NCT03178903

Brief Summary

The purpose of this study is to examine the efficacy of tDCS (transcranial direct current stimulation) for increasing exercise adherence among low active individuals with elevated depressive symptoms. The investigators expect that this project will contribute much needed knowledge about the role that tDCS can play in changing the affective experience of exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 7, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

February 27, 2023

Completed
Last Updated

February 27, 2023

Status Verified

January 1, 2023

Enrollment Period

2.9 years

First QC Date

May 10, 2017

Results QC Date

January 3, 2023

Last Update Submit

January 31, 2023

Conditions

DepressionPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Levels

    Accelerometry-based moderate-to-vigorous physical activity (MVPA)

    8 week assessment

Study Arms (2)

tDCS and Aerobic Exercise

ACTIVE COMPARATOR

Each participant will undergo a 20-minute session of transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.

Other: tDCSBehavioral: Aerobic Exercise (AE)

Sham tDCS and Aerobic Exercise

SHAM COMPARATOR

Each participant will undergo a 20-minute session of sham transcranial direct current stimulation (tDCS) delivered to the dorsolateral prefrontal cortex (DLPFC). Each session of tDCS will be immediately followed by a supervised 30-minute, moderate-intensity bout of exercise. These procedures will occur 3x/week for 8 weeks.

Other: Sham tDCSBehavioral: Aerobic Exercise (AE)

Interventions

tDCSOTHER

Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.

tDCS and Aerobic Exercise
Sham tDCSOTHER

Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.

Sham tDCS and Aerobic Exercise
Aerobic Exercise (AE)BEHAVIORAL

Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.

Sham tDCS and Aerobic ExercisetDCS and Aerobic Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be between 18 and 65 years of age
  • be low active
  • have elevated levels of depressive symptoms
  • interested in starting an exercise program in the next month

You may not qualify if:

  • history of mania or hypomania
  • current psychotic disorder
  • current DSM-5 diagnosis of an eating disorder
  • DSM-5 moderate and severe substance use disorder
  • current suicidality or homicidality
  • current DSM-5 diagnosis of major depressive disorder that is not currently being treated with pharmacotherapy or psychotherapy
  • physical disabilities or medical problems that would prevent participation in moderate intensity exercise or may be contraindicated for tDCS
  • current pregnancy or intent to become pregnant during the next 8 weeks
  • pacemaker or metal implanted in the cranial cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Transcranial Direct Current StimulationExercise

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Ana M. Abrantes, Ph.D.
Organization
Butler Hospital
Ana_Abrantes@Brown.edu
4014556440

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2017

First Posted

June 7, 2017

Study Start

February 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 27, 2023

Results First Posted

February 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)