Acupuncture for Anxiety and Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
About this trial
The study aims to primarily investigate the effects and safety of acupuncture on anxiety and depression among patients with breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Electroacupuncture
DeviceThe 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
DeviceThe 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Electroacupuncture groupExperimental treatment 1 intervention
Group B: Sham electroacupuncture groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
week 8Secondary outcomes
1
The change from baseline in the HADS
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
Time frame
weeks 4, 12, 16 and 202
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.
Time frame
weeks 4, 8, 12, 16 and 203
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.
Time frame
weeks 4, 8, 12, 16 and 204
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.
Time frame
weeks 4, 8, 12, 16 and 20Other outcomes
1
Expectance assessment
Participants will be asked: How do you expect your anxiety and depression will be in 8 weeks?
Time frame
baseline2
Assessment of belief in acupuncture
Participants will be asked the question: Do you think your anxiety and depression may be helped by acupuncture?
Time frame
baseline and week 83
Blinding assessment
Participants will be asked the question: Do you think you have received traditional electroacupuncture in the past 8 weeks?
Time frame
week 84
Adherence assessment
Adherence will be assessed via counting treatment sessions. Those who complete over 80% treatment sessions will be defined as of good adherence.
Time frame
through study completion, an average of five monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: