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

• ClinicalTrials.gov Identifier: NCT01324674
• Recruitment Status: Completed
• First Posted: March 29, 2011
• Last Update Posted: January 18, 2012
• Sponsor: UPECLIN HC FM Botucatu Unesp
• Collaborators: University of Sao Paulo; Universidade do Vale do Paraíba
• Information provided by (Responsible Party): Ana Paula Corrêa Castello Branco Nappi Arruda, UPECLIN HC FM Botucatu Unesp

Tracking Information

• First Submitted Date: February 21, 2011
• First Posted Date: March 29, 2011
• Last Update Posted Date: January 18, 2012
• Study Start Date: February 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2011)

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).

Original Primary Outcome Measures (submitted: March 28, 2011)

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 SRQ 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 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).

Current Secondary Outcome Measures (submitted: March 28, 2011)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Mental Disorders
• Personal Well Being

Intervention

• Other: Bach´s Flower Remedy
  The subjects will have 4 drops 4 times per day, for approximately 8 months.
  Other Names:

  • Complementary Alternative Therapy
  • Flower remedy
• 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

Study Arms

• Placebo Comparator: Placebo group
  Is the group of subjects that will take placebo
  Intervention: Other: Placebo group
• Experimental: experimental group
  Is the group of subjects that will take Bach´s Flower remedies
  Intervention: Other: Bach´s Flower Remedy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 16, 2012): 70
• Original Estimated Enrollment (submitted: March 28, 2011): 80
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01324674
• Other Study ID Numbers: upeclin/HC/FMB-Unesp-50
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ana Paula Corrêa Castello Branco Nappi Arruda, UPECLIN HC FM Botucatu Unesp
• Original Responsible Party: Ana Paula Corrêa Castello Branco Nappi Arruda, UNESP - Faculdade de medicina de Botucatu
• Current Study Sponsor: UPECLIN HC FM Botucatu Unesp
• Original Study Sponsor: Same as current

Collaborators

• University of Sao Paulo
• Universidade do Vale do Paraíba

Investigators

• 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)

• PRS Account: UPECLIN HC FM Botucatu Unesp
• Verification Date: March 2011