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Efficacy of CES in New Mothers During the Post Partum Period

Primary Purpose

Anxiety, Depression, Insomnia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Alpha-Stim AID CES (Active Comparator)

Alpha-Stim AID CES (Sham Comparator)

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Cranial Electrotherapy Stimulation (CES), Efficacy, Post Partum, Anxiety, Depression, Insomnia, Sleep Quality, Maternal Functioning

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Primay care; OB-GYN Clinic
Primary care; OB-GYN Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Comparator

Sham Comparator

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Hamilton Anxiety Rating Scale Scores Over Time

Hamilton Anxiety Rating Scale (HAM-A14): The HAM-A probes 14 parameters. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe and combined to compute a total score. Higher total scores suggest worse outcomes Total score: 14-17 = Mild Anxiety Total score: 18-24 = Moderate Anxiety Total score: 25-30 = Severe Anxiety

Secondary Outcome Measures

Hamilton Depression Rating Scale Scores Over Time

Hamilton Depression Rating Scale17 (HAM-D17) Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe and combined to compute a total score. Nine items are scored from 0-2. Higher total scores suggest worse outcomes. Total score: 0-7 = Normal Total score: 8-13 = Mild Depression Total score: 14-18 = Moderate Depression Total score: 19-22 = Severe Depression Total score: ≥ 23 = Very Severe Depression 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression ≥ 23 = Very Severe Depression Higher total scores suggests worse outcomes

Pittsburgh Sleep Quality Index Scale Scores Over Time

Pittsburg Sleep Quality Index (PSQI19) A 19-item scale that measures sleep quality during the previous month and discriminates between good and poor sleepers The PSQI19 is a 19-item scale that measures sleep quality during the previous month and discriminates between good and poor sleepers 0 = no difficulty 3 = indicates severe difficulty Seven component scores are then added to yield one "global" score, with a range of 0 = 21 points 0 = indicating no difficulty to 21 = indicating severe difficulties in all areas.

Insomnia Severity Index Scores Over Time

The Insomnia Severity Index (ISI7) Items include: the severity of sleep onset and maintenance (middle and early morning awakening) difficulties, satisfaction with current sleep pattern, interference with daily functioning, appearance of impairment attributed to the sleep problem, and the degree of concern caused by insomnia Total score categories: 0 - 7 = No clinically significant insomnia 8 - 14 = Sub threshold insomnia 15 - 21 = Clinical insomnia (moderate severity) 22 - 28 = Clinical insomnia (severe) Higher scores indicate worse outcomes

Barkin Index of Maternal Functioning Scores Over Time

Barkin Index of Maternal Functioning (BIMF20) The Barkin Index of Maternal Functioning (BIMF) is a 20-item self-report measure that was designed to assess overall functioning in the context of new motherhood. After reverse-coding for items 16 and 18, the BIMF is scored by simply summing all 20 items. Total score ranges from 0 to 120 Higher scores represent better outcomes

Full Information

NCT ID

NCT03210155

First Posted

June 25, 2017

Last Updated

July 31, 2020

Sponsor

Christina Murphey, RN, PhD

1. Study Identification

Unique Protocol Identification Number

NCT03210155

Brief Title

Efficacy of CES in New Mothers During the Post Partum Period

Official Title

Effects of Cranial Electrotherapy Stimulation on Psychological Distress and Maternal Functioning in New Mothers During the Postpartum Period

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Terminated

Why Stopped

Early termination due to change in recruitment site and search team members

Study Start Date

July 24, 2017 (Actual)

Primary Completion Date

August 1, 2019 (Actual)

Study Completion Date

August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Christina Murphey, RN, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression, Insomnia, Sleep Quality

Keywords

Cranial Electrotherapy Stimulation (CES), Efficacy, Post Partum, Anxiety, Depression, Insomnia, Sleep Quality, Maternal Functioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The blocked randomization method will be used to assign participants to active and sham groups. Participants will be assigned to CES treatment or sham CES using a 1:1 ratio. Electromedical Products International, Inc. (EPI) will randomize the assignment of appropriate devices to active or sham groups by using a random list of computer generated numbers (1 for active and 2 for sham) in randomly selected block sizes. The PI and participants are blinded to which participants have Alpha-Stim® CES active or sham devices until data analysis is complete. After the completion of data analysis, blinding will be broken.

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Comparator

Arm Type

Active Comparator

Arm Description

Arm Title

Sham Comparator

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Alpha-Stim AID CES (Active Comparator)

Other Intervention Name(s)

Alpha-Stim AID

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Alpha-Stim AID CES (Sham Comparator)

Other Intervention Name(s)

Alpha-Stim AID

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hamilton Anxiety Rating Scale Scores Over Time

Description

Time Frame

T1 (Baseline); T2 (3 weeks); T3 (6 Weeks)

Secondary Outcome Measure Information:

Title

Hamilton Depression Rating Scale Scores Over Time

Description

Time Frame

T1 (Baseline); T2 (3 weeks); T3 (6 Weeks)

Title

Pittsburgh Sleep Quality Index Scale Scores Over Time

Description

Time Frame

T1 (Baseline); T2 (3 weeks); T3 (6 weeks)

Title

Insomnia Severity Index Scores Over Time

Description

Time Frame

T1 (baseline); T2 (3 weeks); T3 (6 weeks)

Title

Barkin Index of Maternal Functioning Scores Over Time

Description

Time Frame

T1 (baseline); T2 (3 weeks); T3 (6 weeks)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina Murphey, RN, PhD

Organizational Affiliation

Texas A&M University Corpus Christi

Official's Role

Principal Investigator

Facility Information:

Facility Name

Primay care; OB-GYN Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78758

Country

United States

Facility Name

Primary care; OB-GYN Clinic

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78412

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28191350

Citation

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.

Results Reference

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Efficacy of CES in New Mothers During the Post Partum Period

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