The goal of this open label case series is to learn about the feasibility of conducting a future randomised controlled trial to evaluate how well the Perinatal SMILES intervention works in improving post-cesarean mood in low-income women. The main questions it aims to answer are: 1. Is it feasible to recruit a sufficient number of participants? 2. Is it feasible to administer Perinatal SMILES and 3. Is it feasible to collect participant outcomes? To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine Participants will: 1. Complete five sessions of interpersonal therapy 2. Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day 3. Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection 4. Undergo assessments of brain electrical activity (at rest and evoked by trans-cranial magnetic stimulation) before and at three timepoints in the 10 hours after each ketamine injection 5. Complete mood assessments over the first 12 postpartum weeks
The investigators will perform an open-label case series to evaluate the feasibility of performing a trial of a novel intervention to reduce postpartum depression symptoms after cesarean delivery. The intervention, Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms), combines interpersonal therapy with subcutaneous ketamine therapy. The interpersonal therapy consists of five sessions that will be administered during the antepartum and/or postpartum. The ketamine therapy will be administered as two injections, approximately 24 hours apart, in the first four postpartum days and will be preceded and followed by additional therapy sessions. The investigators will assess brain electronic activity before and after the ketamine injections and mood in the first 12 postpartum weeks. The objective is to determine the feasibility of recruiting participant, administering the intervention and collect the outcome data.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
The ROSE intervention is a five-session intervention developed to build communication skills, improve social support, and improve stress management. It is easy to learn and does not require a healthcare professional or mental health specialist to deliver. For this study, the investigators plan to deliver to individuals during inpatient visits, in-person appointments or via telemedicine (phone or videoconference), as appropriate or per participant preference. The first four sessions are approximately 60 minutes in length.
During the first four post-cesarean days, the investigators will administer subcutaneous ketamine (0.5 mg/kg) and a repeated dose of 0.5 or 0.7 mg/kg \~24 hours later (the second dose will be increased to 0.7 mg/kg if no severe adverse effects are reported after the first dose and the patient is in agreement with the dose escalation).
Barnes-Jewish Hospital
St Louis, Missouri, United States
Depressive symptoms
These will be assessed using the Edinburgh Postpartum Depression Scale (EDPS) questionnaire.30 The EPDS is a set of ten questions about the subject's mood in the previous seven days. Each symptom is scored on a numeric rating scale of none (0) to severe (3). Commonly employed thresholds for psychiatric referral are 10-13 out of a possible 30 points.
Time frame: through postoperative day 84
P30 (TMS-evoked potential)
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Time frame: 4 days
N45 (TMS-evoked potential)
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Time frame: 4 days
P60 (TMS-evoked potential)
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Time frame: 4 days
N100 (TMS-evoked potential)
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Time frame: 4 days
Cortical evoked activity (CEA)
The CEA will be calculated from the area under the curve of the rectified single pulse TMS-evoked potential
Time frame: 4 days
Anxiety
This will be assessed using the General Anxiety Disorder-7 (GAD-7) questionnaire. There are 7 items scored from 0-3. The total score can range from 0 (no anxiety) - 21 (most anxiety).
Time frame: through postoperative day 84
Psychosocial stress
This will be assessed using the Antenatal Risk Questionnaire (ANRQ). The range of scores is 5-60. A higher score indicates greater psychosocial risk.
Time frame: at enrollment 1 day
Post-Traumatic Stress Disorder (PTSD)
The Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire. Scores range 0 - 80. More severe PTSD scores higher.
Time frame: through postoperative day 84
Obstetric Quality of Recovery
(ObsQoR10 score, 10 items, total score 0-100)
Time frame: through postoperative day 84
Number of participants who successfully breastfeed their newborn baby
Success in any 24-hour period will be defined as when an infant breastfeeds, for 10 minutes or more in a rhythmic suck/swallow/pause/suck pattern, at least eight times in that 24-hour period.
Time frame: 4 days
Adverse effects - sedation
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation.
Time frame: 4 days
Adverse effects - Blurred vision
Will be assessed on a four point scale (Not present, mild, moderate, severe): blurred vision.
Time frame: 4 days
Adverse effects - diplopia
Will be assessed on a four point scale (Not present, mild, moderate, severe): diplopia.
Time frame: 4 days
Adverse effects - dizziness
Will be assessed on a four point scale (Not present, mild, moderate, severe): dizziness.
Time frame: 4 days
Adverse effects - euphoria
Will be assessed on a four point scale (Not present, mild, moderate, severe): euphoria.
Time frame: 4 days
Adverse effects - amnesia
Each of the following will be assessed on a four point scale (Not present, mild, moderate, severe): amnesia.
Time frame: 4 days
Adverse effects - hallucinations
Will be assessed on a four point scale (Not present, mild, moderate, severe): hallucinations.
Time frame: 4 days
Adverse effects - nystamus
Will be assessed on a four point scale (Not present, mild, moderate, severe): nystagmus.
Time frame: 4 days
Antidepressant treatment
All current pharmacological and psychological therapies will be documented.
Time frame: through postoperative day 84
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