Gambling DisorderNCT03354702
Physical Activity Pathological Gamblers
A study testing Aerobic and Stretching in people with Gambling Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Aerobic and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Mar 2017to 20 May 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05403000
About this study
Official title: 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.
Read the 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.
- Conditions
- Gambling Disorder
- Being tested
- Aerobic, Stretching
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AerobicOther
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.
StretchingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group aerobic activity (experimental) | 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. Receives: Other: Aerobic |
| Group stretching (control) | Active comparator | 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 Receives: Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gambling Follow-up scale (GFS)
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.
Measured: Eight weeks
International Neuropsychiatric Interview
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.
Measured: Eight weeks
Secondary outcomes (5)
Gambling Symptom Assessment Scale (GSA-S).
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).
Measured: Eight weeks
Barratt Impulsiveness Scale (BIS-11)
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).
Measured: Eight weeks
GoStop Impulsivity Paradigm.
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.
Measured: Eight weeks
Delay DiscountingTask (DDT).
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.
Measured: Eight weeks
The Rey-Osterrieth Complex Figure Test
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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start12 Mar 2017
- Primary completion28 Feb 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Hermano Tavares, University of Sao Paulo
- Investigators
- HERMANO TAVARES, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354702
- Sponsor's protocol ID
- physical and pathological gamb
- Status last verified
- Nov 2020
- First submitted
- 11 Sep 2017
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Aerobic Physical Activity on Aspects of Impulsivity and Negative Affectivity in Pathological Gamblers
- ClinicalTrials.gov ID
- NCT03354702
- Acronym / sponsor ID
- physical and pathological gamb
- Conditions
- Gambling Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 28 Nov 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group aerobic activity (experimental) | Experimental | Other: AerobicGroup 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. |
| Group stretching (control) | Active comparator | Other: StretchingGroup 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| AerobicAerobic 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. | Other | Group aerobic activity (experimental) |
| StretchingStretching 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. | Other | Group stretching (control) |
Primary outcome
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.
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.
5 secondary outcomes
Gambling Symptom Assessment Scale (GSA-S).
Time frame: Eight weeks
Barratt Impulsiveness Scale (BIS-11)
Time frame: Eight weeks
GoStop Impulsivity Paradigm.
Time frame: Eight weeks
Delay DiscountingTask (DDT).
Time frame: Eight weeks
The Rey-Osterrieth Complex Figure Test
Time frame: Eight weeks
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 17 Nov 2020.
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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.
HERMANO TAVARES, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and Stretching in people with Gambling Disorder, run by University of Sao Paulo 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 4 inclusion and 5 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 17 Nov 2020. 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?
Gambling Follow-up scale (GFS) (time frame: Eight weeks). The study lists 2 primary outcomes in all. 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 17 Nov 2020.