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Behavioral Intervention
tACS + Behavioral Activation for Depression (ABBA Trial)
N/A
Recruiting
Led By Flavio Frohlich, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years old or order
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to follow-up 2 weeks post treatment
Awards & highlights
ABBA Trial Summary
This trial tests a new type of brain stimulation to see if it boosts the effect of therapy in people with depression.
Who is the study for?
This trial is for English-speaking adults with major depressive disorder, as confirmed by the MINI. They must understand and consent to study procedures and be available throughout the study. Exclusions include recent brain injury or surgery, severe substance use disorders, active psychosis, ongoing psychotherapy or brain stimulation treatments within the last month, unstable psychotropic medication use, pregnancy/breastfeeding, and certain medical/neurological conditions.Check my eligibility
What is being tested?
The trial tests if delta-beta transcranial alternating current stimulation (tACS) can boost a single session of behavioral activation therapy for depression. Participants will receive either real tACS or a sham (inactive) version alongside their therapy session to compare effects.See study design
What are the potential side effects?
Potential side effects from tACS may include mild discomfort at the electrode sites on the scalp during stimulation, headache after treatment sessions, fatigue or dizziness. However, these are typically temporary and resolve shortly after each session.
ABBA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
ABBA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to follow-up 2 weeks post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to follow-up 2 weeks post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in clinician-rated depressive symptoms
Secondary outcome measures
Change in percentage of hard trials chosen during the S-EEfRT
Change in phase-amplitude coupling between delta-beta oscillations during task performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT)
Other outcome measures
Change in clinician-rated anhedonia symptoms using SHAPS-C
ABBA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Delta-beta tACSExperimental Treatment2 Interventions
Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. Stimulation will be delivered via the NeuroConn DC-STIMULATOR MC at 1 milliampere (mA) zero-to-peak amplitude at the target electrodes and 2 mA zero to-peak amplitude at the return electrode. The tACS will be delivered using the cross-frequency stimulation waveform delta-beta (3-20Hz).
Group II: Active-sham tACSPlacebo Group2 Interventions
Participants will receive a single session intervention of behavioral activation (BA) psychotherapy. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS, assisting with blinding the participant's assignment.
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,785 Total Patients Enrolled
55 Trials studying Depression
33,698 Patients Enrolled for Depression
Foundation of Hope, North CarolinaOTHER
15 Previous Clinical Trials
512 Total Patients Enrolled
6 Trials studying Depression
165 Patients Enrolled for Depression
Flavio Frohlich, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
19 Previous Clinical Trials
679 Total Patients Enrolled
2 Trials studying Depression
116 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any health conditions that could affect my participation in the study.My dose of psychiatric medication has been stable for 4 weeks and won't change soon.You are capable of granting informed consent.I haven't had psychotherapy or brain stimulation treatments in the last 4 weeks.I have not had brain surgery before.I do not need treatment for a past brain injury.I am not pregnant or breastfeeding.You are willing to abide by all research mandates and be present throughout the experiment.I have not had a brain injury or concussion in the last three months.You can converse and comprehend English.You have been diagnosed with Major Depressive Disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), as determined by the Mini International Neuropsychiatric Interview.You should not have any current thoughts or plans of hurting yourself, as determined by a questionnaire called the Columbia Suicide Severity Rating Scale (C-SSRS).I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Active-sham tACS
- Group 2: Delta-beta tACS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available for participants in this experiment?
"According to clinicaltrials.gov, this research endeavour is not presently enrolling participants; the trial was originally listed on January 1st 2023 and last updated on November 11th 2023. However, there are 829 other trials across the world that are actively recruiting patients right now."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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