depressive disorder (MDD). | Posted | Number | number of sessions/events | 12 weeks |
|
|
|
| Secondary | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item questionnaire that captures life satisfaction over the past week across several domains. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. (Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score). This measure was administered at baseline and at 1 month follow-up, which were separated by 12 weeks. | A group of participants with Major Depressive Disorder (MDD). | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| Secondary | The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) | The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) is a self-report measure of depressed symptomology. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16). Severity of depression can be judged based on the total score, which ranges from 0 to 27. 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression This measure was administered at baseline and at 1 month follow-up, which were separated by 12 weeks. | A group of participants with major depressive disorder (MDD). | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| Secondary | Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is 21-item multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. For each item, a value of 0 to 3 is assigned and then the total score is summed. The standard cut-offs are as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. This scale was given at baseline and 12 weeks later at the 1-month follow-up visit. | A group of participants with major depressive disorder (MDD). | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| Secondary | Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (HDRS) is comprised of 21 items for inquiry, and only the first 17 are used in scoring. Each question examines a different symptom or aspect of depression, including: mood, guilt, suicidal ideation, insomnia, agitation, and somatic symptoms. Items are scaled either from 0 - 2 or 0 - 4, and each item is summed for a total score. Benchmarks suggested at: 0-7 normal; 8 - 13 mild depression; 14-18 moderate depression; 19-22 severe depression ; >=23 very severe depression. This scale was administered at baseline and 12 weeks later at the 1-month follow-up visit. | A group of participants with major depressive disorder (MDD). | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| Secondary | Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. This assessment was administered at baseline and at 1 month post-intervention (12 week span). | A group of participants with major depressive disorder (MDD). | Posted | Mean | Full Range | units on a scale | 12 weeks |
|
|
|
| Secondary | Digit Span Forward | A digit-span forward task measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in the order that it was presented to the participant. The number of digits on the first trial is three. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done. | A group of participants with major depressive disorder (MDD). | Posted | Mean | Full Range | Count of numbers correctly recalled | 12 weeks |
|
|
|
| Secondary | Digit Span Backward | A digit-span task backwards measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in backwards order. The number of digits on the first trial is two. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done. | A group of participants with major depressive disorder (MDD). | Posted | Mean | Full Range | Count of numbers correctly recalled | 12 weeks |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
Not provided
Not provided
Not provided
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |