Anxiety, Depression, Depressive Symptoms, Insomnia, Quality of Life
Conditions
Keywords
depression, auricular acupuncture, clinical trial, anxiety, insomnia, quality of life
Brief summary
Participants with moderate depressive symptoms measured by PHQ-9 will be randomized to receive auricular acupuncture. The triple blinded procedure will be conducted in 12 sessions (6 weeks). The primary outcome is the response to the treatment 3 months after inclusion.
Detailed description
Depression, often under-diagnosed and under-treated, is the leading cause of disability worldwide and contributes significantly to the global burden of diseases, with university students being a major risk group. There is a growing demand for non-pharmacological treatments for depression. In this sense, auricular acupuncture is considered a simple, low cost technique, well accepted by patients. The Unified Health System (Sistema Único de Saúde -SUS) incorporated this practice in 2006, but there is a lack of studies evaluating its efficacy and safety. The main objective of this study is to evaluate the efficacy of auricular acupuncture to reduce depressive symptoms in comparison with usual care and non-specific auricular acupuncture. This is a randomized clinical trial, blinded to the evaluator, participant and statistician. The study sample will be composed of 280 university students, divided equally into two groups: Experimental group - GE (auricular acupuncture) and Control group - GC (non-specific auricular acupuncture). The GE and GC participants will be submitted to 12 sessions of auricular acupuncture, 2 times a week. The primary outcome of the study will be the proportion of participants who present improvement of 50% or more in their symptoms, evaluated by the PHQ-9, three months after inclusion. The secondary outcomes will be: improvement of 50% or more in their symptoms, after six months; quality of life (SF-36), change in the use of antidepressant medication, events and adverse effects, levels of Brain-derived neurotrophic factor (BDNF), Interleukin 1β, Interleukin-6 and TNF-α in blood plasma. The data will be analyzed aiming at treating according to the principles of CONSORT.
Interventions
DEVICEAuricular Acupuncture
Aplication of semi-permanents needls in the ear by an experient and specialized professional using tradicional chinese maps and a specific device to find acupuncture points. There is a gap of one day minimum between sessions and two non-consecutive absences are allowed.
Sponsors
University of Sao Paulo
Universidade do Sul de Santa Catarina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 50 years old * PHQ-9 score between 10 and 19 (moderate depression) * Availability for sessions
Exclusion criteria
Use complementary and integrative practices at the last 3 months; Suicidal risk evaluated by question number 9 in the PHQ-9 Severe depression score in the PHQ-9 Prior use of auricular acupuncture Pregnancy Menopause Tape and metal allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease of Depression Symptoms | 3 months | The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 3 months after study inclusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BDNF, Interleukin, TNF | 6 weeks | Levels of BDNF, Interleukin 1β, Interleukin-6 and TNF-α, evaluated at the beginning and end of auricular acupuncture applications (end of the sixth week of application) |
| Decrease of Depression Symptoms | 6 weeks | The efficacy of auricular acupuncture to reduce depression symptoms compared to non-specific auricular acupuncture 6 weeks after study inclusion. |
| Decrease of Insomnia | 3 months | The efficacy of auricular acupuncture to reduce insomnia compared to non-specific auricular acupuncture 3 months after study inclusion. |
| Decrease of Anxiety Symptoms | 3 months | The efficacy of auricular acupuncture to reduce anxiety symptoms compared to non-specific auricular acupuncture 3 months after study inclusion. |
| Increase of Quality of Life | 3 months | The efficacy of auricular acupuncture to increase quality of life compared to non-specific auricular acupuncture 3 months after study inclusion. |
Countries
Brazil
Contacts
Primary ContactDaniel MO Rodrigues, MSc
Backup ContactAlexandre F Cury, PhD
Outcome results
None listed