NCT01823601

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
Last Updated

April 4, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

March 30, 2013

Last Update Submit

April 2, 2013

Conditions

Keywords

Well-BeingLife Management ProgramBreathingMeditationCognitive-Behavioral Training

Outcome Measures

Primary Outcomes (1)

  • Depression and Anxiety scores in Beck Depression Inventory and Beck Anxiety Inventory

    Up to 3 month

Secondary Outcomes (1)

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

    Up to 3 month

Study Arms (2)

Seminars in Health

ACTIVE COMPARATOR

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

Behavioral Management Program

EXPERIMENTAL

"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

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
Behavioral Management Program

Volunteers that participate in 10 weekly sessions of seminars in health

Seminars in Health

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy people, without neurological or psychiatry disorders, according to the results of a medical examination
  • years or older
  • high school degree

You may not qualify if:

  • Severe neurological or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023-061, Brazil

Location

MeSH Terms

Conditions

Psychological Well-BeingRespiratory Aspiration

Interventions

Health

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 30, 2013

First Posted

April 4, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-03

Locations