Psychological Well BeingNCT01823601
Behavioral Management and Psychological Well-Being
A study testing Behavioral Management Program and Seminars in Health in people with Psychological Well Being and Behavioral Management, run by Centro de Estudos em Medicina Comportamental at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Well Being, Behavioral Management
- What is being tested?
- Behavioral Management Program and Seminars in Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy people, without neurological or psychiatry disorders, according to the results of a medical examination
- 18 years or older
- high school degree
Who cannot join
- Severe neurological or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Psychological Well Being, Behavioral Management
- Being tested
- Behavioral Management Program, Seminars in Health
- Keywords
- Well-Being, Life Management Program, Breathing, Meditation, Cognitive-Behavioral Training
- Medical subject headings
- Psychological Well-Being, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Management ProgramBehavioural
Also called Life 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 HealthBehavioural
Volunteers that participate in 10 weekly sessions of seminars in health
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral Management Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression and Anxiety scores in Beck Depression Inventory and Beck Anxiety Inventory
Measured: Up to 3 month
Secondary outcomes (1)
Evaluation of Well-Being scores in 6 factors of Psychological Well-Being in Ryff scale
Measured: Up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well BeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Estudos em Medicina Comportamental
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Dr.José Roberto Leite, Centro de Estudos em Medicina Comportamental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823601
- Sponsor's protocol ID
- UMC-04201301
- Status last verified
- Mar 2013
- First submitted
- 30 Mar 2013
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive-Behavioral Program Of Emotional Management and Feeling Of Psychological Well-Being
- ClinicalTrials.gov ID
- NCT01823601
- Acronym / sponsor ID
- UMC-04201301
- Conditions
- Psychological Well Being, Behavioral Management
- Keywords
- Well-Being, Life Management Program, Breathing, Meditation, Cognitive-Behavioral Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centro de Estudos em Medicina ComportamentalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seminars in Health | Active comparator | Behavioral: Seminars in HealthThis 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 Management Program | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy people, without neurological or psychiatry disorders, according to the results of a medical examination
- 18 years or older
- high school degree
Key exclusion criteria (1 listed)
- Severe neurological or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Management ProgramAlso: Life Management ProgramConsists 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. | Behavioural | Behavioral Management Program |
| Seminars in HealthVolunteers that participate in 10 weekly sessions of seminars in health | Behavioural | Seminars in Health |
Primary outcome
Depression and Anxiety scores in Beck Depression Inventory and Beck Anxiety Inventory
Time frame: Up to 3 month
1 secondary outcome
Evaluation of Well-Being scores in 6 factors of Psychological Well-Being in Ryff scale
Time frame: Up to 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Related trials for Psychological Well Being
Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Active, not recruiting
Improving Emotional Wellbeing of University Students: Anxiety Management
Anxiety
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Not yet recruiting
Effects of Positive Psychology on Hope, Gratitude, and Well-Being
Elderly, Nursing Homes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Management Program and Seminars in Health in people with Psychological Well Being and Behavioral Management, run by Centro de Estudos em Medicina Comportamental at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression and Anxiety scores in Beck Depression Inventory and Beck Anxiety Inventory (time frame: Up to 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.