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

UPECLIN HC FM Botucatu Unesp

Status and phase: Completed; Phase 2

Conditions: Personal Well Being; Mental Disorders

Treatments: Other: Placebo group; Other: Bach´s Flower Remedy

Study type: Interventional

Funder types: Other

Identifiers

NCT01324674

upeclin/HC/FMB-Unesp-50

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Is the group of subjects that will take placebo

Treatment:

Other: Placebo group

experimental group

Experimental group

Description:

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

Treatment:

Other: Bach´s Flower Remedy