Clinical trial NCT04654884: Auricular Acupuncture as an add-on Treatment for Symptoms of Anxiety
Official title: Auricular Acupuncture as an add-on Treatment for Symptoms of Anxiety Within Affective Out-patient Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Post Traumatic Stress Syndrome
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
First posted: 2020-12-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria

* 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).

Exclusion Criteria

* psychotic symptoms
* increased risk for suicide
* intellectual impairment
* recent change- or start-up of pharmacological therapy
* pregnancy.

Primary outcomes:
measure: The State-Trait Anxiety Inventory
timeFrame: 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:
measure: The Patient Health Questionnaire
timeFrame: Change from Baseline to end of treatment (8 weeks after baseline measurement) and change from baseline to 6 months after the end of treatment..
Other outcomes:
measure: The Insomnia Severity Index
timeFrame: Change from Baseline to end of treatment (8 weeks after baseline measurement) and change from baseline to 6 months after the end of treatment.
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Lena U Bergdahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: