- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03354702
Physical Activity Pathological Gamblers
November 16, 2020 updated by: Hermano Tavares, University of Sao Paulo
The Impact of Aerobic Physical Activity on Aspects of Impulsivity and Negative Affectivity in Pathological Gamblers
Gambling Disorder (GD) is defined as the recurrent and persistent act of betting which leads to clinical impairments,.
The latest edition of the Diagnostic and Statistical Manual of Mental Disorders (5th edition) conceptualizes GD as a behavioral addiction due to the similarities between GD and substance addictions in clinical presentation, association with personality factors, genetic transmission and treatment options.
Previous studies found potential benefits of physical activity in treatment of addictions in general and GD in particular, such as reducing desire to play, betting and depressive and anxious symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Detailed Description: The purpose of this study is to investigate the effects of regular physical activity controlled and supervised in the treatment of gambling disorder with focus on gambling severity, psychiatric comorbidity and impulsiveness.
Patients will undergo physical activity either running (experimental) or stretching (control) groups,.
Physical activity sessions will be lead by a physical educator.,
Both groups will receive treatment for psychiatric comorbidities and cognitive behavioral psychoeducation.
Study Type
Interventional
Enrollment (Actual)
24
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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-
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São Paulo, Brazil, 05403000
- Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo
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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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Five or more diagnostic criteria for pathological gambling specified in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR - APA, 2000);
- At least four years of formal education;
- Able to perform physical activity;
- Non-pregnant.
Exclusion criteria:
- Clinical pathology that demands urgent care such as hospitalization in another service;
- Any cardiorespiratory, musculoskeletal, or clinical condition that could prevent the practice of aerobic activity, established in clinical evaluation prior to randomization;
- Psychotic disorder that may undermine validity of responses to the self-report scales administered;
- Condition which affects the central nervous system and seriously impairs cognitive functions, as a disorder oligophrenia;
- Diagnosis of moderate to severe depression that compromises engagement in physical activity.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group aerobic activity (experimental)
Group aerobic exercise (experimental).
Patients perform aerobic exercise per 30 minutes (moderate intensity: 70% to 85% of estimated maximum heart rate), more 10 minutes stretching, once a week monitored and once without monitoring and patients have medical appointment with psychiatrist and make psychotherapy sessions.
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Aerobic exercise Patients performs 8 sessions of aerobic exercise (walking / running),with monitoring and 8 sessions without monitoring totaling 16 sessions and patients have medical appointment with psychiatrist and make psychotherapy sessions.
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Active Comparator: Group stretching (control)
Group stretching (control).
Patients perform stretching per 30 minutes, once a week monitored and once without monitoring and patients have medical appointment with psychiatrist and make psychotherapy sessions
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Stretching Patients performs 8 sessions of stretching, with monitoring and 8 sessions without monitoring totaling 16 sessions and patients have medical appointment with psychiatrist and make psychotherapy sessions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gambling Follow-up scale (GFS)
Time Frame: Eight weeks
|
This questionnaire is meant to assess gambling severity and it investigates financial issues, family relationships, emotional distress, and satisfaction with leisure, in addition to gambling behavior.
|
Eight weeks
|
International Neuropsychiatric Interview
Time Frame: Eight weeks
|
The MINI is a brief psychiatric interview that has strong psychometric properties including reliable diagnoses as compared to the Composite International Diagnostic Interview and the Structured Clinical Interview for the DSMpsychiatric disorder in axis I of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) of American Psychiatric Association in 1994.
International Neuropsychiatric Interview takes approximately 15 minutes.
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Eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gambling Symptom Assessment Scale (GSA-S).
Time Frame: Eight weeks
|
The G-SAS is a 12-item instrument which was designed to evaluate gambling symptoms.
Each item is scored on a 5-point Likert scale from 0 'none' or 'complete' to 4 'extreme' or 'no control'.
Scores range from 0 to 48 with four severity categories: mild (8-20), moderate (21-30), severe (31-40), and extreme (41-48).
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Eight weeks
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Barratt Impulsiveness Scale (BIS-11)
Time Frame: Eight weeks
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It is a self-report scale consisting of 30 questions that provides a total score (minimum of 30 and maximum of 120) resulting from the sum of three sub-factors, namely: lack of attention, that is, cognitive impulsivity (i.e., decisions made in haste), motor impulsivity (i.e., acts without thinking) and non-planning (i.e., behaviors performed without future perspective).
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Eight weeks
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GoStop Impulsivity Paradigm.
Time Frame: Eight weeks
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GoStop Impulsivity Paradigm evaluates the capacity of inhibitory control.
GoStop Impulsivity Paradigm is a "stop task" designed to measure response inhibition.
The primary response of interest here is the failure to inhibit responding when a "go" cue is unexpectedly accompanied by a "stop" cue.
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Eight weeks
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Delay DiscountingTask (DDT).
Time Frame: Eight weeks
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In the Delay Discount Test (DDT) the subject is faced with a hypothetical choice, for example receiving US$ 1,000.00 in 6 hours, or US$ 999.00 now.
The value of the present reward is presented in descending order until the subject chooses to wait for the delayed reward.
The value immediately prior to this change is called the point of indifference.
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Eight weeks
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The Rey-Osterrieth Complex Figure Test
Time Frame: Eight weeks
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The Rey-Osterrieth Complex Figure Test assesses visuospatial organization and planning abilities.
The subject has to copy a complex geometric figure.
A score is calculated for the drawing taking into account number of details, reproduction strategy, and drawing organization.
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Eight weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: HERMANO TAVARES, MD, University of Sao Paulo
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 (Actual)
March 12, 2017
Primary Completion (Actual)
February 28, 2018
Study Completion (Actual)
May 20, 2018
Study Registration Dates
First Submitted
September 11, 2017
First Submitted That Met QC Criteria
November 27, 2017
First Posted (Actual)
November 28, 2017
Study Record Updates
Last Update Posted (Actual)
November 17, 2020
Last Update Submitted That Met QC Criteria
November 16, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- physical and pathological gamb
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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