Efficacy of CES in New Mothers During the Post Partum Period

The birth of a child is a major life event that can be filled with excitement, anticipation
and joy. However, the transition and adaptation to new demands, roles, responsibilities, and
changes in relationships can be stressful, especially for first-time mothers. In addition,
new mothers typically encounter physiological changes and struggle with concerns about weight
gain, body image, sexuality, and other physical difficulties such as fatigue. These problems
may generate or exacerbate stress, lead to an actual or perceived crisis and psychological
distress.

Psychological distress, defined as depression, anxiety and insomnia, in this study, often
increases during the postpartum period and can negatively affect maternal mental health
status, maternal and family functioning, and infant-child outcomes. These conditions commonly
present as co-morbidities, but are often unrecognized in clinical practice or under-treated
as co-morbidities in new mothers. This unrecognized cluster of co-morbidities may lead to
psychological distress and subsequently poor outcomes for mothers, their infants and
children.

Current treatment recommendations for depression, anxiety and insomnia are primarily
pharmaceutical or psychotherapy, both of which have limitations related to cost, time
involved and ineffectiveness for some women. Consequently, there is a need to examine other
treatment approaches including complementary modalities, such as cranial electrotherapy
stimulation (CES), particularly in light of current evidence that shows the efficacy of early
detection, intervention and treatment for pregnant and postpartum women.

The primary objective of this study is to investigate the effect of CES on anxiety in new
mothers following childbirth. The secondary objectives are to: (1) determine the effects of
CES on depression and insomnia; (2) explore the effect of CES on maternal functioning in new
mothers following childbirth, and (3) to examine if items 1 & 2 on the 14 item Hamilton
Anxiety Rating Scale (HAM-A14) perform well as a screening test for anxiety. Please see the
enclosed Instrument Description document for detailed information related to this scale.

Inclusion Criteria:

1. Participant must have a total score of ≥ 16 on the HAM-A14 and ≥2 on both Hamilton
Anxiety Rating Scale (HAM-A14) item 1 (anxious mood) and item 2 (tension) at screening
and baseline to be considered for inclusion into the study.

2. Participant is a primiparous new mother, 18-45 years inclusive, who had an
uncomplicated vaginal or cesarean birth, gave birth to a healthy baby and both mother
and baby are healthy at enrollment and randomization in the study.

3. Sexually active female participants of childbearing potential must be self-report
practicing, at least, one or more the following methods of contraception during the
study: intrauterine device (IUD), barrier method in combination with a spermicide,
oral/hormonal contraception or abstinence. Female participants of childbearing
potential must have a negative urine pregnancy test before receiving study treatment.

4. Written informed consent must be obtained from the participant before study
participation.

5. Participant is in good medical health.

6. No current abuse of alcohol or other substance.

7. Capable of giving informed consent.

8. Capable of doing active or sham CES treatments and completing all study requirements
independently

9. For compliance, participants need to have completed 85% (36) of treatments to continue
participation in the study

Exclusion Criteria:

1. Participant had serious complications during or after a vaginal or cesarean delivery.

2. Participant had multiple births.

3. Participant meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-V
criteria for a mental disorder diagnosis (i.e., schizophrenia, mood disorder,
psychosis, anorexia nervosa) as determined by medical history and/or self-report.

4. Participant is clinically judged by the investigator to be at risk for suicide or is
acutely suicidal. Participant has attempted suicide one or more times within the past
twelve months.

5. Participant has a Hamilton Anxiety Rating Scale (HAM-A14) score above 30 which
suggests a very severe clinical level of anxiety symptoms.

6. Participant has a Hamilton Depression Rating Scale (HAM-D17) score above 30 which
suggests a very severe clinical level of depressive symptoms.

7. Participant has a psychiatric condition that would require inpatient or partial
psychiatric hospitalization.

8. Participant has a significant history of medical disease (i.e. cardiovascular, hepatic
(e.g., cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal,
neurological (seizures), gastrointestinal, metabolic, hematological, endocrine, cancer
with a metastatic potential or progressive neurological disorders) which could impair
reliable participation in the trial or necessitate the use of medication not allowed
by this protocol.

9. Participant is pregnant, planning to become pregnant. If a participant becomes
pregnant, she will be dropped from the study immediately and followed appropriately.

10. Participant has had concomitant therapy with another investigational drug, or
participation in an investigational drug study within one month before entering this
study.

11. Participant has a history of poor compliance or in the investigator's judgment any
participant who is not compliant with the requirements of the study.

12. Participant has had previous trial of CES.