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tDCS for Increasing Exercise Adherence in Depressed Individuals (StRIDE)

Primary Purpose

Depression, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sham tDCS
Aerobic Exercise (AE)
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

tDCS and Aerobic Exercise

Sham tDCS and Aerobic Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Physical Activity Levels
Accelerometry-based moderate-to-vigorous physical activity (MVPA)

Secondary Outcome Measures

Full Information

First Posted
May 10, 2017
Last Updated
January 31, 2023
Sponsor
Butler Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03178903
Brief Title
tDCS for Increasing Exercise Adherence in Depressed Individuals
Acronym
StRIDE
Official Title
tDCS for Increasing Exercise Adherence in Individuals With Elevated Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Exercise adherence is a significant public health problem. Affective experiences during exercise predict long-term physical activity (PA) levels. Therefore, approaches to improving the affective experience of exercise are both important and likely to have high impact. This may be particularly true among individuals with elevated depressive symptoms due to their tendency toward more negative and less positive affect. tDCS is a noninvasive brain stimulation approach with a growing body of literature supporting its effects on cognitive and emotional processing in varied populations, including some support for those with depression. In addition, there is recent increased interest in utilizing tDCS in the context of exercise (see above) and in obesity prevention. While the effects of tDCS on behavioral and cognitive functioning are still developing, promising findings have emerged for tDCS used in repeated combination with a behavioral or cognitive intervention. Given that tDCS is relatively safe, inexpensive, and portable, individuals who struggle with enjoying exercise could be afforded a practical option for increasing and maintaining physical activity levels. We propose to conduct a pilot randomized controlled trial of tDCS versus sham delivered 3x/week for 8 weeks in the context of a supervised aerobic exercise (AE) program among 72 low-active individuals with elevated depressive symptoms. Follow-up assessments will be conducted at end of treatment, 3, and 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS and Aerobic Exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham tDCS and Aerobic Exercise
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise (AE)
Intervention Description
Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
Primary Outcome Measure Information:
Title
Physical Activity Levels
Description
Accelerometry-based moderate-to-vigorous physical activity (MVPA)
Time Frame
8 week assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

tDCS for Increasing Exercise Adherence in Depressed Individuals

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