Clinical trial NCT06966921: The Effect of Cranial Electrotherapy Stimulation on the Cognition, Anxiety, Depression and Sleep Quality of Chronic Psychiatric Patients
Official title: The Effect of Cranial Electrotherapy Stimulation on the Cognition, Anxiety, Depression and Sleep Quality of Chronic Psychiatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Depression Disorders
Keywords: Cranial Electrotherapy Stimulation
Chronic Psychiatric Patients
Lead sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 1. Research background Residents of nursing homes are chronically ill patients who are placed in long-term homes. Studies have shown that most residents live alone and are prone to loneliness, loss, depression, and anxiety (Lapane et al., 2022). Cranial electrostimulation (CES) can improve anxiety, depression, and sleep, but there are few studies on the cognitive status of patients with chronic mental illness.
2. Research purpose This study uses cranial microcurrent stimulation (CES) to improve cognition, anxiety, depression, sleep and other conditions in patients with chronic mental illness, with the aim of improving their quality of life.
3. Screening criteria for respondents 3.1 Inclusion criteria (Those who meet the following criteria are suitable to participate in this study)

1. Chronic mental illness patients, 2. Mini-Mental State Examination (MMSE) ≥ 16 points, 3. Education level is junior high school graduates or above, 4. Appropriate oral expression ability, 5. Those who can complete the research consent form, 6. Those who are willing to participate in this study Exclusion conditions (If you have the following conditions, you cannot participate in this study)

1. Those with obvious risk of violence or suicide; 2. Those with cognitive impairment diagnosed with intellectual disability or autism 4. Research Methods

1. The study was conducted at the Psychiatric Center
2. A total of 92 people were admitted, and they were randomly grouped.
3. This study is a interventional study. Before the intervention, a questionnaire must be filled out, which takes about 30 minutes. Then CES is performed 5 times a week, each time for 40 minutes. After completion, the questionnaire must be filled out again. After 3 months of follow-up, another questionnaire test will be conducted.
4. Possible discomfort and treatment methods During the CES intervention, if you feel dizzy, skin allergies, ear discomfort, or any discomfort, the intervention will be stopped immediately and the medical team will evaluate and treat you.
5. Expected benefits of the study This study uses cranial electrostimulation (CES) to improve cognition, anxiety, depression, sleep and other conditions in patients with chronic mental illness, with the aim of improving their quality of life.

6 Matters that respondents should cooperate with during the research Express your true inner thoughts on the questionnaire content. 7 Confidentiality This study collects data through questionnaires. All identifiable data will be coded to ensure personal data security and case privacy.

8. Subsidies and Damages Respondents who complete the research data collection will receive a gift voucher worth approximately NT$300


Eligibility criteria: Inclusion Criteria:

* 1. Chronic mental illness patients, 2. Mini-Mental State Examination (MMSE) ≥ 16 points, 3. Education level is junior high school graduates or above, 4. Appropriate oral expression ability, 5. Those who can complete the research consent form, 6. Those who are willing to participate in this study

Exclusion Criteria:

* 1. Those with obvious risk of violence or suicide 2. People with cognitive impairment who have been diagnosed with mental retardation or autism

Primary outcomes:
measure: sleep
timeFrame: "From enrollment to the end of treatment at 12 weeks"
measure: Depression
timeFrame: "From enrollment to the end of treatment at 12weeks"
Secondary outcomes:
measure: cognition
timeFrame: "From enrollment to the end of treatment at 12 weeks"
measure: anxiety
timeFrame: "From enrollment to the end of treatment at 12 weeks"
Other outcomes:
Locations:
city: Nantou
country: Taiwan
facility: Tsaotun Psychiatric Center, MOHW
Study officials:
References: