Clinical trial NCT01324674: Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder
Official title: Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mental Disorders
Personal Well Being
Keywords: Common Mental Disorder
Efficacy of Bach´s flower remedy
Spiritual well-being
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Universidade do Vale do Paraíba
First posted: 2011-03-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Self-Reporting Questionnaire (SRQ-20)
timeFrame: (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:
measure: Spiritual Index of Well-Being Scale (SIWBS)
timeFrame: (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
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: University of Vale do Paraíba
state: São Paulo
Study officials:
affiliation: Medical School of São Paulo State University (UNESP)
name: Ivan A Guerrini, PhD
role: STUDY_CHAIR
affiliation: Nursing School of University of São Paulo - (EEUSP)
name: Ruth Turrini, PhD
role: STUDY_CHAIR
References: