A Phase 2 interventional study of Bach´s Flower Remedy and Placebo group in Mental Disorders and Personal Well Being, sponsored by UPECLIN HC FM Botucatu Unesp. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-18.
Sponsored by UPECLIN HC FM Botucatu Unesp · Phase 2, Interventional, and Treatment
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).
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 70 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →UPECLIN HC FM Botucatu Unesp is the lead sponsor of 63 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Is the group of subjects that will take placebo
Other: Placebo group
Is the group of subjects that will take Bach´s Flower remedies
Other: Bach´s Flower Remedy
The subjects will have 4 drops 4 times per day, for approximately 8 months.
Also known as: Complementary Alternative Therapy, Flower remedy
The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months
Also known as: Complementary Alternative Therapy
Self-Reporting Questionnaire (SRQ-20)
The Self-Reporting Questionnaire was developed by Harding et al. (1980), from four other instruments used for screening for possible mental disorders. The development of this instrument was coordinated by World Health Organization (WHO) and aimed to reach a possible instrument to identify cases in primary care services and community, especially in developing countries with lack of services and professionals. The intention of the WHO was to identify cases from the instrument and to encourage planners to provide services and mental health care to the needy population (WHO, 1994).
Time frame: (8 months) In 3 times: the first one in the first visit, the second one in the third visit and the last one in the sixth visit.
Spiritual Index of Well-Being Scale (SIWBS)
This instrument, translated and validated into Portuguese from the Index of Spiritual Well-Being Scale (SIWBS) is a research tool that aims to assess the influence of spiritual values in the spiritual welfare of individuals.
Time frame: (8 months) 3 times after the intervention: the first one in the first visit, the second one in the third visit and the last one in the sixth visit
This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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UPECLIN HC FM Botucatu Unesp