tDCS for Increasing Exercise Adherence in Depressed Individuals

Depression Clinical Trial

— StRIDE  

Official title:

tDCS for Increasing Exercise Adherence in Individuals With Elevated Depressive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178903
• Other study ID #: 1608-002
• Secondary ID: R21CA214102
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2023
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Physical Activity

Intervention

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.
• 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.

Behavioral:
• Aerobic Exercise (AE)
Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Levels	Accelerometry-based moderate-to-vigorous physical activity (MVPA)	8 week assessment