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A multicenter randomized controlled study of acupuncture intensive treatment for patients with generalized anxiety disorder with insomnia symptoms

A multicenter randomized controlled study of acupuncture intensive treatment for patients with generalized anxiety disorder with insomnia symptoms

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000826
Enrollment
Unknown
Registered
2024-12-15
Start date
2024-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anxiety disorder

Interventions

control group:Anti-anxiety medication
Anti-anxiety medication:Anti-anxiety medication+Acupuncture therapy

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Age 18 and above gender is not limited; (2) Currently meets the diagnostic criteria for generalized anxiety disorder of the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5); (3) Hamilton Anxiety Scale (HAMA) > 14 points (4) Current symptoms of insomnia Pittsburgh Sleep Quality Index (PSQI) scale total score > 10; (5) Hamilton Depression Scale (HAMD) =17 points; (6) no mental and intellectual abnormalities can understand the provisions of the scale and complete the assessment; (7) Agree to participate in the study and sign a written informed consent.

Exclusion criteria

Exclusion criteria: (1) complicated with more serious heart liver kidney and other major diseases; (2) Exclude anxiety disorders caused by other physical diseases (such as hyperthyroidism pheochromocytoma etc.); (3) Excluding other types of anxiety disorders (such as social anxiety disorder compulsive disorder post-traumatic stress disorder) schizophrenia spectrum and other psychiatric disorders bipolar disorder depression etc.; (4) Pregnant or lactating patients; (5) Those who have a history of drug abuse or addiction; (6) Observers who have taken sedative hypnotics or antipsychotics in the 2 weeks prior to the baseline visit or who have received other treatment for insomnia (such as cognitive behavioral therapy) in the 3 months prior to the baseline visit which may affect the outcome; (7) long-term night work or irregular work and rest; (8) Participate in other clinical medical trials and studies within the past one month; (9) other organic sleep problems such as apnea syndrome restless leg syndrome etc. (10) Contraindications for acupuncture treatment: for patients in pregnancy who are combined with other serious life-threatening underlying diseases the selected acupuncture point area has ulcers abscesses skin infections limb mutilations and other conditions that cannot be acupuncture treatment.

Design outcomes

Primary

MeasureTime frame
HAMA;

Secondary

MeasureTime frame
ISI;PSQI;Sleep quality;

Countries

China

Contacts

Public ContactChengmei Mei

Shanghai Mental Health Center

yuanchengmei@yeah.net+86 138 1813 2592

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026