Acupuncture for Anxiety and Depression

NCT ID: NCT06994351

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-18

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Anxiety and Depression Breast Cancer Survivor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Electroacupuncture

Intervention Type DEVICE

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 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.

Group Type SHAM_COMPARATOR

Sham electroacupuncture

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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;

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yuanjie Sun

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuanjie Sun

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Locations

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China Academy of Chinese Medical Sciences

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Yuanjie Sun

Role: CONTACT

+8618810337542

Shuai Gao

Role: CONTACT

+8613128205732

Facility Contacts

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Yuanjie Sun

Role: primary

86 18810337542

Other Identifiers

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2025-046-KY-01

Identifier Type: -

Identifier Source: org_study_id

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