Physical Activity Pathological Gamblers

NCT03354702 | Completed DMC

• 1 other identifier: physical and pathological gamb
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gambling Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Gambling Symptom Assessment Scale (GSA-S).

  Eight weeks

• Barratt Impulsiveness Scale (BIS-11)

  Eight weeks

• GoStop Impulsivity Paradigm.

  Eight weeks

• Delay DiscountingTask (DDT).

  Eight weeks

• The Rey-Osterrieth Complex Figure Test

  Eight weeks

Study Arms (2)

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.

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

Other: Stretching

Interventions

Aerobic OTHER

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.

Group aerobic activity (experimental)

Stretching OTHER

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.

Group stretching (control)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

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

São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Study Officials

• HERMANO TAVARES, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: November 28, 2017
• Study Start: March 12, 2017
• Primary Completion: February 28, 2018
• Study Completion: May 20, 2018
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

BR (1)