- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823601
Behavioral Management and Psychological Well-Being
April 2, 2013 updated by: Prof.Dr.José Roberto Leite, Centro de Estudos em Medicina Comportamental
A Cognitive-Behavioral Program Of Emotional Management and Feeling Of Psychological Well-Being
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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SP
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Sao Paulo, SP, Brazil, 04023-061
- Universidade Federal de Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Seminars in Health
This group of volunteers will attend to seminars in health.
Each seminar will last about 120 minutes, a similar period of time used for training experimental group.
|
Volunteers that participate in 10 weekly sessions of seminars in health
|
Experimental: Behavioral Management Program
"Behavioral Management Program" consists in to teach to the volunteers procedures which involve autogenic muscle relaxation, progressive self-focus meditation and cognitive-behavioral training to change thoughts, beliefs and behavior in order to control emotions.
This program will consist in 10 weekly sessions of about 120 minutes each.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depression and Anxiety scores in Beck Depression Inventory and Beck Anxiety Inventory
Time Frame: Up to 3 month
|
Up to 3 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of Well-Being scores in 6 factors of Psychological Well-Being in Ryff scale
Time Frame: Up to 3 month
|
Up to 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
March 30, 2013
First Submitted That Met QC Criteria
April 2, 2013
First Posted (Estimate)
April 4, 2013
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 2, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- UMC-04201301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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