The Effect of Cranial Electrotherapy Stimulation as Adjunctive Therapy on Anxiety Disorder in Elderly: an Open-label, Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- The change of subjective anxiety symptom from baseline
Study Overview
Brief Summary
The study aimed to investigate whether cranial electrotherapy stimulation(CES) could benefit anxiety symptoms, depressive symptoms, quality of sleep and quality of life in elderly patients with anxiety disorder.
Detailed Description
Several studies have shown cranial electrotherapy stimulation (CES) could decrease depression and anxiety symptoms in patients with mood disorder. However, none study so far focused on the elderly population to investigate the anti-depressant and anxiolytic effect in elderly patient with anxiety disorder. Hence, this pilot study aims to assess the safety and efficacy of CES on anxiety symptoms, depressive symptoms, sleep quality and life quality in elderly patient with anxiety disorder. The study was an open-label, one arm study. The study aimed to investigate whether cranial electrotherapy stimulation(CES) could benefit anxiety symptoms, depressive symptoms, quality of sleep and quality of life in elderly patients with anxiety disorder.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 60 to 85 years old
- •Anxiety disorder confirmed by Mini-international neuropsychiatric interview (MINI)
- •HAM-A score greater than 17 points
- •HAM-D score lower than 17 points
- •Mini-mental state examination score of 24 or more
- •No psychiatric medication adjustment within 3 months.
Exclusion Criteria
- •Comorbid with another axis I psychiatric disorder, like schizophrenia, substance use disorder or other major mental illness screened by Mini-international neuropsychiatric interview (MINI)
- •Contraindications for CES
- •Implanted brain medical devices or mental in the head
- •History of seizures
- •History of intracranial neoplasm or surgery
- •Severe head injuries
- •Cerebrovascular diseases
- •Arrhythmia or with pacemaker implantation
- •Used to receive brain stimulation therapy.
Arms & Interventions
Received CES intervention
CES with the frequency of 0.5 Hertz; current of 100~600micro-ampere, for 60 minutes, everyday for 6 weeks, total 42 sessions intervention
Intervention: CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA) (Device)
Outcomes
Primary Outcomes
The change of subjective anxiety symptom from baseline
Time Frame: 1. Change from baseline BAI score after the 4 weeks and the 6 weeks. 2.Change from baseline BAI score after 4 weeks (week 10) after the full CES treatment course
evaluate the Beck anxiety inventory (BAI) for subjective anxiety The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are: 0-7: minimal anxiety; 8-15: mild anxiety; 16-25: moderate anxiety; 26-63: severe anxiety.
The change of objective anxiety symptom from baseline
Time Frame: 1.Change from baseline HAM-A score after the 4 weeks and the 6 weeks. 2.Change from baseline HAM-A score after 4 weeks (week 10) after the full CES treatment course
evaluate the Hamilton Anxiety Rating Scale (HAM-A) for objective anxiety Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Secondary Outcomes
- The change of quality of sleep from baseline: Pittsburgh Sleep Quality Index (PSQI)(1. Change from baseline PSQI score after the 4 weeks and the 6 weeks. 2.Change from baseline PSQI score after 4 weeks (week 10) after the full CES treatment course)
- The change of quality of life from baseline: Brief version of World Health Organization Quality of Life questionnaire (WHOQOL-BREF)(1. Change from baseline WHOQOL-BREF score after the 4 weeks and the 6 weeks. 2.Change from baseline WHOQOL-BREF score after 4 weeks (week 10) after the full CES treatment course)
- The change of subjective depressive symptom from baseline(1. Change from baseline BDI-II score after the 4 weeks and the 6 weeks. 2.Change from baseline BDI-II score after 4 weeks (week 10) after the full CES treatment course)
- The change of objective depressive symptom from baseline(1. Change from baseline HAM-D score after the 4 weeks and the 6 weeks. 2.Change from baseline HAM-D score after 4 weeks (week 10) after the full CES treatment course)
Investigators
Che-Sheng Chu
Department of Psychiatry, MD, attending physician
Kaohsiung Veterans General Hospital.