tDCS for Increasing Exercise Adherence in Depressed Individuals

NCT ID: NCT03178903

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-12-31

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.

Conditions

Depression; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: 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.

Aerobic Exercise (AE)

Intervention Type: BEHAVIORAL

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

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.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: 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)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Aerobic Exercise (AE)

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

R21CA214102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1608-002

Identifier Type: -

Identifier Source: org_study_id