Clinical trial NCT03354702: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gambling Disorder
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2017-11-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gambling Follow-up scale (GFS)
timeFrame: Eight weeks
measure: International Neuropsychiatric Interview
timeFrame: Eight weeks
Secondary outcomes:
measure: Gambling Symptom Assessment Scale (GSA-S).
timeFrame: Eight weeks
measure: Barratt Impulsiveness Scale (BIS-11)
timeFrame: Eight weeks
measure: GoStop Impulsivity Paradigm.
timeFrame: Eight weeks
measure: Delay DiscountingTask (DDT).
timeFrame: Eight weeks
measure: The Rey-Osterrieth Complex Figure Test
timeFrame: Eight weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: HERMANO TAVARES, MD
role: PRINCIPAL_INVESTIGATOR
References: