Depression, Physical Activity
Conditions
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.
Interventions
OTHERtDCS
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.
OTHERSham 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.
BEHAVIORALAerobic Exercise (AE)
Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
Sponsors
National Cancer Institute (NCI)
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Levels | 8 week assessment | Accelerometry-based moderate-to-vigorous physical activity (MVPA) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. | 25 |
| 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.
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.
Aerobic Exercise (AE): Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks. | 26 |
| Total | 51 |
Baseline characteristics
| Characteristic | tDCS and Aerobic Exercise | Sham tDCS and Aerobic Exercise | Total |
|---|---|---|---|
| Age, Continuous | 48.9 years STANDARD_DEVIATION 9.7 | 50.1 years STANDARD_DEVIATION 11.1 | 49.5 years STANDARD_DEVIATION 10.3 |
| Depressive Symptoms | 22.9 units on a scale STANDARD_DEVIATION 10 | 21.8 units on a scale STANDARD_DEVIATION 11.6 | 22.3 units on a scale STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 20 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Minutes of Moderate-to-Vigorous Physical Activity (MVPA) | 14.9 minutes per day STANDARD_DEVIATION 11 | 20.0 minutes per day STANDARD_DEVIATION 14.4 | 17.4 minutes per day STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 23 Participants | 46 Participants |
| Region of Enrollment United States | 25 participants | 26 participants | 51 participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 44 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 26 |
| other Total, other adverse events | 2 / 25 | 1 / 26 |
| serious Total, serious adverse events | 4 / 25 | 0 / 26 |
Outcome results
Primary
Physical Activity Levels
Accelerometry-based moderate-to-vigorous physical activity (MVPA)
Time frame: 8 week assessment
Population: The numbers analyzed include only individuals that provided valid wear-time data on the primary outcome measure, using accelerometry. Specifically, only participants that provided 3 days of 8 hours/day valid wear time were included in the analysis of the primary outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Aerobic Exercise | Physical Activity Levels | 17.4 minutes per day | Standard Deviation 9.8 |
| Sham tDCS and Aerobic Exercise | Physical Activity Levels | 21.0 minutes per day | Standard Deviation 17.4 |
p-value: 0.87ANCOVA