Anxiety DisordersNCT04654884
Auricular Acupuncture as an add-on Treatment for Symptoms of Anxiety
A study testing Auricular acupuncture (AA) in people with Anxiety Disorders and Post Traumatic Stress Syndrome, run by Uppsala University at 1 site in Sweden.
Trial summary
Mental illness is very common in todays' society, and it is the most common cause for sick leave in Sweden. Affective diseases, such as different states of anxiety and depression, are the two most common conditions of mental illness that has been reported by different workplaces in Sweden. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Post Traumatic Stress Syndrome
- What is being tested?
- Auricular acupuncture (AA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- 2 Jan 2020to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women aged 18 - 75
- diagnosis within the anxiety syndrome area (F. 41)
- post traumatic stress syndrome (PTSD) with mixed symptoms of anxiety and depression (F.309.28).
Who cannot join
- psychotic symptoms
- increased risk for suicide
- intellectual impairment
- recent change- or start-up of pharmacological therapy
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, 75185
Lena Bergdahl, lena.bergdahl@neuro.uu.se
Lena Bergdahl, PhD
About this study
Official title: Auricular Acupuncture as an add-on Treatment for Symptoms of Anxiety Within Affective Out-patient Care
Mental illness is very common in todays' society, and it is the most common cause for sick leave in Sweden. Affective diseases, such as different states of anxiety and depression, are the two most common conditions of mental illness that has been reported by different workplaces in Sweden. Pharmacological treatment of anxiety using benzodiazepines, tends to be long, and it may lead to substance dependence, as well as severe side effects such as increased anxiety levels, cognitive impact and psychomotor effects. The Swedish Council on Health Technology Assessment (SBU) have identified that there are scientific knowledge gaps that needs to be filled regarding the mental illness care, such as anxiety. There is a need for evaluations of non-pharmacological, complementary treatments as well as research with a high methodological quality.
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.
Read the detailed description
Mental illness is very common in todays' society, and it is the most common cause for sick leave in Sweden. Affective diseases, such as different states of anxiety and depression, are the two most common conditions of mental illness that has been reported by different workplaces in Sweden. Pharmacological treatment of anxiety using benzodiazepines, tends to be long, and it may lead to substance dependence, as well as severe side effects such as increased anxiety levels, cognitive impact and psychomotor effects. The Swedish Council on Health Technology Assessment (SBU) have identified that there are scientific knowledge gaps that needs to be filled regarding the mental illness care, such as anxiety. There is a need for evaluations of non-pharmacological, complementary treatments as well as research with a high methodological quality.
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
- Anxiety Disorders, Post Traumatic Stress Syndrome
- Being tested
- Auricular acupuncture (AA)
- Medical subject headings
- Anxiety Disorders, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupuncture (AA)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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. Receives: Other: Auricular acupuncture (AA) |
| Group 2 | No intervention | Group 2, the control group, will receive TaU and will, just like goup 1, have a follow-up after 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory
A self-assessment scale to measure the prevalence of anxiety, worry and anxiety. Range of score is 20 to 80 in each subtest, the higher score indicate greater anxiety. The cutoff point is 39-40. STAI is the study's primary outcome measure.
Measured: Change from Baseline to end of treatment (8 weeks after baseline measurement) and change from baseline to 6 months after the end of treatment.
Secondary outcomes (1)
The Patient Health Questionnaire
A concise self-assessment scale for screening for actual depression and measuring the current symptom level of depression. Minimum score is 0 and maximum score is 27. The higher score indicate more severe depression. The cutoff points are 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe levels of depressive symptoms.
Measured: Change from Baseline to end of treatment (8 weeks after baseline measurement) and change from baseline to 6 months after the end of treatment..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start2 Jan 2020
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomisation into two groups. Group 1 will receive AA as an adjunctive therapy to TaU (i.e. individual counseling therapy, psycho therapy, pharmacological therapy)Group 2, the control group, will receive TaU.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Lena U Bergdahl, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654884
- Sponsor's protocol ID
- 2019-06078 B
- Other IDs
- 2019
- Status last verified
- Dec 2020
- First submitted
- 3 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture as an add-on Treatment for Symptoms of Anxiety Within Affective Out-patient Care
- ClinicalTrials.gov ID
- NCT04654884
- Acronym / sponsor ID
- 2019-06078 B
- Conditions
- Anxiety Disorders, Post Traumatic Stress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 4 Dec 2020 (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.
Mental illness is very common in todays' society, and it is the most common cause for sick leave in Sweden. Affective diseases, such as different states of anxiety and depression, are the two most common conditions of mental illness that has been reported by different workplaces in Sweden. Pharmacological treatment of anxiety using benzodiazepines, tends to be long, and it may lead to substance dependence, as well as severe side effects such as increased anxiety levels, cognitive impact and psychomotor effects. The Swedish Council on Health Technology Assessment (SBU) have identified that there are scientific knowledge gaps that needs to be filled regarding the mental illness care, such as anxiety. There is a need for evaluations of non-pharmacological, complementary treatments as well as research with a high methodological quality.
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
Mental illness is very common in todays' society, and it is the most common cause for sick leave in Sweden. Affective diseases, such as different states of anxiety and depression, are the two most common conditions of mental illness that has been reported by different workplaces in Sweden. Pharmacological treatment of anxiety using benzodiazepines, tends to be long, and it may lead to substance dependence, as well as severe side effects such as increased anxiety levels, cognitive impact and psychomotor effects. The Swedish Council on Health Technology Assessment (SBU) have identified that there are scientific knowledge gaps that needs to be filled regarding the mental illness care, such as anxiety. There is a need for evaluations of non-pharmacological, complementary treatments as well as research with a high methodological quality.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomisation into two groups. Group 1 will receive AA as an adjunctive therapy to TaU (i.e. individual counseling therapy, psycho therapy, pharmacological therapy)Group 2, the control group, will receive TaU.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Auricular acupuncture (AA)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. |
| Group 2 | No intervention | –Group 2, the control group, will receive TaU and will, just like goup 1, have a follow-up after 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women aged 18 - 75
- diagnosis within the anxiety syndrome area (F. 41)
- post traumatic stress syndrome (PTSD) with mixed symptoms of anxiety and depression (F.309.28).
Key exclusion criteria (5 listed)
- psychotic symptoms
- increased risk for suicide
- intellectual impairment
- recent change- or start-up of pharmacological therapy
- pregnancy.
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 |
|---|---|---|
| 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. | Other | Group 1 |
Primary outcome
The State-Trait Anxiety Inventory
Time frame: Change from Baseline to end of treatment (8 weeks after baseline measurement) and change from baseline to 6 months after the end of treatment.
A self-assessment scale to measure the prevalence of anxiety, worry and anxiety. Range of score is 20 to 80 in each subtest, the higher score indicate greater anxiety. The cutoff point is 39-40. STAI is the study's primary outcome measure.
1 secondary outcome
The Patient Health Questionnaire
Time frame: Change from Baseline to end of treatment (8 weeks after baseline measurement) and change from baseline to 6 months after the end of treatment..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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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. This study is not recruiting at the moment.
Lena U Bergdahl, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture (AA) in people with Anxiety Disorders and Post Traumatic Stress Syndrome, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Dec 2020. 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 Sweden. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lena Bergdahl, PhD (+46768474102, lena.bergdahl@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The State-Trait Anxiety Inventory (time frame: Change from Baseline to end of treatment (8 weeks after baseline measurement) and change from baseline to 6 months after the end of treatment.). 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 4 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.