Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder

Mental Disorders Clinical Trial

Official title:

Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324674
• Other study ID #: upeclin/HC/FMB-Unesp-50
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2011
• Last updated: January 16, 2012
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2011
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Personal Well Being
• Psychotic Disorders

Intervention

Other:
• Bach´s Flower Remedy
The subjects will have 4 drops 4 times per day, for approximately 8 months.
• Placebo group
The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months

Locations

Country	Name	City	State
Brazil	University of Vale do Paraíba	São José dos Campos	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp	Universidade do Vale do Paraíba, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	(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	Yes