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Completed

NCT Number: NCT03178903

tDCS for Increasing Exercise Adherence in Depressed Individuals

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Other

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.

Sham tDCS

Other

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.

Aerobic Exercise (AE)

Behavioral

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

Primary outcomes

  1. Physical Activity Levels

    Time frame: 8 week assessment

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

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

tDCS for Increasing Exercise Adherence in Individuals With Elevated Depressive Symptoms

Acronym: StRIDE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2017
Registry last updated
Feb 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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