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

Primary Purpose

Mental Disorders, Personal Well Being

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Bach´s Flower Remedy
Placebo group
Sponsored by
UPECLIN HC FM Botucatu Unesp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Common Mental Disorder, Efficacy of Bach´s flower remedy, Spiritual well-being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Vale do Paraíba

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

experimental group

Arm Description

Is the group of subjects that will take placebo

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Spiritual Index of Well-Being Scale (SIWBS)
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.

Full Information

First Posted
February 21, 2011
Last Updated
January 16, 2012
Sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
University of Sao Paulo, Universidade do Vale do Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT01324674
Brief Title
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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UPECLIN HC FM Botucatu Unesp
Collaborators
University of Sao Paulo, Universidade do Vale do Paraíba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Personal Well Being
Keywords
Common Mental Disorder, Efficacy of Bach´s flower remedy, Spiritual well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Is the group of subjects that will take placebo
Arm Title
experimental group
Arm Type
Experimental
Arm Description
Is the group of subjects that will take Bach´s Flower remedies
Intervention Type
Other
Intervention Name(s)
Bach´s Flower Remedy
Other Intervention Name(s)
Complementary Alternative Therapy, Flower remedy
Intervention Description
The subjects will have 4 drops 4 times per day, for approximately 8 months.
Intervention Type
Other
Intervention Name(s)
Placebo group
Other Intervention Name(s)
Complementary Alternative Therapy
Intervention Description
The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months
Primary Outcome Measure Information:
Title
Self-Reporting Questionnaire (SRQ-20)
Description
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).
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.
Secondary Outcome Measure Information:
Title
Spiritual Index of Well-Being Scale (SIWBS)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan A Guerrini, PhD
Organizational Affiliation
Medical School of São Paulo State University (UNESP)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ruth Turrini, PhD
Organizational Affiliation
Nursing School of University of São Paulo - (EEUSP)
Official's Role
Study Chair
Facility Information:
Facility Name
University of Vale do Paraíba
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12244000
Country
Brazil

12. IPD Sharing Statement

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

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