Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HD-tDCS to Modulate Connectivity

NCT05959551

Electricity; Effects

RECRUITING NA

Psychotherapy Plus: Combining Cognitive Behavioral Therapy With tDCS

NCT02633449

Major Depression

COMPLETED NA

Mindful Breathing and tDCS for Depression

NCT03897699

Depression Depressive Disorder

COMPLETED NA

MRI-Guided High-Definition Transcranial Direct Current Stimulation (tDCS) for Depression

NCT05090397

Depression

COMPLETED NA

Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

NCT06399731

Parkinson Disease Mild Cognitive Impairment

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Anxiety Stress Disorders, Post-Traumatic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Thirty participants among those who are enrolled in the parent clinical trial will be recruited. Participants will receive 5-week CBTm treatment and a battery of psychological assessment as part of the parent clinical trial. Individuals enrolled in the current study will receive daily HD-tDCS during the period of CBTm treatment (5-week). Half of the individuals will receive real stimulation and the other half will receive sham stimulation. Participants will be scanned with MRI before and after the 5-week treatment. EEG data will be collected before (10 minutes), during (20 minutes) and after (20 minutes) each HD-tDCS session .

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Sham stimulation mode will be used in the HD-tES machine. For sham 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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

MxN-9 HD-tES Stimulator (Soterix Inc.)

Intervention Type DEVICE

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.

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.

Group Type SHAM_COMPARATOR

Sham Stimulation

Intervention Type DEVICE

The same stimulation protocol will be used as in Active stimulation except that a sham mode will be selected in the stimulator machine.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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