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Physical Activity Pathological Gamblers

Primary Purpose

Gambling Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic
Stretching
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group aerobic activity (experimental)

Group stretching (control)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
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.
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.
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.

Full Information

First Posted
September 11, 2017
Last Updated
November 16, 2020
Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT03354702
Brief Title
Physical Activity Pathological Gamblers
Official Title
The Impact of Aerobic Physical Activity on Aspects of Impulsivity and Negative Affectivity in Pathological Gamblers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
May 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group aerobic activity (experimental)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group stretching (control)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Aerobic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gambling Follow-up scale (GFS)
Description
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.
Time Frame
Eight weeks
Title
International Neuropsychiatric Interview
Description
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.
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Gambling Symptom Assessment Scale (GSA-S).
Description
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).
Time Frame
Eight weeks
Title
Barratt Impulsiveness Scale (BIS-11)
Description
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).
Time Frame
Eight weeks
Title
GoStop Impulsivity Paradigm.
Description
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.
Time Frame
Eight weeks
Title
Delay DiscountingTask (DDT).
Description
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.
Time Frame
Eight weeks
Title
The Rey-Osterrieth Complex Figure Test
Description
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.
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HERMANO TAVARES, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

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Physical Activity Pathological Gamblers

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