Generalized Anxiety Disorder with comorbid insomnia
Conditions
Interventions
Liver-regulating and spirit-modulating acupuncture and pills for soothing the liver relieving depression and calming the spirit group:Treatment with acupuncture for soothing the liver and regulating
Liver-regulating and spirit-modulating acupuncture and comforting pills group:Liver-soothing and spirit-regulating acupuncture combined with 8g of placebo pills per tid for treatment
Comforting acupuncture and liver-soothing depression-relieving and calming pills group:Placebo acupuncture combined with 8g /tid of Shugan Jieyu Anshen Pills for treatment
Anti-anxiety drug group:Venlafaxine hydrochloride sustained-release capsules 75mg/qd for treatment
Liver-regulating and spirit-modulating acupuncture group:The acupuncture treatment for soothing the liver and regulating the spirit was administered three times a week for a total of 12 weeks, with a
Comforting acupuncture group:Placebo injections are administered three times a week for a total of 36 treatments over a period of 12 weeks (a patient is considered an effective case if they receive 29
Healthy group:No clinical intervention was performed, and only the scale and MRI were performed for evaluation
Sponsors
Shenzhen Bao'an Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) According to the "Chinese Classification and Diagnostic Criteria of Mental Disorders, 3rd Edition (CCMD-3)", the patient meets the diagnostic criteria for generalized anxiety disorder during a depressive episode, and also meets the diagnostic criteria for insomnia, including both A and B criteria. The patient also meets the diagnostic criteria for generalized anxiety disorder (GAD) in the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)". (2) The patient meets the diagnostic criteria for depression and insomnia in the "Standards for Diagnosis and Therapeutic Effect of Traditional Chinese Medicine Diseases and Syndromes" (ZY/T001.1-001.9-94, issued by the State Administration of Traditional Chinese Medicine on June 28, 1994), specifically the syndrome types of liver qi stagnation and heart-kidney disharmony. The patient also meets the diagnostic criteria for chronic insomnia disorder in the "International Classification of Sleep Disorders, Third Edition (ICSD-3)" or DSM-5, characterized by difficulty falling asleep, maintaining sleep, or early awakening, occurring on at least three nights per week for at least three months. (3) The patient is aged 18 to 60 years old, right-handed, and has at least a junior high school education. (4) The patient has a score of 14 or higher on the 14-item Hamilton Anxiety Scale (HAMA). (5) The patient has a total score of 7 or higher on the Pittsburgh Sleep Quality Index (PSQI). (6) The patient has a disease duration of at least 6 months and has not received anti-anxiety medication, traditional Chinese medicine, physical or psychological treatment in the past 6 weeks. (7) The patient has a total score of 7 or lower on the Hamilton Depression Rating Scale (HAMD), and a mandatory score of 0 on the item for suicidal ideation. (8) The severity of insomnia is confirmed through a baseline full-night polysomnography (PSG), meeting at least one of the following criteria: sleep onset latency (SOL) > 30 minutes, wake after sleep onset (WASO) > 30 minutes, or sleep efficiency (SE) < 85%. (9) The patient has sufficient cognitive ability to understand the content of the scales and sign the informed consent form, and voluntarily participates in this study. Only patients who meet all the inclusion criteria above can be included in this study. The research team invited specialized doctors from the Department of Psychosomatic Medicine to provide systematic training on the inclusion and exclusion criteria and clinical scales to the researchers. The Hamilton Anxiety Scale and Hamilton Depression Scale are scored by specialized doctors.
Exclusion criteria
Exclusion criteria: (1) A score of more than 7 on the 17-item Hamilton Depression Rating Scale (HAMD); (2) Anxiety attacks secondary to other mental or physical disorders and those with severe psychotic symptoms; (3) A previous diagnosis of intellectual disability, schizophrenia, bipolar disorder, substance abuse (such as alcohol dependence), or other mental disorders; (4) A history of epilepsy or a strong positive family history of epilepsy, brain organic diseases, or severe physical diseases; (5) Those who have been taking anti-anxiety or anti-depression drugs within 6 weeks (including 6 weeks); (6) Pregnant, planning to become pregnant, or breastfeeding; (7) Those with concurrent skin lesions or skin diseases, severe diabetes, tumors, or severe organ dysfunction or serious internal diseases such as liver, kidney, cardiovascular, endocrine, respiratory system, hyperthyroidism, and hematological system diseases; (8) Those with contraindications for MRI such as pacemakers, heart stents, claustrophobia, or recent hair dyeing. (Note: Those who meet this criterion will not be included in the neuroimaging mechanism subgroup but can remain in the main clinical trial cohort) Those with structural brain abnormalities before enrollment, such as intracranial space-occupying lesions, brain malformations, severe stroke (affecting brain structure), or other central or peripheral nerve diseases. (Note: Those who meet this criterion will not be included in the neuroimaging mechanism subgroup but can remain in the main clinical trial cohort) (9) Those with other organic sleep disorders, such as restless legs syndrome (RLS). (10) Those diagnosed with obstructive sleep apnea (OSA) based on baseline polysomnography (PSG), with an apnea-hypopnea index (AHI) > 5 times per hour. (11) Those with periodic limb movement disorder (PLMD), with a periodic limb movement sleep index (PLMSI) > 15 times per hour. (12) Those with evidence of paradoxical insomnia (poor perception of sleep state), with baseline PSG parameters not reaching the threshold for insomnia severity: sleep onset latency (SOL) = 30 minutes, wake after sleep onset (WASO) = 30 minutes, or sleep efficiency (SE) = 85%. (13) Those with irregular sleep patterns or currently engaged in long-term night shift work. Any individual meeting any of the above criteria will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale;Pittsburgh sleep quality index;polysomnography;Consensus Sleep Diary; | — |
Secondary
| Measure | Time frame |
|---|---|
| generalized anxiety disorder-7;Insomnia Severity Index;Electrocardiogram;5-hydroxy-trytamine;Norepinephrine;Dopamine;C-reactive protein;Blinding effectiveness (assessed using Bang's Blinding Index);Self-Rating Anxiety Scale;Interleukin-6 (IL-6);Tumor Necrosis Factor-alpha (TNF-a); | — |
Countries
People's Republic of China
Contacts
Public ContactRundong Tang
Shenzhen Bao'an Chinese Medicine Hospital
Outcome results
None listed