Anxiety and DepressionNCT06994351
Acupuncture for Anxiety and Depression
A study testing Electroacupuncture in people with Anxiety and Depression and Breast Cancer Survivor, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The study aims to primarily investigate the effects and safety of acupuncture on anxiety and depression among patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Anxiety and Depression, Breast Cancer Survivor
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, aged 18 to 70 years old;
- Meeting the diagnostic criteria for breast cancer and at TMN I-III;
- Having completed specialized active treatment for at least one month;
- With an ECOG score of 0-2;
- Mild to moderate anxiety and/or depression;
- Voluntarily joining this study and signing the informed consent form. Exclusion criteria
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China Academy of Chinese Medical Sciences
Beijing
Yuanjie Sun, 86 18810337542, puzhisun@163.com
About this study
Official title: 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.
- Conditions
- Anxiety and Depression, Breast Cancer Survivor
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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 electroacupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture group | Experimental | 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. Receives: Device: Electroacupuncture |
| Sham electroacupuncture group | Sham comparator | 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. Receives: Device: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 8
Secondary outcomes (12)
The change from baseline in the HADS
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: weeks 8 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start18 May 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanjie Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Yuanjie Sun, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994351
- Sponsor's protocol ID
- 2025-046-KY-01
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupuncture on Anxiety and Depression of Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06994351
- Acronym / sponsor ID
- 2025-046-KY-01
- Conditions
- Anxiety and Depression, Breast Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 18 May 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to primarily investigate the effects and safety of acupuncture on anxiety and depression among patients with breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Device: ElectroacupunctureAcupoints: 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. |
| Sham electroacupuncture group | Sham comparator | Device: Sham electroacupunctureAcupoints: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female, aged 18 to 70 years old;
- Meeting the diagnostic criteria for breast cancer and at TMN I-III;
- Having completed specialized active treatment for at least one month;
- With an ECOG score of 0-2;
- Mild to moderate anxiety and/or depression;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureThe 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. | Device | Electroacupuncture group |
| Sham electroacupunctureThe 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. | Device | Sham electroacupuncture group |
Primary outcome
The change from baseline in the Hospital Anxiety and Depression Scale (HADS)
Time frame: week 8
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
12 secondary outcomes
The change from baseline in the HADS
Time frame: weeks 4, 12, 16 and 20
The change from baseline in the HADS-A and HADS-D
Time frame: 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
Time frame: weeks 4, 8, 12, 16 and 20
The change from baseline in the Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: weeks 4, 8, 12, 16 and 20
The change from baseline in the Patient Health Questionnaire - 9 (PHQ-9)
Time frame: weeks 4, 8, 12, 16 and 20
Change from baseline in Hamilton Depression Scale-14
Time frame: Week 4, 8, 12, 16, 20
Change from baseline in Hamilton Depression Scale-17
Time frame: 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)
Time frame: weeks 4,8, 12 and 20
The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF)
Time frame: weeks 4, 8, 12 and 20
The change from baseline in the brief fatigue inventory (BFI)
Time frame: weeks 4, 8, 12, and 20
The change from baseline in the Insomnia Severity Index (ISI)
Time frame: weeks 4, 8, 12 and 20
The proportion of responders per the Patient Global Index of Improvement (PGI-I)
Time frame: weeks 8 and 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuanjie Sun principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Anxiety and Depression and Breast Cancer Survivor, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanjie Sun (+8618810337542, puzhisun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in the Hospital Anxiety and Depression Scale (HADS) (time frame: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.