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

• ClinicalTrials.gov Identifier: NCT01324674
• Recruitment Status: Completed
• First Posted: March 29, 2011
• Last Update Posted: January 18, 2012
• Sponsor: UPECLIN HC FM Botucatu Unesp
• Collaborators: University of Sao Paulo; Universidade do Vale do Paraíba
• Information provided by (Responsible Party): Ana Paula Corrêa Castello Branco Nappi Arruda, UPECLIN HC FM Botucatu Unesp

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Mental Disorders; Personal Well Being	Other: Bach´s Flower Remedy; Other: Placebo group	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder
• Study Start Date: February 2011
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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 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: Complementary Alternative Therapy; Flower remedy

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   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).

Secondary Outcome Measures :

1. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Locations

Brazil

University of Vale do Paraíba

São José dos Campos, São Paulo, Brazil, 12244000

Sponsors and Collaborators

UPECLIN HC FM Botucatu Unesp

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)

More Information

• Responsible Party: Ana Paula Corrêa Castello Branco Nappi Arruda, MSc, Doctoral degree, UPECLIN HC FM Botucatu Unesp
• ClinicalTrials.gov Identifier: NCT01324674
• Other Study ID Numbers: upeclin/HC/FMB-Unesp-50
• First Posted: March 29, 2011
• Last Update Posted: January 18, 2012
• Last Verified: March 2011

Keywords provided by Ana Paula Corrêa Castello Branco Nappi Arruda, UPECLIN HC FM Botucatu Unesp:

Common Mental Disorder; Efficacy of Bach´s flower remedy; Spiritual well-being

Additional relevant MeSH terms:

Disease; Mental Disorders; Psychotic Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders