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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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This is a double-blind, multi-site, randomized controlled trial (RCT) that will recruit 200 participants.The purpose of the RCT will be to evaluate the efficacy of transcranial direct current stimulation (tDCS) in combination with mindfulness meditation compared to sham tDCS to maintain wellness following an acute course of repetitive transcranial magnetic stimulation (rTMS) for up to 6 months.
Home-based tDCS (active vs. sham) 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 mindfulness mediation for the duration of tDCS each treatment. Subjects who miss 4 consecutive treatment days or 20 percent of total treatments will be exit the treatment intervention as it is our intention to encourage compliance with the proposed treatments to maintain optimal wellness.
Aim 1. To investigate the efficacy of at home maintenance tDCS for patients with MDD who have responded to a successful acute course of rTMS.
Hypothesis 1. Patients receiving tDCS will have a higher proportion of sustained responders or remitters after 6 months compared to sham tDCS.
Exploratory Aim 2. To investigate clinical predictors of sustained response to rTMS using tDCS Hypothesis 2. Remitters and those not on benzodiazepines will be associated with greater likelihood of sustained response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active tDCS + mindfulness meditation | Experimental | Participants randomized to this group will receive active tDCS 3 times a week for approximately 3 months and then weekly for 3 months. After completing baseline procedures they will be trained how to apply the tDCS device themselves. The first 3-6 treatments will be completed at the hospital to ensure proper and safe application. Prior to taking the tDCS device home, they will pass the self-application scale adequately 3 times. Each treatment session lasts 30 minutes, during which, they will engage in mindfulness meditation. |
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| sham tDCS + mindfulness meditation | Sham Comparator | Participants randomized to this group will receive sham tDCS 3 times a week for approximately 3 months and then weekly for 3 months. After completing baseline procedures they will be trained how to apply the tDCS device themselves. The first 3-6 treatments will be completed at the hospital to ensure proper and safe application. Prior to taking the tDCS device home, they will pass the self-application scale adequately 3 times. Each treatment session lasts 30 minutes, during which, they will engage in mindfulness meditation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active tDCS + mindfulness meditation | 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). These devices will be set to active. Each tDCS sessions will be delivered in combination with a guided mindfulness meditation that we have recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients maintaining remission of depressive symptoms or response to rTMS treatments as measured by the Hamilton Rating Scale for Depression - 17 Hamilton Rating Scale for Depression (17-item version) |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders and remitters who relapse | Relapse defined separately for responders and remitters Responders who experience >50% worsening of their HRSD-17 scores from baseline, over 2 consecutive assessments, will discontinue tDCS and discuss treatment options with a study physician. Remitters will discontinue tDCS and discuss treatment options if they have an HRSD-17 score of >18 over 2 consecutive assessments separated by at least 1 week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Blumberger, MD, MSc | 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 | ||
| Toronto Western Hospital |
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| Label | URL |
|---|---|
| Description 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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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| sham tDCS + mindfulness meditation | Other | 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). These devices will be set to sham. Each tDCS sessions will be delivered in combination with a guided mindfulness meditation that we have recorded. |
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| 6 months |
| Toronto |
| Ontario |
| Canada |