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Gambling DisorderNCT03287583

SBIRT Intervention for Gambling Behaviors

A study testing SBIRT for Gambing in people with Gambling Disorder, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Disordered gambling, like substance misuse, has been associated with various medical problems and adverse health outcomes. The Maryland Center of Excellence on Problem Gambling, along with experts in the fields of disordered gambling and behavior change, will work with the Maryland State Department of Health and… Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Gambling Disorder
What is being tested?
SBIRT for Gambing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited States
Study dates
1 Mar 2023to 8 Nov 2023
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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults
  • Attending the recruitment clinic at University of Maryland
  • English Speaking

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky, SMART clinic

    Lexington, Kentucky, 40509

Other trials in United States

About this study

Official title: Pilot Randomized Control Trial of an SBIRT Intervention for Gambling

Disordered gambling, like substance misuse, has been associated with various medical problems and adverse health outcomes. The Maryland Center of Excellence on Problem Gambling, along with experts in the fields of disordered gambling and behavior change, will work with the Maryland State Department of Health and Mental Hygiene's Behavioral Health Administration to develop a problem gambling-specific Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention targeting individuals receiving medical care in general primary care clinics. The investigators will evaluate the feasibility and acceptability of inserting the problem gambling intervention in to preexisting substance use SBIRT services being provided in clinics in the state. In addition, the investigators will establish a clinic prevalence for gambling and finally, conduct a randomized trial using the problem gambling SBIRT intervention to see if it is effective in helping patients reduce their problematic gambling behaviors.

Read the detailed description

The Substance Abuse and Mental Health Services Administration (SAMHSA) has made health care and health systems integration one of its main priorities to ensure that behavioral health is consistently incorporated within the context of health care delivery systems. However, this initiative has been focused on substance use disorders and mental health disorders that have not included gambling disorder. Disordered gambling (DG) is highly associated with substance use disorders, severe mental illness, depression, domestic violence and suicide. Disordered gambling has also been linked with adverse health conditions and behaviors. Morasco et al., in their analysis of data from the National Epidemiologic Survey of Alcohol and Related Conditions (NESARC), found that persons with DG were more likely to have a range of medical problems including tachycardia, angina, cirrhosis or other liver disease. Even moderate levels of gambling along with more severe levels of DG have been associated with adverse health consequences and unhealthy life style factors. Morasco et al. report that at risk gamblers (defined as gambling five or more times in the past 12 months) who they estimate compose 25% of the population, were more likely to have experienced a severe injury in the past year, receive emergency room treatment, have hypertension, be obese, have histories of mood, anxiety, alcohol use and nicotine use disorders. In a more recent study, Black et al. found individuals with DG were at higher risk for chronic medical conditions including obesity, heartburn/stomach conditions, headaches, head injury with loss of consciousness, sleep disorders, mood/emotional concerns, and anxiety, tension or stress. Individuals in the DG group also were more likely to have poorer health habits. They were more likely to avoid exercise, to drink alcohol while pregnant, smoke greater than or equal to a pack of cigarettes per day to drink or more servings of caffeine a day and to watch or more hours of television weekly. Subjects meeting DG criteria in this study were also less likely to have regular dental check-ups and more likely to delay medical care for financial reasons. Additionally the DG subjects were more likely to have at least one emergency room visit and at least one hospitalization for mental health reasons in the past year.

Individuals with gambling problems have been found to utilize medical and behavioral health services at higher rates.

Studies have also reported significant rates of gambling and problem gambling in primary care settings. Pasternak and Fleming in a study of patients in primary care, that 80% had gambled and 6.2% met criteria for problem gambling (score of 3 or more on South Oaks Gambling Screen, SOGS). Additionally they report that gambling disorder was even more prevalent among nonwhites and those from lower socioeconomic groups. In a study of individuals receiving free or reduced-cost dental care, Morasco \& Petry found rates of problem gambling to be significantly higher than the general population. In their sample, among those receiving disability, 26% met criteria for disordered gambling and among those not receiving disability 14% met criteria based on SOGS scores. Other studies have found prevalence rates of gambling problems of between 3 and 5% in primary care settings. However, these studies did not include any frequency of gambling items nor an explanation of the range of behaviors meant by "gambling" and have not included the less severe "at risk" gamblers. This study will also address the need to improve the effectiveness of DG screening strategies in actual clinical practice and to effectively identify not just those individuals who are exhibiting multiple symptoms of gambling disorder but those fall into an "at risk" level of gambling that has been associated with multiple poor health outcomes.

A prevalence study conducted in Maryland supports the likelihood of significant health issues among those who are identified as at risk, problem or disordered gamblers. This study found that 90% of adults in Maryland had gambled in their lifetimes. Over 21% had gambled at least monthly in the past 12 months which would fit the definition of at risk gambling group that compromised 25% of the subjects in the NESARC study who presented increased medical issues and utilization. Those who had ever gambled as well the at risk and problem gambling groups in the Maryland survey also reported higher levels of health risk behaviors (i.e. higher alcohol intake, more frequent drug use, daily smoking) and reported poorer health status. The rates of problem/pathological gambling for all adults was found to be 3.4% and at risk gambling 9%. African Americans(17.3%) were found to have a significantly higher rate of at risk as well as problem and disordered gambling compared to other ethic/racial groups (10.2% white, 11.7% other ethnic/racial combined). The lowest socioeconomic group was also found to have the highest rates of problem/pathological gambling (15%). Therefore, conducting gambling specific screening and brief intervention in these high risk groups within Maryland is strongly indicated.

While the research as sited above clearly indicates that individuals who are experiencing gambling related harms in their lives are likely to experience higher rates of medical and behavioral health problems and utilize health care services, they are not necessarily likely to seek specific help for gambling problems. Strikingly, Kessler et al. reported that while nearly half of their large national sample who met criteria for lifetime gambling disorder received treatment for mental health or substance use disorders, none had received any specific treatment for gambling problems. Indeed, it is estimated that only between 1 to 3% of individuals nationwide who meet criteria for gambling disorder access gambling specific treatment services.While this is in part due to internal factors in individuals with gambling disorder such as desire to resolve problems on their own, shame, guilt and denial, there are also provider/institutional factors that are significant. Primary among these is the absence of screening for gambling problems.

Screening, Brief Intervention and Referral to Treatment (SBIRT) is an evidence based, public health approach for delivery of early intervention services in medical and primary care settings for individuals at risk for or experiencing substance use disorders. The most extensive research evidence for the effectiveness of this approach has been with those presenting indicators of alcohol abuse. Additionally Brief interventions (BI) have been found to be effective for a range of non-alcohol substance abuse issues. While many studies have demonstrated that brief interventions with disordered gamblers are effective, these studies have not focused on identifying or providing brief interventions in actual clinical or primary care settings. Research has suggested that there are considerable clinician as well as client factors that contribute to reluctance to address the topic of gambling practice. To our knowledge no study has sought to obtain both client and clinician input into the content and process feasibility of providing screening and intervention for risk for GD in real clinical settings to address clinician and client concerns.

Both research and treatment provider surveys have demonstrated that only a very small percentage of individuals who experience gambling related harms are likely to seek treatment. Furthermore, there is evidence that at risk gamblers who may comprise 20-25% of the adult population are likely to experience increase levels of health related problems and utilize health care services at higher rates than non/low-risk gamblers. However, has been little to no research on how to effectively screen for risk for gambling in health care settings.

Being tested
SBIRT for Gambing, Enhanced Control
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBIRT for GambingBehavioural

    The SBIRT intervention uses a brief gambling screening assessment to determine whether or not a participant is at risk for problem gambling. This is followed by a structured short brief intervention to assist people in better understanding their risk for gambling and what they can do to limit that risk.

  • Enhanced ControlOther

    Participants randomized to the enhanced control condition will receive a handout with gambling resources.

Study groups in NCT03287583
Study groupRoleWhat they receive
SBIRTExperimentalSBIRT intervention for Gambling
Receives: Behavioral: SBIRT for Gambing
ControlOtherParticipants randomized to the enhanced control condition will receive a handout with gambling resources.
Receives: Other: Enhanced Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. gambling time back follow-up

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2017
  2. Study start1 Mar 2023
  3. Primary completion8 Nov 2023
  4. Study completion8 Nov 2023

Resources

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
Model description
participants will be randomized to receive either the Gambling Specific SBIRT Intervention or enhanced control.
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03287583
Sponsor's protocol ID
HP-00067608
Status last verified
Feb 2024
First submitted
15 Sep 2017
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing SBIRT for Gambing in people with Gambling Disorder, run by University of Maryland, Baltimore at 1 site in United States.

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 3 inclusion and 1 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 15 Feb 2024. 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 United States. 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 time back follow-up (time frame: one month). 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 15 Feb 2024.

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