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CompletedNCT01823601Updated Apr 4, 2013

Behavioral Management and Psychological Well-Being

An interventional study of Behavioral Management Program and Seminars in Health in Psychological Well Being and Behavioral Management, sponsored by Centro de Estudos em Medicina Comportamental. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-04.

Sponsored by Centro de Estudos em Medicina Comportamental · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Psychological Well Being
  • Behavioral Management

Keywords

  • Well-Being
  • Life Management Program
  • Breathing
  • Meditation
  • Cognitive-Behavioral Training
03

In context

Lead sponsor

This is the only study on the registry with Centro de Estudos em Medicina Comportamental as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Severe neurological or psychiatric disorders
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • 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.

    Behavioral: 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.

    Behavioral: Behavioral Management Program

Interventions

  • BehavioralBehavioral 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.

    Also known as: Life Management Program

  • BehavioralSeminars in Health

    Volunteers that participate in 10 weekly sessions of seminars in health

06

What researchers measure

Primary outcomes

  1. Depression and Anxiety scores in Beck Depression Inventory and Beck Anxiety Inventory

    Time frame: Up to 3 month

Secondary outcomes

  1. Evaluation of Well-Being scores in 6 factors of Psychological Well-Being in Ryff scale

    Time frame: Up to 3 month

07

Study locations

1 site
  • Universidade Federal de Sao Paulo
    Sao Paulo, SP 04023-061, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01823601
Lead sponsor
Centro de Estudos em Medicina Comportamental
Responsible party
Prof.Dr.José Roberto Leite (Director, Centro de Estudos em Medicina Comportamental) — Principal investigator
First posted
Apr 4, 2013
Start date
Jan 2013
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Apr 4, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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