Behavioral Management and Psychological Well-Being

Behavioral Management Clinical Trial

Official title:

A Cognitive-Behavioral Program Of Emotional Management and Feeling Of Psychological Well-Being

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823601
• Other study ID #: UMC-04201301
• Status: Completed
• Phase: N/A
• First received: March 30, 2013
• Last updated: April 2, 2013
• Start date: January 2013
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Centro de Estudos em Medicina Comportamental
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The aim of present study is to evaluate whether a program of behavioral and cognitive procedures for emotional control, and assertive training, produces well-being and improvement in quality of life of healthy volunteers.

Description:

Healthy volunteers,not presenting neurologic or psychiatric disorders, 18 years or older,both genders, were selected, after a medical examination, to participate in the study. In a randomized controlled trial, the volunteers were submitted to sessions of muscle relaxation (autogenic method), progressive self-focus meditation, and cognitive-behavioral training in self-control of negatives feelings. They were also trained to determine goals and to determine each step to reach them (plan of action).The volunteers have to apply this strategy to control emotional behavior and improve interpersonal relationship. Anxiety and depression scores will be determined using the Beck self evaluation scales (BDI and BAI); quality of life will be determined using WHO-QOL inventory and the Ryff Scale will be used to measure Psychological Well-Being.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy people, without neurological or psychiatry disorders, according to the results of a medical examination

• 18 years or older

• high school degree

Exclusion Criteria:

• Severe neurological or psychiatric disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Behavioral Management
• Psychological Well Being

Intervention

Behavioral:
• Behavioral Management Program
Consists in 10 Sessions of 120 minutes of duration, to train diaphragmatic breathing; autogenic training of muscle relaxation; progressive self-focus meditation and cognitive-behavioral training.
• Seminars in Health
Volunteers that participate in 10 weekly sessions of seminars in health

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Estudos em Medicina Comportamental

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression and Anxiety scores in Beck Depression Inventory and Beck Anxiety Inventory		Up to 3 month	No
Secondary	Evaluation of Well-Being scores in 6 factors of Psychological Well-Being in Ryff scale		Up to 3 month	No