tDCS for Increasing Exercise Adherence in Depressed Individuals (StRIDE)

tDCS for Increasing Exercise Adherence in Individuals With Elevated Depressive Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Depression; Physical Activity
• Intervention / Treatment: Other: tDCS; Behavioral: Aerobic Exercise (AE); Other: Sham tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tDCS and Aerobic Exercise; 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: tDCS; 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.; Behavioral: Aerobic Exercise (AE); Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
Sham Comparator: Sham tDCS and Aerobic Exercise; 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.	Behavioral: Aerobic Exercise (AE); Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.; Other: Sham tDCS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Levels	Accelerometry-based moderate-to-vigorous physical activity (MVPA)	8 week assessment

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 7, 2017

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 1608-002; R21CA214102 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No