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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Mental Disorders Personal Well Being

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo group

Is the group of subjects that will take placebo

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type OTHER

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

experimental group

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

Group Type EXPERIMENTAL

Bach´s Flower Remedy

Intervention Type OTHER

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

Interventions

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Bach´s Flower Remedy

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

Intervention Type OTHER

Placebo group

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

Intervention Type OTHER

Other Intervention Names

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Complementary Alternative Therapy Flower remedy Complementary Alternative Therapy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No