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More info
You can access this
clinical trial
if you have
Mental Disorders or Personal Well Being
and you are
over 18
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

The Common Mental Disorders (CMD) refer to health states involving non-psychotic psychiatric symptoms. Part of this broad diagnostic category, symptoms such as difficulty concentrating, forgetfulness, insomnia, fatigue, irritability, feelings of worthlessness, somatic complaints, etc. The CMD has a big social impact, and its prevalence in the general population is 25% and graduate students in health care reaches 40%. The Bach´s Flower Remedies are considered a complementary therapy approved and recommended by World Health Organization and by the Brazilian Ministry of Health and in his theory it has great spiritual nature. In addition, international scientific research have suggested that the strengthening of spiritual well-being can help significantly and positively promoting mental health. This project aims to assess the relationship between treatment with Bach´s Flower Remedies and Spiritual well-being of people with Common Mental Disorders in undergraduate health students of a university located in São José dos Campos, state of São Paulo, Brazil. This research presents a quantitative and qualitative methodology, experimental clinical trial, triple blind. The treatment will take place with two groups of forty people, the group of treatment and the placebo´s. The trial will happen in six sessions at intervals of 30 days, totaling eight months of treatment. Statistical analysis will be used chi-square or Fisher exact test to study the association between the scale of spiritual well-being and the use of Bach Flowers for each time point (3 times). To compare the evolution of the results (scales) during the study will set a model for ordinal data with repeated measurements over time. For these statistical tests is assumed a significance level of 5% (p < 0.005).

Provided treatments

  • Other: Bach´s Flower Remedy
  • Other: Placebo group

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01324674. The sponsor of the trial is UPECLIN HC FM Botucatu Unesp and it is looking for 70 volunteers for the current phase.
Official trial title:
Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder