AnxietyNCT04770181
New Mothers Alpha-Stim
A study testing Alpha-Stim AID CES (Active Comparator) in people with Anxiety and Depression, run by Christina Murphey, RN, PhD at 2 sites in United States.
Trial 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 relationships can be stressful, especially for new mothers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Insomnia
- What is being tested?
- Alpha-Stim AID CES (Active Comparator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Primay care; OB-GYN Clinic
Austin, Texas, 78758
Primary care; OB-GYN Clinic
Corpus Christi, Texas, 78412
About this study
Official title: Effects of Cranial Electrotherapy Stimulation on Psychological Distress and Maternal Functioning in New Mothers During the Postpartum 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 new 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 anxiety, depression, and insomnia, in this study, often increases during the postpartum period and can negatively affect maternal mental health status, maternal and family relationships, and infant-child health. The purpose of this study is to evaluate the effects of cranial electrotherapy stimulation (CES) on anxiety, insomnia, depression, and maternal functioning in first time new mothers following childbirth.
Read the 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 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.
- Conditions
- Anxiety, Depression, Insomnia, Sleep Quality
- Being tested
- Alpha-Stim AID CES (Active Comparator), Alpha-Stim AID CES (Sham Comparator)
- Keywords
- Cranial Electrotherapy Stimulation (CES), Efficacy, Post Partum, Anxiety, Depression, Insomnia, Sleep Quality, Maternal Functioning
- Medical subject headings
- Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-Stim AID CES (Active Comparator)Device
Also called Alpha-Stim AID
The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
Alpha-Stim AID CES (Sham Comparator)Device
Also called Alpha-Stim AID
The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level). Receives: Device: Alpha-Stim AID CES (Active Comparator) |
| Sham Comparator | Sham comparator | The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks. Receives: Device: Alpha-Stim AID CES (Sham Comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the effect of CES on anxiety in new mothers during the postpartum period.
The Hamilton Anxiety Rating Scale (HAM-A14)
Measured: Duration is six weeks
Secondary outcomes (3)
To measure the effect of CES on depression in new mothers during the postpartum period.
The Hamilton Depression Rating Scale17 (HAM-D17)
Measured: Duration is six weeks
To measure the effect of CES on sleep quality in new mothers during the postpartum period.
The Pittsburgh Sleep Quality Index (PSQI19)
Measured: Duration is six weeks
To measure the effect of CES on insomnia in new mothers during the postpartum period.
The Insomnia Severity Index (ISI7)
Measured: Duration is six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study startNov 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: No participants were enrolled and will not be restarted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design for the proposed study is a matched-pair, quasi-experimental, 1:1 randomized, double-blind, sham-controlled clinical trial with a longitudinal component. The analytic technique employed to answer the research questions will be repeated measures analysis of covariance.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christina Murphey, RN, PhD
- Responsible party
- Sponsor-investigator, Christina Murphey, RN, PhD, Murphey, Christina, RN, PhD
- Investigators
- Christina Murphey, RN, PhD, Principal investigator, Texas A&M University - Corpus Christi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770181
- Sponsor's protocol ID
- DCHIRB#00001244
- Status last verified
- Nov 2024
- First submitted
- 22 Feb 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Murphey C, Carter P, Price LR, Champion JD, Nichols F. Psychological Distress in Healthy Low-Risk First-Time Mothers during the Postpartum Period: An Exploratory Study. Nurs Res Pract. 2017;2017:8415083. doi: 10.1155/2017/8415083. Epub 2017 Jan 16.
PubMed 28191350
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cranial Electrotherapy Stimulation on Psychological Distress and Maternal Functioning in New Mothers During the Postpartum Period
- ClinicalTrials.gov ID
- NCT04770181
- Acronym / sponsor ID
- DCHIRB#00001244
- Conditions
- Anxiety, Depression, Insomnia, Sleep Quality
- Keywords
- Cranial Electrotherapy Stimulation (CES), Efficacy, Post Partum, Anxiety, Depression, Insomnia, Sleep Quality, Maternal Functioning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled and will not be restarted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christina Murphey, RN, PhD
- Study start
- Nov 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 new 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 anxiety, depression, and insomnia, in this study, often increases during the postpartum period and can negatively affect maternal mental health status, maternal and family relationships, and infant-child health. The purpose of this study is to evaluate the effects of cranial electrotherapy stimulation (CES) on anxiety, insomnia, depression, and maternal functioning in first time new mothers following childbirth.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The design for the proposed study is a matched-pair, quasi-experimental, 1:1 randomized, double-blind, sham-controlled clinical trial with a longitudinal component. The analytic technique employed to answer the research questions will be repeated measures analysis of covariance.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Device: Alpha-Stim AID CES (Active Comparator)About the size of a smart phone, the Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The active intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level). |
| Sham Comparator | Sham comparator | Device: Alpha-Stim AID CES (Sham Comparator)The Alpha-Stim® AID CES sham device is identical in appearance to the active device but is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham intervention is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-Stim AID CES (Active Comparator)Also: Alpha-Stim AIDThe Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level). | Device | Active Comparator |
| Alpha-Stim AID CES (Sham Comparator)Also: Alpha-Stim AIDThe Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks. | Device | Sham Comparator |
Primary outcome
To measure the effect of CES on anxiety in new mothers during the postpartum period.
Time frame: Duration is six weeks
The Hamilton Anxiety Rating Scale (HAM-A14)
3 secondary outcomes
To measure the effect of CES on depression in new mothers during the postpartum period.
Time frame: Duration is six weeks
To measure the effect of CES on sleep quality in new mothers during the postpartum period.
Time frame: Duration is six weeks
To measure the effect of CES on insomnia in new mothers during the postpartum period.
Time frame: Duration is six weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 28191350Murphey C, Carter P, Price LR, Champion JD, Nichols F. Psychological Distress in Healthy Low-Risk First-Time Mothers during the Postpartum Period: An Exploratory Study. Nurs Res Pract. 2017;2017:8415083. doi: 10.1155/2017/8415083. Epub 2017 Jan 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Murphey, RN, PhD principal investigator
Texas A&M University - Corpus Christi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-Stim AID CES (Active Comparator) in people with Anxiety and Depression, run by Christina Murphey, RN, PhD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the effect of CES on anxiety in new mothers during the postpartum period. (time frame: Duration is six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04770181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025; AzTrials last refreshed its copy on 29 Oct 2026.