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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01324674
First received: February 21, 2011
Last updated: January 16, 2012
Last verified: March 2011
  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

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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:
  • Complementary Alternative Therapy
  • Flower remedy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324674

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

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 July 29, 2014