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Clinical study of digital therapy in the treatment of hypertension patents with anxiety and/or depression

Transformation Research on the Application of Psychological Assessment and Early Warning System in Sino-Japanese Friendship Hospital in the Cooperative Management of Patients with Chinese and Western Medicine ——Clinical study of digital therapy in the treatment of hypertension patents with anxiety and/or depression

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065631
Enrollment
Unknown
Registered
2022-11-10
Start date
2022-11-20
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Hypertension with anxiety and/or depression

Interventions

The experimental group 2:digital therapy and conventional Western Medicine treatment.
The experimental group 1:Hypertension is routinely treated with Western medicine

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Understand the process of the trial, participate voluntarily and sign the informed consent; 2. meet the diagnostic criteria of Western medicine for hypertension; 3. meeting the diagnostic criteria for psychological anxiety and depression (evaluated by the "Psychological Assessment and Early Warning System of China-Japan Friendship Hospital"); 4. Between 18 and 65 years old. Those who met all the above criteria were included in this study.

Exclusion criteria

Exclusion criteria: 1.Patients with clearly proven secondary hypertension; 2.patients who are being treated for anti-anxiety, depression or other mental disorders; 3.with a definite diagnosis of malignancy or other diseases affecting the 5-year survival rate; 4.Patients with ACS within 3 months or who are expected to undergo PCI or CABG; 5.heart failure occurring within 3 months; 6.Uncontrolled diabetes mellitus (fasting blood glucose >11.1mmol/L); 7.Abnormal liver function, ALT, AST more than 2 times the upper limit of normal; 8.Renal damage, serum creatinine more than 133mmol/L; 9.Patients with severe chronic obstructive pulmonary disease; Poorly controlled bronchial asthma; 10.Atrial fibrillation, severe arrhythmia, grade ? or above atrioventricular block; 11.Stroke patients; 12.Pregnant or lactating women or those with pregnancy plans; 13.Participating in other clinical investigators. If it meets any of the above criteria, it is excluded. Those who met all the above criteria were included in this study.

Design outcomes

Primary

MeasureTime frame
Change in Anxiety and Depression scale scores from baseline after 12 weeks of treatment;

Secondary

MeasureTime frame
Change in home systolic blood pressure from baseline after 12 weeks of treatment;Achievement rate of office systolic blood pressure compared with baseline after 12 weeks of treatment;Changes in office diastolic blood pressure from baseline after 12 weeks of treatment;Change in home diastolic blood pressure from baseline after 12 weeks of treatment;Change in 24-hour ambulatory blood pressure from baseline after 12 weeks of treatment;Changes in Pittsburgh Sleep Quality Index scores before and after 12 weeks of treatment;Changes of emotion Regulation scale before and after 12 weeks of treatment;Changes in stress perception scale scores before and after 12 weeks of treatment;Changes of positive and negative emotion scale before and after 12 weeks of treatment;Changes in burnout assessment before and after 12 weeks of treatment;The incidence of composite endpoint events after 12 weeks;

Countries

China

Contacts

Public ContactXiaoxiang

China-Japan Friendship Hospital

zryhyyxx@163.com15810314217

Outcome results

None listed

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