Status:
WITHDRAWN
New Mothers Alpha-Stim
Lead Sponsor:
Christina Murphey, RN, PhD
Conditions:
Anxiety
Depression
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
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 rela...
Detailed Description
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 rela...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
- Written informed consent must be obtained from the participant before study participation.
- Participant is in good medical health.
- No current abuse of alcohol or other substance.
- Capable of giving informed consent.
- Capable of doing active or sham CES treatments and completing all study requirements independently
- For compliance, participants need to have completed 85% (36) of treatments to continue participation in the study
Exclusion
- Participant had serious complications during or after a vaginal or cesarean delivery.
- Participant had multiple births.
- 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.
- 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.
- Participant has a Hamilton Anxiety Rating Scale (HAM-A14) score above 30 which suggests a very severe clinical level of anxiety symptoms.
- Participant has a Hamilton Depression Rating Scale (HAM-D17) score above 30 which suggests a very severe clinical level of depressive symptoms.
- Participant has a psychiatric condition that would require inpatient or partial psychiatric hospitalization.
- 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.
- Participant is pregnant, planning to become pregnant. If a participant becomes pregnant, she will be dropped from the study immediately and followed appropriately.
- Participant has had concomitant therapy with another investigational drug, or participation in an investigational drug study within one month before entering this study.
- 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.
- Participant has had previous trial of CES.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04770181
Start Date
November 1 2024
End Date
August 1 2026
Last Update
April 27 2025
Active Locations (2)
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1
Primay care; OB-GYN Clinic
Austin, Texas, United States, 78758
2
Primary care; OB-GYN Clinic
Corpus Christi, Texas, United States, 78412