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

NCT01324674 | Completed Phase 2 DMC

• 1 other identifier: upeclin/HC/FMB-Unesp-50
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Mental Disorders; Personal Well Being

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Spiritual Index of Well-Being Scale (SIWBS)

  (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

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Is the group of subjects that will take placebo

Other: Placebo group

experimental group

EXPERIMENTAL

Is the group of subjects that will take Bach´s Flower remedies

Other: Bach´s Flower Remedy

Interventions

Bach´s Flower Remedy OTHER

The subjects will have 4 drops 4 times per day, for approximately 8 months.

Also known as: Complementary Alternative Therapy, Flower remedy

experimental group

Placebo group OTHER

The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months

Also known as: Complementary Alternative Therapy

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• University of Sao Paulo: collaborator
• Universidade do Vale do Paraíba: collaborator

Study Sites (1)

University of Vale do Paraíba

São José dos Campos, São Paulo, 12244000, Brazil

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Complementary Therapies; Flower Essences

Intervention Hierarchy (Ancestors)

Therapeutics; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, Doctoral degree

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: March 29, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2011-03

Locations

BR (1)