Auricular Acupuncture as an add-on Treatment for Symptoms of Anxiety
NCT ID: NCT04654884
Last Updated: 2020-12-04
Study Results
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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UNKNOWN
NA
72 participants
INTERVENTIONAL
2020-01-02
2023-01-31
Brief Summary
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Acupuncture is a nonpharmacological treatment method based on complementary medicine, for which interest has increased over the last years. It has, to some extent, been introduced in the ordinary health care system. Auricular acupuncture (AA) is a branch of acupuncture where needles are inserted in different areas in the outer ears AA has been used to treat anxiety as well as vid depression and post-traumatic stress syndrome (PTSD) among veterans. A standardised insertion pattern, defined as the National Acupuncture Detoxification Association (NADA) protocol, is normally practised, and it has also been used to treat insomnia. Evaluations has shown that AA according to the NADA-protocol has a calming effect and seem to alleviate symptoms of anxiety, depression and to some extent, also sleeping difficulties. The aim of this study is to study and evaluate effects of AA as an add-on treatment to treatment as usual (TaU) within affective outpatient care for patients suffering from symptoms of anxiety and depression.
A prospective, non-inferiority randomised controlled study (RCT) with a number of (N=72) participants will be conducted to answer the study aims. A qualitative interview study will also be conducted to find out how the patients experience AA as an adjunctive therapy.
Detailed Description
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Acupuncture is a nonpharmacological treatment method based on complementary medicine, for which interest has increased over the last years. It has, to some extent, been introduced in the ordinary health care system. Auricular acupuncture (AA) is a branch of acupuncture where needles are inserted in different areas in the outer ears AA has been used to treat anxiety as well as vid depression and post-traumatic stress syndrome (PTSD) among veterans. A standardised insertion pattern, defined as the National Acupuncture Detoxification Association (NADA) protocol, is normally practised, and it has also been used to treat insomnia.
Evaluations has shown that AA according to the NADA-protocol has a calming effect and seem to alleviate symptoms of anxiety, depression and to some extent, also sleeping difficulties.
The aim of this study is to study and evaluate effects of AA as an add-on treatment to treatment as usual (TaU) within affective outpatient care.
regarding:
* Anxiety/depression: is the treatment symptom relieving?
* Does it change the participants' intake addictive drugs (i.e. benzodiazepines)?
* Sleep: Is there some improvement in any sleep disorders that are linked to the basic problem?
* Do the treatment effects persist 6 months after the treatment has ended?
A prospective, non-inferiority randomised controlled study (RCT) with a number of (N=72) participants will be conducted to answer the study aims. A qualitative interview study will also be conducted to find out how the patients experience AA as an adjunctive therapy.
The participants will be randomised in two groups. The participants in group 1 will receive AA as an adjunctive therapy to TaU (i.e. individual counseling therapy, psycho therapy, pharmacological therapy) during 8 weeks. The add-on treatment will be administered at the treatment sessions with their caregiver (i.e. registered nurse, psychologist, curator), and at each session the participants receive 5 sterile stainless needles in each outer ear. The needling is standardised according to the NADA-protocol (10). The needles will remain in the outer ears for approximately 45 minutes, and will be removed by the care giver. Group 2, the control group, will receive TaU and will, just like group 1, have a follow-up after 8 weeks.
During the trial 12-15 participants from the AA group will be recruited to participate in an interview study. Semistructured interviews will be conducted after the 8 weeks intervention has finished. The questions are aimed to find out how the participants experienced the AA as an add-on treatment, and if AA was helpful to reduce symptoms of anxiety and depression.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
The participants in group 1 will receive AA as an adjunctive therapy to TaU (i.e. individual counseling therapy, psycho therapy, pharmacological therapy) during 8 weeks.
Auricular acupuncture (AA)
The add-on treatment will be administered at the treatment sessions with their caregiver (i.e. registered nurse, psychologist, curator), and at each session the participants receive 5 sterile stainless needles in each outer ear. The needling is standardised according to the NADA-protocol. The needles will remain in the outer ears for approximately 45 minutes, and will be removed by the care giver.
Group 2
Group 2, the control group, will receive TaU and will, just like goup 1, have a follow-up after 8 weeks.
No interventions assigned to this group
Interventions
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Auricular acupuncture (AA)
The add-on treatment will be administered at the treatment sessions with their caregiver (i.e. registered nurse, psychologist, curator), and at each session the participants receive 5 sterile stainless needles in each outer ear. The needling is standardised according to the NADA-protocol. The needles will remain in the outer ears for approximately 45 minutes, and will be removed by the care giver.
Eligibility Criteria
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Inclusion Criteria
* diagnosis within the anxiety syndrome area (F. 41)
* post traumatic stress syndrome (PTSD) with mixed symptoms of anxiety and depression (F.309.28).
Exclusion Criteria
* increased risk for suicide
* intellectual impairment
* recent change- or start-up of pharmacological therapy
* pregnancy.
18 Years
75 Years
ALL
Yes
Sponsors
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Uppsala University Hospital
OTHER
Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Lena U Bergdahl, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University
Locations
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Uppsala University Hospital
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Lena Bergdahl
Role: primary
Other Identifiers
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2019-06078 B
Identifier Type: -
Identifier Source: org_study_id