Generalized Anxiety
Conditions
Interventions
This is a randomized controlled clinical trial with two arms, open label, including a total sample of 60 women randomly allocated into two equal groups, 30 participants in the Acupuncture group and 30
F04.754.137.350
Sponsors
Organização Mogiana de Educação e Cultura Sociedade Simples Ltda
Organização Mogiana de Educação e Cultura Sociedade Simples Ltda
Eligibility
Sex/Gender
Female
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: Women; aged between 18 and 49 years; with a clinical diagnosis of anxiety according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); presenting moderate to severe symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A)
Exclusion criteria
Exclusion criteria: Pregnant women; women using anxiolytic or antidepressant medication; those undergoing other forms of psychotherapy or acupuncture; women with severe psychiatric or neurological disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: It is expected to find a significant reduction in anxiety symptoms after eight weeks of intervention in both the acupuncture group and the cognitive-behavioral psychotherapy group. This outcome was verified by the Hamilton Anxiety Rating Scale (HAM-A), applied at baseline and after the eight-week treatment protocol. The sample size (60 participants, 30 per group) was calculated based on an estimated prevalence of 19.9% of anxiety disorders, a 95% confidence level, and a 5% sampling error;Found outcome 1: A significant reduction in anxiety symptoms was observed in both groups, measured by the Hamilton Anxiety Rating Scale (HAM-A). In the acupuncture group, the mean score decreased from 37.1 ± 7.94 to 15.4 ± 6.94. In the cognitive-behavioral psychotherapy group, the mean score decreased from 37.0 ± 8.58 to 18.0 ± 7.8. Both reductions were statistically significant (p < 0.001) | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: It was expected to observe improvement in both the psychic and somatic dimensions of anxiety, assessed separately using the Hamilton Anxiety Rating Scale (HAM-A). The secondary aim was to verify whether any group would present more expressive improvements;Outcome found 2: Psychic improvements were similar between groups (p = 0.171). However, the acupuncture group showed a more significant reduction in somatic symptoms compared to the psychotherapy group (median 11 [8–12.8] vs. 7.5 [5–11], p = 0.047) | — |
Countries
Brazil
Contacts
Public ContactGuilherme Lordelo
Universidade de Mogi das Cruzes
Outcome results
None listed