Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder
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|ClinicalTrials.gov Identifier: NCT01324674|
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : January 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Mental Disorders Personal Well Being||Other: Bach´s Flower Remedy Other: Placebo group||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Relationship Between Treatment With Bach´s Flower Remedy and Spiritual Well-Being of People With Common Mental Disorder|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Placebo Comparator: Placebo group
Is the group of subjects that will take placebo
Other: Placebo group
The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months
Other Name: Complementary Alternative Therapy
Experimental: experimental group
Is the group of subjects that will take Bach´s Flower remedies
Other: Bach´s Flower Remedy
The subjects will have 4 drops 4 times per day, for approximately 8 months.
- Self-Reporting Questionnaire (SRQ-20) [ 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. ]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).
- Spiritual Index of Well-Being Scale (SIWBS) [ 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324674
|University of Vale do Paraíba|
|São José dos Campos, São Paulo, Brazil, 12244000|
|Study Chair:||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)|