Acupuncture for Anxiety and Depression

The Effects of Acupuncture on Anxiety and Depression of Patients With Breast Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Survivor; Anxiety and Depression
• Intervention / Treatment: Device: Electroacupuncture; Device: Sham electroacupuncture

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuanjie Sun; Phone Number: +8618810337542; Email: puzhisun@163.com
• Study Contact Backup: Name: Shuai Gao; Phone Number: +8613128205732; Email: gaoshuai980314@163.com

Study Locations

• China
  • Beijing, China
    • China Academy of Chinese Medical Sciences
    • Contact: Yuanjie Sun; Phone Number: 86 18810337542; Email: puzhisun@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Female, aged 18 to 70 years old;
2. Meeting the diagnostic criteria for breast cancer and at TMN I-III;
3. Having completed specialized active treatment for at least one month;
4. With an ECOG score of 0-2;
5. Mild to moderate anxiety and/or depression;
6. Voluntarily joining this study and signing the informed consent form. Exclusion criteria

(1) Starting to take or change the regimen of anti-anxiety and/or -depression disorder medication within one month before enrolment; (2) Received psychological intervention or physical therapy one month before enrolment or planning to use in the next 5 months; (3) With diagnosis of anxiety and/or depression disorder prior to the diagnosis of breast cancer; (4) Patients with suicidal tendencies, bipolar disorder and psychotic symptoms; (5) Patients with severe anxiety and/or depression； (6) Patients received acupuncture treatment within one month before enrolment; (7) Participating in other clinical studies on the treatment of anxiety and depression; (8) Combined with severe underlying diseases; (9) Patients with severe skin ulcers; (10) Pregnant or lactating patients; (11) Poor compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electroacupuncture group; Acupoints: Bai Hui acupoint, An Mian acupoint, Shang Yin Tang acupoint, Tai Yang acupoint, Tai Yang acupoint, Tian Shu acupoint, Zu San Li acupoint, Tai Chong acupoint, Shen Men acupoint.	Device: Electroacupuncture; The needles will be inserted to 15-40mm in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes during 10-minute maintenance in prone and supine position respectively. The electronic acupuncture apparatus will be connected to the bileteral Taiyang, Anmian and Baihui, with a continuous wave of 2 Hertz (Hz) and an electric current of 1-3 milliampere (mA). Participants receive acupuncture treatment three times a week in the first two weeks and twice a week in the last six weeks.
Sham Comparator: Sham electroacupuncture group; Acupoints: Bai Hui acupoint, An Mian acupoint, Shang Yin Tang acupoint, Tai Yang acupoint, Tai Yang acupoint, Tian Shu acupoint, Zu San Li acupoint, Tai Chong acupoint, Shen Men acupoint.	Device: Sham electroacupuncture; The needle will be inserted to 2-3mm in Bai Hui acupoint. For the remaining acupoints, needles will be inserted into the pad and reaching the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effect of the needle tip penetrating the skin. The electronic acupuncture apparatus will be connected to the Baihui acupoint, Shang Yin Tang acupoint, and bilateral Anmian acupoints, with a continuous wave of 2 Hertz (Hz) and an electric current of 0.1-0.3 mA. In about 30 seconds, the electric current will be turned down. Participants receive acupuncture treatment three times a week in the first two weeks and twice a week in the last six weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change from baseline in the HADS	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.	weeks 4, 12, 16 and 20
The change from baseline in the HADS-A and HADS-D	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.	weeks 4, 8, 12, 16 and 20
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	The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.	weeks 4, 8, 12, 16 and 20
The change from baseline in the Generalized Anxiety Disorder 7-item scale (GAD-7)	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.	weeks 4, 8, 12, 16 and 20
The change from baseline in the Patient Health Questionnaire - 9 (PHQ-9)	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.	weeks 4, 8, 12, 16 and 20
Change from baseline in Hamilton Depression Scale-14	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.	Week 4, 8, 12, 16, 20
Change from baseline in Hamilton Depression Scale-17	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.	Week 4, 8, 12, 16, 20
The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer(FACT-B)	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.	weeks 4,8, 12 and 20
The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF)	The FCRI-SF score ranges from 0 to 168, with higher scores indicating a higher level of fear of cancer recurrence among cancer patients.	weeks 4, 8, 12 and 20
The change from baseline in the brief fatigue inventory (BFI)	The BFI score ranges from 0 to 10, with higher scores indicating greater fatigue.	weeks 4, 8, 12, and 20
The change from baseline in the Insomnia Severity Index (ISI)	The ISI score ranges from 0 to 28, with higher scores indicating Insomnia Severity.	weeks 4, 8, 12 and 20
The proportion of responders per the Patient Global Index of Improvement (PGI-I)	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".	weeks 8 and 20

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectance assessment	Participants will be asked: How do you expect your anxiety and depression will be in 8 weeks?	baseline
Assessment of belief in acupuncture	Participants will be asked the question: Do you think your anxiety and depression may be helped by acupuncture?	baseline and week 8
Blinding assessment	Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 8 weeks?	week 8
Adherence assessment	Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence.	through study completion, an average of five months
Proportion of participants using rescue medicine.	The percentage of patients using other medications or therapies that may affect their anxiety and depression.	through study completion, an average of five months
Safety assessment	Adverse events and severe adverse events will be recorded in the case report form, whether related to interventions or not.	through study completion, an average of five months

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Yuanjie Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 18, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 18, 2025
• First Submitted That Met QC Criteria: May 25, 2025
• First Posted (Actual): May 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 25, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms by Site; Neoplasms; Behavioral Symptoms; Mood Disorders; Skin Diseases; Breast Diseases; Anxiety Disorders; Depression; Depressive Disorder; Breast Neoplasms
• Other Study ID Numbers: 2025-046-KY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Deidentified participant data and data dictionary will be available with publication until six months after publication.

Formal request should be sent to puzhisun@163.com with a methodologically sound proposal.

Researchers whose proposal has been approved will sign a data access agreement.

• IPD Sharing Time Frame: The data will be available with publication until until six months after publication.

IPD Sharing Access Criteria

Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved.

Researchers whose proposal has been approved will sign a data access agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No