Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder
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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).
| Condition | Intervention | Phase |
|---|---|---|
|
Mental Disorders Personal Well Being |
Other: Bach´s Flower Remedy Other: Placebo group |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder |
- Self-Reporting Questionnaire (SRQ-20) [ 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. ] [ Designated as safety issue: Yes ]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).
- Spiritual Index of Well-Being Scale (SIWBS) [ 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 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 70 |
| Study Start Date: | February 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo group
Is the group of subjects that will take placebo
|
Other: Placebo group
The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months
Other Name: Complementary Alternative Therapy
|
|
Experimental: experimental 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.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- People over 18 years old
- People who have read and agreed to participate by signing an informed consent
- People who obtain scores equal to or above 8 for women and equal to or above 6 for men in SRQ - 20
- People who does not ingest medication
- People who does not use any type of complementary therapy and integrative such as Herbal Medicine, Aromatherapy, Homeopathy, Flower Essences, Reiki, acupuncture, etc.
Exclusion Criteria:
- Not meet the assumptions of the inclusion criteria
Contacts and Locations| Brazil | |
| University of Vale do Paraíba | |
| São José dos Campos, São Paulo, Brazil, 12244000 | |
| Study Chair: | Ivan A Guerrini, PhD | Medical School of São Paulo State University (UNESP) |
| Study Chair: | Ruth Turrini, PhD | Nursing School of University of São Paulo - (EEUSP) |
More Information
No publications provided
| Responsible Party: | Ana Paula Corrêa Castello Branco Nappi Arruda, MSc, Doctoral degree, UPECLIN HC FM Botucatu Unesp |
| ClinicalTrials.gov Identifier: | NCT01324674 History of Changes |
| Other Study ID Numbers: | upeclin/HC/FMB-Unesp-50 |
| Study First Received: | February 21, 2011 |
| Last Updated: | January 16, 2012 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by UPECLIN HC FM Botucatu Unesp:
|
Common Mental Disorder Efficacy of Bach´s flower remedy Spiritual well-being |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 19, 2013