Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03287583 |
Other study ID # |
HP-00067608 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2023 |
Est. completion date |
November 8, 2023 |
Study information
Verified date |
February 2024 |
Source |
University of Maryland, Baltimore |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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.
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.