Physical Activity Pathological Gamblers

Gambling Disorder Clinical Trial

Official title:

The Impact of Aerobic Physical Activity on Aspects of Impulsivity and Negative Affectivity in Pathological Gamblers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354702
• Other study ID #: physical and pathological gamb
• Status: Completed
• Phase: N/A
• Start date: March 12, 2017
• Est. completion date: May 20, 2018

Study information

• Verified date: November 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 20, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gambling
• Gambling Disorder

Intervention

Other:
• Aerobic
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.
• Stretching
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.

Locations

Country	Name	City	State
Brazil	Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Eight weeks
Primary	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.	Eight weeks
Secondary	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).	Eight weeks
Secondary	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).	Eight weeks
Secondary	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.	Eight weeks
Secondary	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.	Eight weeks
Secondary	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.	Eight weeks