To Study the Effect of SMART-CAI on Generalized Anxiety Disorder with Insomnia

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2022000014

Enrollment

Unknown

Registered

2022-06-13

Start date

2023-03-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

generalized anxiety disorder

Interventions

control group:progressive relaxation training

experimental group:SMART-CAI of Traditonal Chinese Medicine

Eligibility

Sex/Gender

All

Age

12 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age between 12 to 70 2.Diagnosed with generalized anxiety disorder with insomnia 3.GAD-7=14 4.ISI>7,<22 5.Educational level is above elementary school.

Exclusion criteria

Exclusion criteria: 1. Pregnant woman 2.Severe anxiety or severe insomnia 3. With other severe diseases or other unstable diseases 4. Using other medicine or therapy to treat anxiety or insomnia during the intervention 5.Alcoholic 6.People who is without guardian or can not adhere to treatment.

Design outcomes

Primary

Measure	Time frame
Total score of HAMA;Total score of PSS-10;Total score of PSQI;Physical Stress Index of HRV;	—

Secondary

Measure	Time frame
Each factor's score of PSS-10;Total score of CD-RISC;Changes of signal response in Hemoglobin levels of fNIRS;Total score of ISI;Total score of GAD-7;Each factor's score of PSS-10;Each factor's score of PSQI;	—

Countries

China

Contacts

Public ContactWang Fang

vision_wf@126.com13466337140

Outcome results

None listed

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