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

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).

Study Overview

• Status: Completed
• Conditions: Mental Disorders; Personal Well Being
• Intervention / Treatment: Other: Placebo group; Other: Bach´s Flower Remedy

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São José dos Campos, São Paulo, Brazil, 12244000
      • University of Vale do Paraiba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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: Complementary Alternative Therapy; Flower remedy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: UPECLIN HC FM Botucatu Unesp
• Collaborators: University of Sao Paulo; Universidade do Vale do Paraíba
• Investigators: 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)

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 21, 2011
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Estimate): January 18, 2012
• Last Update Submitted That Met QC Criteria: January 16, 2012
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Common Mental Disorder; Efficacy of Bach´s flower remedy; Spiritual well-being
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Disease; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: upeclin/HC/FMB-Unesp-50