Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS)

NCT03680664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-01-06

No results posted yet for this study

Summary

Ideal interventions for the older aged population would be those that are easily accessible and associated with minimal burden on family members, the healthcare system and the individuals themselves. Mindfulness-Based Stress Reduction (MBSR) therapy and Transcranial Direct Current Stimulation (tDCS) are two interventions that may be effective in targeting cognitive deficits in individuals with anxiety, depression, and/or cognitive complaints. MBSR has been shown to decrease symptoms of depression and improve cognition and tDCS has been shown to improve cognition in the older aged population. The effectiveness of these two interventions combined to elicit changes in cognition has yet to be demonstrated. Therefore, the overall aim of the current research is to evaluate the efficacy of a combination of MBSR and tDCS to improve cognitive function in individuals with cognitive complaints and symptoms of anxiety and/or depression.

This will be a randomized pilot study. Sixteen individuals (separated into 2 groups of 8) will be randomized to receive a combination MBSR + active tDCS or MBSR + sham tDCS over 8 weeks. Participants will visit the Centre for Addiction and Mental Health (CAMH) once per week for in-class group sessions and will complete the intervention daily at home for the duration of the study. Participants will be aged 60 and older with cognitive complaints, with symptoms of anxiety and/or depression. Participants will be trained to self-administer tDCS and given guidelines for the completion of daily MBSR activities at home. It is hypothesized that the combination of active tDCS + MBSR will enhance cognition compared to the combination of sham tDCS + MBSR.

Conditions

  • Anxiety Disorders
  • Mood Disorders
  • Transcranial Direct Current Stimulation
  • tDCS
  • Stress Reduction

Interventions

DEVICE

Active tDCS

Excitatory bilateral stimulation to the frontal lobes, in particular the left and right DLPFC, will be applied. The anode will be placed at Fz and the cathode at Iz to achieve this bilateral frontal excitatory stimulation. Rubber electrodes will be inserted in 35-cm2 saline-soaked sponges and fixed with a headband. The direct current will be of 2 mA (current density = 0.57 A/m2) for 30 min per day.

OTHER

sham tDCS

The same tDCS parameters as as the active condition will be used; however, the device will be turned off after 1 minute of active stimulation.

BEHAVIORAL

MBSR

After a brief orientation session, the MBSR sessions will be conducted in 8 weekly 2.5 hour classes plus a half-day retreat. Content includes instruction and guidance to mindfulness meditation practices, gentle mindful movement, and various exercises to enhance mindfulness in everyday life. Participants will get daily at-home assignments with CDs of meditative practice.

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER
  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Tarek Rajji · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2019-07-04
Completion
2019-07-04

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03680664 on ClinicalTrials.gov