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This is an open label pilot feasibility study that will recruit 15 participants. The purpose of the pilot study will be to evaluate the feasibility of open label Transcranial direct current stimulation (tDCS) in combination with computerized cognitive behavior therapy (cCBT) to maintain wellness following an acute course of Electroconvulsive therapy (ECT) for up to 6 months.
Home-based tDCS-cCBT will involve 30-min tDCS (3 days per week) for the first 3 months and once weekly for the subsequent 3 months, in combination with computerized CBT delivered through an online portal for the duration of tDCS each day. Subjects who miss 4 consecutive treatment days or 20 percent of total treatments will be excluded from the study as it is our intention to encourage compliance with the proposed treatments to maintain optimal wellness. All missed treatment days will be recorded in a log for each participant.
Aim 1. To investigate the effectiveness of maintenance tDCS-cCBT for patients with MDD who have responded to a successful acute course of ECT.
Hypothesis 1. tDCS-cCBT will effectively maintain treatment response in MDD in a manner that is non-inferior to that of maintenance ECT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS + cCBT | Other | After baseline assessments are complete, participants will be provided with a tDCS device (Soterix Medical tDCS mini-Clinical Trials system (mini-CT)), which is deactivated until a code is provided by the research staff. Each tDCS session will be delivered in combination with a computerized CBT module and participants will progress through the computerized CBT course (Beacon Therapist-Assisted-Internet-Delivered CBT) over the 6 months of treatment at their own pace. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soterix Medical tDCS mini-Clinical Trials system (mini-CT) | Device | Participants are provided with an activation code. This code will unlock a single session with the pre-set 30 minute duration and intensity (direct current 2mA, current density 0.80A/m2, with anode over the left and cathode over the right dorsolateral prefrontal cortex, respectively). Home-based tDCS will involve 30-min tDCS (3 days per week) for the first 3 months and once weekly for the subsequent 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Maintained remission of depressive symptoms as measured by the Hamilton Rating Scale for Depression - 24 | Hamilton Rating Scale for Depression (24-item version)
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zafiris J Daskalakis, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M6J 1H4 | Canada |
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| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Computerized CBT (cCBT) | Behavioral | Each tDCS session will be delivered in combination with a computerized CBT module and participants will progress through the computerized CBT course (Beacon Therapist-Assisted-Internet-Delivered CBT) over the 6 months of treatment at their own pace. |
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