Acupuncture for Anxiety and Depression

Not Applicable

Not yet recruiting

• Conditions: Anxiety and Depression; Breast Cancer Survivor

• Registration Number: NCT06994351
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

The study aims to primarily investigate the effects and safety of acupuncture on anxiety and depression among patients with breast cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-18
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change from baseline in the Hospital Anxiety and Depression Scale (HADS)	week 8	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Hamilton Depression Scale-14	Week 4, 8, 12, 16, 20	The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1959 and is a clinical tool used to assess anxiety symptoms. All items use a 5-point rating scale from 0 to 4, with a total score ranging from 0 to 56. The cut-off value is 14 points. Generally, a score of \>14 points indicates anxiety, \>29 points indicates severe anxiety, and the higher the score, the more severe the anxiety symptoms.
The change from baseline in the HADS	weeks 4, 12, 16 and 20	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
The change from baseline in the HADS-A and HADS-D	weeks 4, 8, 12, 16 and 20	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Proportion of participants with a total HADS score less than 15, an HADS-A score of less than or equal to 7, and an HADS-D score of less than or equal to 7	weeks 4, 8, 12, 16 and 20	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
The change from baseline in the Generalized Anxiety Disorder 7-item scale (GAD-7)	weeks 4, 8, 12, 16 and 20	The GAD-7 self-assessment scale can be used for the preliminary evaluation of generalized anxiety symptoms. A score of 0 - 4 indicates no anxiety symptoms, a score of 5 - 9 indicates mild anxiety, a score of 10 - 14 indicates moderate anxiety, and a score of 15 or higher indicates severe anxiety.
The change from baseline in the Patient Health Questionnaire - 9 (PHQ-9)	weeks 4, 8, 12, 16 and 20	The PHQ-9 scale is commonly used for screening depressive symptoms. This scale consists of nine items, evaluating depressive symptoms by asking how much of the time the individual has been bothered by each of the nine aspects over the past two weeks. The scoring interpretation is as follows: 0 - 4 points indicate no depressive symptoms, 5 - 9 points indicate mild depressive symptoms, 10 - 14 points indicate moderate depressive symptoms, 15 - 19 points indicate relatively severe depressive symptoms, and 20 - 27 points indicate severe depressive symptoms. It is generally considered that a PHQ-9 score of 10 or higher, or sometimes 8 or higher, is clinically significant.
Change from baseline in Hamilton Depression Scale-17	Week 4, 8, 12, 16, 20	The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1960 and is the most commonly used scale in clinical assessment of depressive states. All items are scored on a 5-point scale ranging from 0 to 4. The total score is 68. A score of 8-17 indicates mild depression, 18-24 indicates moderate depression, and a score of ≥25 indicates severe depression.
The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer(FACT-B)	weeks 4,8, 12 and 20	The FACT-B is a specific scale designed to measure the quality of life in breast cancer patients, with higher scores indicating worse quality of life.
The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF)	weeks 4, 8, 12 and 20	The FCRI-SF score ranges from 0 to 168, with higher scores indicating a higher level of fear of cancer recurrence among cancer patients.
The change from baseline in the brief fatigue inventory (BFI)	weeks 4, 8, 12, and 20	The BFI score ranges from 0 to 10, with higher scores indicating greater fatigue.
The change from baseline in the Insomnia Severity Index (ISI)	weeks 4, 8, 12 and 20	The ISI score ranges from 0 to 28, with higher scores indicating Insomnia Severity.
The proportion of responders per the Patient Global Index of Improvement (PGI-I)	weeks 8 and 20	The PGI-I evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "much better", "a little better", "no change", "a little worse", "much worse" or "very much worse".

Trial Locations

Locations (1)

China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China