Auricular Acupuncture as an add-on Treatment for Symptoms of Anxiety

NCT04654884 | Unknown

• 1 other identifier: 2019-06078 B
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Post Traumatic Stress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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 (1)

• The Insomnia Severity Index

  Change from Baseline to end of treatment (8 weeks after baseline measurement) and change from baseline to 6 months after the end of treatment.

Study Arms (2)

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.

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.

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Combat Disorders

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Lena U Bergdahl, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Bergdahl, PhD

CONTACT

+46768474102; lena.bergdahl@neuro.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: December 4, 2020
• Study Start: January 2, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: December 4, 2020

Record last verified: 2020-12

Locations

SE (1)