SMILES: The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series
Study Details
Study Description
Brief Summary
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:
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Is it feasible to recruit a sufficient number of participants?
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Is it feasible to administer Perinatal SMILES and
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Is it feasible to collect participant outcomes?
Participants will:
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Complete five sessions of interpersonal therapy
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Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day
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Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection
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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
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Complete mood assessments over the first 12 postpartum weeks
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Interpersonal psychotherapy plus ketamine Five sessions of interpersonal psychotherapy (IPT) and pre-, and post-, ketamine sessions b) Two doses of subcutaneous (SC) ketamine in the first 4 post-cesarean days |
Behavioral: interpersonal psychotherapy (IPT)
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.
Other Names:
Drug: Ketamine
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).
Other Names:
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Outcome Measures
Primary Outcome Measures
- Depressive symptoms [through postoperative day 84]
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.
- P30 (TMS-evoked potential) [4 days]
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.
- N45 (TMS-evoked potential) [4 days]
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.
- P60 (TMS-evoked potential) [4 days]
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.
- N100 (TMS-evoked potential) [4 days]
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.
- Local mean field amplitude-area under the curve (LMFA-AUC) [4 days]
This will be assessed by examining the TMS-evoked EEG
- Anxiety [through postoperative day 84]
This will be assessed using the General Anxiety Disorder-7 (GAD-7) questionnaire.
- Psychosocial stress [at enrollment 1 day]
This will be assessed using the Antenatal Risk Questionnaire (ANRQ)
- Post-Traumatic Stress Disorder (PTSD) [through postoperative day 84]
The Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire.
- Breastfeeding success [4 days]
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.
- Adverse effects - sedation [4 days]
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation.
- Adverse effects - Blurred vision [4 days]
Will be assessed on a four point scale (Not present, mild, moderate, severe): blurred vision.
- Adverse effects - diplopia [4 days]
Will be assessed on a four point scale (Not present, mild, moderate, severe): diplopia.
- Adverse effects - dizziness [4 days]
Will be assessed on a four point scale (Not present, mild, moderate, severe): dizziness.
- Adverse effects - euphoria [4 days]
Will be assessed on a four point scale (Not present, mild, moderate, severe): euphoria.
- Adverse effects - amnesia [4 days]
Each of the following will be assessed on a four point scale (Not present, mild, moderate, severe): amnesia.
- Adverse effects - hallucinations [4 days]
Will be assessed on a four point scale (Not present, mild, moderate, severe): hallucinations.
- Adverse effects - nystamus [4 days]
Will be assessed on a four point scale (Not present, mild, moderate, severe): nystagmus.
- Adverse effects [4 days]
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation, blurred vision, diplopia, dizziness, euphoria, amnesia, hallucinations, nystagmus.
- Antidepressant treatment [through postoperative day 84]
All current pharmacological and psychological therapies will be documented.
Eligibility Criteria
Criteria
Inclusion Criteria
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English-speaking (necessary for IPT under the limitations of the pilot)
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Socio-economically disadvantaged (i.e., low-income requiring public assistance)
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Suffering with depressive symptoms (EPDS > 10) -> 20 - 32 weeks pregnant and scheduled for cesarean delivery" or "within 48 hours of an unscheduled (or scheduled) cesarean delivery.
Exclusion Criteria
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An allergy to ketamine
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Contraindications for TMS including the presence of metallic objects within 30 cm of the TMS coil, intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; presence of intracardiac lines, defibrillators or a cardiac pacemaker and unable to assess safety; presence of implanted electronic devices that control physiologic functions and unable to assess safety
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Have a personal history of a primary seizure disorder or a seizure associated with an intracranial lesion
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History of severe head trauma or neurological disorders (e.g., pre-eclampsia) that substantially increase seizure risk, per PI discretion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barnes-Jewish Hospital | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: David Monks, MBCHB, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202306156