Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation
Study Details
Study Description
Brief Summary
The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Active Stimulation MxN-9 HD-tES Stimulator (Soterix Inc.) will be used to deliver direct current (High-Definition Transcranial Direct Current Stimulation) to the target brain areas via electrodes and conducive gels. A constant current will be applied for 20 minutes with peak current of 2 mA. The 9 electrodes (8 channels + 1 ground) positions and current intensity have been determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left VLPFC (x=-50, y=+26, z=+8) and the PCC (x=1, y=-61, z=38) with inward field orientation. |
Device: MxN-9 HD-tES Stimulator (Soterix Inc.)
Patients will be stimulated with high definition transcranial direct current stimulation (HD-tDCS) for 5 weeks (every weekdays; one session per day). In each session, a constant current at 2mA will be passed on the target brain areas for 20 minutes.
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Sham Comparator: Inactive Stimulation The current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down, and thus no active stimulation will be administered except for the initial and last 1 minutes of 20 minute stimulation duration. |
Device: Sham Stimulation
The same stimulation protocol will be used as in Active stimulation except that a sham mode will be selected in the stimulator machine.
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Outcome Measures
Primary Outcome Measures
- Functional Connectivity [Change from Baseline Functional Connectivity after 5 month HD-tDCS/CBTm treatment]
Functional Connectivity between the targeted brain regions measured by resting state fMRI (level of synchronous fMRI signal, standardized)
Eligibility Criteria
Criteria
Inclusion Criteria:
- all patients who have agreed to participate in virtual mental health treatment at health care sites throughout Manitoba. Eligible participants will be those enrolled in a range of mental health programs, including CBT, DBT, virtual hospital wards, and group-based treatment (e.g., CBTm, Managing Difficult Emotions, etc). The target population will also include providers and decision makers offering virtual mental health programs. Individuals must meet the following criteria to be eligible to participate in the study: 1) must be a patient/client enrolled in a virtual mental health program OR a provider/decision maker offering a virtual mental health program, and 2) located within Manitoba
Exclusion Criteria:
- contraindication for MRI (e.g., metallic implants and claustrophobia)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Manitoba | Winnipeg | Manitoba | Canada | R3E 0J9 |
Sponsors and Collaborators
- University of Manitoba
- Winnipeg Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS25578