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

NCT03680664 | Completed

• 1 other identifier: 065/2017
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mild Cognitive Impairment; Dementia; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Change in cognitive and memory function

  Cognitive and memory function measured by a neuropsychological battery examining memory, executive functioning and attention

  Baseline, Approximately 10-14 weeks after baseline

Secondary Outcomes (4)

• Change in depressive symptoms

  Baseline, Approximately 10-14 weeks after baseline

• Change in anxiety symptoms

  Baseline, Approximately 10-14 weeks after baseline

• Change in quality of life

  Baseline, Approximately 10-14 weeks after baseline

• Change in mindfulness

  Baseline, Approximately 10-14 weeks after baseline

Study Arms (2)

Active tDCS + MBSR

EXPERIMENTAL

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 milliamps (mA) (current density = 0.57 A/m2) for 30 min per day. 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 Compact Discs-Read Only Memory (CD-ROMs) of meditative practice.

Device: Active tDCS; Behavioral: MBSR

sham tDCS + MBSR

SHAM COMPARATOR

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. 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.

Other: sham tDCS; Behavioral: MBSR

Interventions

Active tDCS DEVICE

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.

Also known as: Transcranial Direct Current Stimulation

Active tDCS + MBSR

sham tDCS OTHER

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.

sham tDCS + MBSR

MBSR BEHAVIORAL

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.

Also known as: Mindfulness-Based Stress Reduction

Active tDCS + MBSR; sham tDCS + MBSR

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling men and women aged 60 or above.
• Current cognitive complaints per participant self-report, but with intact cognitive function as defined by a score of 0-9 on the Short Blessed Test (SBT) and a Montreal Cognitive Assessment (MoCA) score ≥25 per PI discretion.
• PROMIS depression scale score of greater or equal to 16 and/or PROMIS anxiety score greater or equal to 14.
• Ability to read and speak English fluently enough to complete all research assessments.
• Corrected visual ability to read newspaper headlines.
• Hearing capacity to respond to a raised conversational voice.
• Willingness and ability to provide informed consent.

You may not qualify if:

• Diagnostic and Statistical Manual IV (DSM-IV) criteria for current or life-time bipolar disorder, schizophrenia, schizoaffective disorder or any other psychotic disorders.
• Untreated post-traumatic stress disorder.
• A MoCA score \<25 or a score greater than 9 on the SBT, per PI discretion
• Use of cognitive enhancers such as anticholinergic medications within the past 6weeks.
• DSM-IV criteria for any substance dependence within the past 6 months that would affect their participation, per PI discretion.
• Unstable medical illness (e.g. uncontrolled diabetes mellitus or hypertension).
• Concurrent cognitive training, such as brain-training software, participation in psychotherapy or regular engagement in mindfulness practice and/or yoga.
• Taking anticonvulsant or antipsychotics that cannot be safely tapered and discontinued.
• Significant neurological condition (e.g. stroke, seizure disorder, multiple sclerosis).
• A pace-maker or other metal implants that would preclude safe use of tDCS.
• Intelligence Quotient (IQ) \< 70 as estimated by the Wechsler Test of Adult Reading.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University of Toronto: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (1)

• Brooks H, Oughli HA, Kamel L, Subramanian S, Morgan G, Blumberger DM, Kloeckner J, Kumar S, Mulsant BH, Lenze EJ, Rajji TK. Enhancing Cognition in Older Persons with Depression or Anxiety with a Combination of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS): Results of a Pilot Randomized Clinical Trial. Mindfulness (N Y). 2021;12(12):3047-3059. doi: 10.1007/s12671-021-01764-9. Epub 2021 Oct 5.

  PMID: 34630733 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Mood Disorders; Cognitive Dysfunction; Dementia

Interventions

Transcranial Direct Current Stimulation; Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy

Study Officials

• Tarek Rajji

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 21, 2018
• Study Start: November 8, 2018
• Primary Completion: July 4, 2019
• Study Completion: July 4, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01

Locations

CA (1)