Back to resultsAugmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression (ABBA)
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC
Single-session behavioral activation
Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring transcranial alternating current stimulation, cross-frequency coupling, behavioral activation
Eligibility Criteria
Inclusion Criteria: 18 years old or order Able to provide informed consent Willing to comply with all study procedures and be available for the duration of the study Speak and understand English DSM-5 diagnosis of major depressive disorder (MDD) as assessed by the MINI Exclusion Criteria: Participants must not have active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS). Active suicide intent will be captured in responses to items 4 and/or 5 on the C-SSRS. Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as captured by the MINI. Participants may not currently be in psychotherapy and have not received any other psychotherapy and/or stimulation (ECT, TMS) within the last 4 weeks. Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks. (for female participants) Participants must not be pregnant or breastfeeding. Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation Participants may not have undergone prior brain surgery Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips Participants may not have had brain injury or concussion within the last three months Participants may not have a history of brain injury requiring current treatment
Sites / Locations
- University of North Carolina at Chapel HillRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Delta-beta tACS
Active-sham tACS
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Change in clinician-rated depressive symptoms
Treatment response will be calculated as the change in clinician rated depression symptom scores using the Hamilton Depression Rating Scale (HDRS). Items are scaled either from 0 - 2 to 0 - 4, and each item is summed for a total score. Benchmarks suggested at: 0-7 normal; 8 - 13 mild depression; 14-18 moderate depression; 19-22 severe depression; >=23 very severe depression.
Secondary Outcome Measures
Change in phase-amplitude coupling between delta-beta oscillations during task performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT)
In the Streamlined Expenditure of Effort for Reward Task (S-EEfRT), participants choose to complete a HARD task requiring many button presses or an EASY task with fewer button presses for variable monetary incentives. Number of button presses is individualized for each participant.
Delta-beta coupling during the HARD/EASY decision will be calculated between the phase of delta oscillations (2-3Hz) in prefrontal electrodes (FCz and surrounding electrodes) and the amplitude of beta oscillations (15-25Hz) in left motor electrodes (C3 and surrounding electrodes). The instantaneous phase and amplitude of these oscillations will be calculated by averaging the signal in these two regions, band-filtering the signal to the specified range, and then performing the Hilbert transform on the signal. Phase-amplitude coupling (PAC) is calculated by creating a hybrid signal using the beta oscillation amplitude in left motor electrodes and the delta oscillation phase in prefrontal electrodes.
Change in percentage of hard trials chosen during the S-EEfRT
In the Streamlined Expenditure of Effort for Reward Task (S-EEfRT), participants choose to complete a HARD task requiring many button presses or an EASY task with fewer button presses for variable monetary incentives. Number of button presses is individualized for each participant.
Goal-directed behavior will be calculated as the average decision to perform the HARD task across trials.
Full Information
NCT ID
NCT05693922
First Posted
January 11, 2023
Last Updated
July 25, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Foundation of Hope, North Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05693922
Brief Title
Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression
Acronym
ABBA
Official Title
Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Foundation of Hope, North Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigating whether delta-beta cross-frequency transcranial alternating current stimulation can augment the effects of a single session of behavioral activation in participants with major depressive disorder.
Detailed Description
The purpose of this study is to examine whether concurrent transcranial alternating current stimulation (tACS) augments the effects of a single session behavioral activation (BA) treatment of depression. Following a series of clinical assessments, participants will perform a reward-based decision-making task while electroencephalography (EEG) is collected.
Then, all participants will take part in a single-session 90-minute BA intervention; half of the participants will receive delta-beta tACS during the final 30 minutes of the session and half will receive an active sham stimulation. Participants will return two weeks later for another task-based EEG. Four weeks after the intervention session, they will receive self-report questionnaires via email to complete online.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
transcranial alternating current stimulation, cross-frequency coupling, behavioral activation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will take part in a single-session behavioral activation (BA) intervention. To examine the effects of neurostimulation on treatment response, participants will be randomized to receive either delta-beta cross-frequency transcranial alternating current stimulation (tACS) or an active sham.
Masking
ParticipantInvestigator
Masking Description
This study is designed to be double-blind. This means that the participant and the researchers are unaware of each participant's assignment until the completion of all data collection. This is accomplished using the randomization codes described above. Furthermore, this study utilizes an active sham stimulation. The active sham condition includes brief stimulation, mimicking the skin sensations associated with tACS. In our previously concluded trial, participants in the delta-beta tACS and active sham groups responded similarly to the blinding questionnaire, indicating that our active sham stimulation successfully blinded the participants.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Delta-beta tACS
Arm Type
Experimental
Arm Description
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).
Arm Title
Active-sham tACS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Delta-beta cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC
Intervention Description
Delta-beta stimulation will be delivered via the NeuroConn DC-STIMULATOR MC, an investigational electrical non-invasive brain stimulation device that is being used for foundational neuroscience and translational research.
Intervention Type
Behavioral
Intervention Name(s)
Single-session behavioral activation
Intervention Description
Participants will take part in a single-session behavioral activation (BA) intervention. This intervention was adapted from standard BA protocols for the treatment of depression to be completed in a single, 90-minute session. This intervention will have 4 main components based on prior protocols:
Treatment overview and rationale
Tracking of daily activities
Exploration of values
Planning/scheduling activities
Intervention Type
Device
Intervention Name(s)
Active sham cross-frequency transcranial alternating current stimulation via the NeuroConn DC-STIMULATOR MC
Intervention Description
Active sham stimulation will be delivered via the NeuroConn DC-STIMULATOR MC, an investigational electrical non-invasive brain stimulation device that is being used for foundational neuroscience and translational research.
Primary Outcome Measure Information:
Title
Change in clinician-rated depressive symptoms
Description
Treatment response will be calculated as the change in clinician rated depression symptom scores using the Hamilton Depression Rating Scale (HDRS). Items are scaled either from 0 - 2 to 0 - 4, and each item is summed for a total score. Benchmarks suggested at: 0-7 normal; 8 - 13 mild depression; 14-18 moderate depression; 19-22 severe depression; >=23 very severe depression.
Time Frame
Baseline up to follow-up 2 weeks post treatment
Secondary Outcome Measure Information:
Title
Change in phase-amplitude coupling between delta-beta oscillations during task performance of the Streamlined Expenditure of Effort for Reward Task (S-EEfRT)
Description
In the Streamlined Expenditure of Effort for Reward Task (S-EEfRT), participants choose to complete a HARD task requiring many button presses or an EASY task with fewer button presses for variable monetary incentives. Number of button presses is individualized for each participant.
Delta-beta coupling during the HARD/EASY decision will be calculated between the phase of delta oscillations (2-3Hz) in prefrontal electrodes (FCz and surrounding electrodes) and the amplitude of beta oscillations (15-25Hz) in left motor electrodes (C3 and surrounding electrodes). The instantaneous phase and amplitude of these oscillations will be calculated by averaging the signal in these two regions, band-filtering the signal to the specified range, and then performing the Hilbert transform on the signal. Phase-amplitude coupling (PAC) is calculated by creating a hybrid signal using the beta oscillation amplitude in left motor electrodes and the delta oscillation phase in prefrontal electrodes.
Time Frame
Baseline up to follow-up 2 weeks post treatment
Title
Change in percentage of hard trials chosen during the S-EEfRT
Description
In the Streamlined Expenditure of Effort for Reward Task (S-EEfRT), participants choose to complete a HARD task requiring many button presses or an EASY task with fewer button presses for variable monetary incentives. Number of button presses is individualized for each participant.
Goal-directed behavior will be calculated as the average decision to perform the HARD task across trials.
Time Frame
Baseline up to follow-up 2 weeks post treatment
Other Pre-specified Outcome Measures:
Title
Change in clinician-rated anhedonia symptoms using SHAPS-C
Description
The Snaith-Hamilton Pleasure Scale-Clinician (SHAPS-C) is a clinician administered tool to assess symptoms of anhedonia. The SHAPS-C items use a Likert scale of 1-4, with higher scores reflecting greater pathology.
Time Frame
Baseline up to follow-up 2 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years old or order
Able to provide informed consent
Willing to comply with all study procedures and be available for the duration of the study
Speak and understand English
DSM-5 diagnosis of major depressive disorder (MDD) as assessed by the MINI
Exclusion Criteria:
Participants must not have active suicide intent as determined by the Columbia Suicide Severity Rating Scale (C-SSRS). Active suicide intent will be captured in responses to items 4 and/or 5 on the C-SSRS.
Participants must not meet criteria for current severe substance use disorder, anorexia nervosa, or active psychosis as captured by the MINI.
Participants may not currently be in psychotherapy and have not received any other psychotherapy and/or stimulation (ECT, TMS) within the last 4 weeks.
Any participants taking psychotropic medication must be on a stable dose for at least 4 weeks with no planned dose changes within the next 4 weeks.
(for female participants) Participants must not be pregnant or breastfeeding.
Participants may not have any medical or neurological illness for which symptom presentation or treatment could interfere with study participation
Participants may not have undergone prior brain surgery
Participants may not have any brain devices/implants, including cochlear implants and aneurysm clips
Participants may not have had brain injury or concussion within the last three months
Participants may not have a history of brain injury requiring current treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Bondy, MA
Phone
919-843-7694
Email
erin_bondy@med.unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Flavio Frohlich, PhD
Phone
919-966-4584
Email
flavio_frohlich@med.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavio Frohlich, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavio Frohlich, PhD
Phone
919-966-4584
Email
flavio_frohlich@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Flavio Frohlich, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD Sharing Time Frame
beginning 9 and continuing for 36 months following publication
IPD Sharing Access Criteria
Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Learn more about this trial
Augmenting Single-session Behavioral Activation (BA) With Delta-beta Transcranial Alternating Current Stimulation (tACS) for the Treatment of Depression
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