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Sponsor study identifier
interventional
70
1 country
1
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 21, 2011
Actual (reported)March 29, 2011
Actual (reported)December 2011
Actual (reported)December 2011
Actual (reported)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).
(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)
(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
Is the group of subjects that will take placebo
Is the group of subjects that will take Bach´s Flower remedies
The subjects will have 4 drops 4 times per day, for approximately 8 months.
The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months
University of Vale do Paraíba
São José dos Campos, São Paulo, 12244000, Brazil
Ivan A Guerrini, PhD
Medical School of São Paulo State University (UNESP)
Ruth Turrini, PhD
Nursing School of University of São Paulo - (EEUSP)
70 participants (actual enrollment reported by the registry).
First Submitted
February 21, 2011
First Posted
March 29, 2011
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
January 18, 2012
Record last verified: 2011-03
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Source: ClinicalTrials.gov.
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