The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach in antenatal depression.
Female aged 18 - 45
Capacity to understand all relevant risks and potential benefits of the study as determined by study staff (provision of informed consent)
Stated willingness to comply with all study procedures and availability for the duration of the study
Low suicide risk (defined for this study as no active suicidal ideation in the past month and no suicide attempts, preparatory actions, or significant non-suicidal self-harm in the previous 2 years). Risk will be assessed utilizing the C-SSRS screen and triage version with further exploration of positive responses.
DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months, as evidenced by the DIAMOND
DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months, as evidenced by the DIAMOND
Lifetime history of bipolar disorder, as evidenced by DIAMOND
Schizophrenia spectrum and other psychotic disorders, as evidenced by DIAMOND
Sequential
tACS (aperiodic)
DeviceIndividualized tACS waveform based on aperiodic EEG activity will be delivered.
Safety via the presence of any serious AEs related to stimulation
The number of serious adverse events reported in healthy control and antenatal depression groups.
Feasibility via the number of participants enrolled relative to the target recruitment in each group
The number of participants enrolled relative to the target recruitment of five participants in each of the healthy control and antenatal depression groups over the specified 12-month period
Feasibility via the number of participants completing all study visits within the intervention and follow-up period
The number of participants who complete all study visits within the intervention and follow-up period in the healthy control and antenatal depression groups.
Tolerability via the proportion of participants rating stimulation-related sensations as 'high'
The number of participants who rate stimulation-related sensations as 'high' within the intervention period in the healthy control and antenatal depression groups.
Change in aperiodic exponent following the five-day PandA-tACS intervention
The change in aperiodic exponent from resting state EEG recordings on the first day and the final day of stimulation in healthy control and antenatal depression populations.
Change in HDRS-17 score following intervention in the antenatal depression population
The HDRS-17 is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 52. A higher score indicates a worse outcome. Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1
Change in Edinburgh Postnatal Depression Scale (EPDS) in the antenatal depression population
The EPDS is a self-administered questionnaire designed to screen for potential symptoms of depression during pregnancy and the postpartum period. This scale consists of 10 short statements, where the participant checks off one of four possible answers about how they have been feeling for the past week. Responses are scored from 0-3, where total scores above 12 or 13 are likely to be suffering from depression. Investigators will determine the change in scores between across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.
Change in Snaith-Hamilton Pleasure Scale (SHAPS) in the antenatal depression population
The SHAPS is a 14-item scale which assesses for anhedonia (the inability to experience pleasure) where each item has a set of four response categories (definitely agree=1, agree=2, disagree=3, definitely disagree=4). Participants are considered to be experiencing mild anhedonia if they disagree with three or more statements. Participants can agree or disagree on a minimum of 0 and maximum of 14 statements. Investigators will determine the change in scores across the intervention from Day 1 to Day 5, Day 1 to Follow-up 1, Day 5 to Follow-up 1.
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University of North Carolina, Chapel Hill
Lead sponsor
Brain & Behavior Research Foundation
Collaborator
Michigan State University
Collaborator
