Adults 18 to 45, female only, with Anxiety or Depression. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hamilton Anxiety Rating Scale Scores Over TimePrimary· T1 (Baseline); T2 (3 weeks); T3 (6 Weeks)
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
T1
Group
Value
95% CI
Sham Comparator
15
T2
Group
Value
95% CI
Sham Comparator
15
T3
Group
Value
95% CI
Sham Comparator
14
Hamilton Depression Rating Scale Scores Over TimeSecondary· T1 (Baseline); T2 (3 weeks); T3 (6 Weeks)
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 = Ver
T1
Group
Value
95% CI
Sham Comparator
7
T2
Group
Value
95% CI
Sham Comparator
7
T3
Group
Value
95% CI
Sham Comparator
8
Pittsburgh Sleep Quality Index Scale Scores Over TimeSecondary· T1 (Baseline); T2 (3 weeks); T3 (6 weeks)
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.
T1
Group
Value
95% CI
Sham Comparator
8
T2
Group
Value
95% CI
Sham Comparator
7
T3
Group
Value
95% CI
Sham Comparator
6
Insomnia Severity Index Scores Over TimeSecondary· T1 (baseline); T2 (3 weeks); T3 (6 weeks)
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
T1
Group
Value
95% CI
Sham Comparator
1
T2
Group
Value
95% CI
Sham Comparator
2
T3
Group
Value
95% CI
Sham Comparator
5
Barkin Index of Maternal Functioning Scores Over TimeSecondary· T1 (baseline); T2 (3 weeks); T3 (6 weeks)
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
T1
Group
Value
95% CI
Sham Comparator
93
T2
Group
Value
95% CI
Sham Comparator
97
T3
Group
Value
95% CI
Sham Comparator
92
Sponsor's own 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 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Christina Murphey, RN, PhD
Last refreshed: 17 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03210155.