<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03287583</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00067608</org_study_id>
    <nct_id>NCT03287583</nct_id>
  </id_info>
  <brief_title>SBIRT Intervention for Gambling Behaviors</brief_title>
  <official_title>Pilot Randomized Control Trial of an SBIRT Intervention for Gambling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Disordered gambling, like substance misuse, has been associated with various medical problems&#xD;
      and adverse health outcomes. The Maryland Center of Excellence on Problem Gambling, along&#xD;
      with experts in the fields of disordered gambling and behavior change, will work with the&#xD;
      Maryland State Department of Health and Mental Hygiene's Behavioral Health Administration to&#xD;
      develop a problem gambling-specific Screening, Brief Intervention and Referral to Treatment&#xD;
      (SBIRT) intervention targeting individuals receiving medical care in general primary care&#xD;
      clinics. The investigators will evaluate the feasibility and acceptability of inserting the&#xD;
      problem gambling intervention in to preexisting substance use SBIRT services being provided&#xD;
      in clinics in the state. In addition, the investigators will establish a clinic prevalence&#xD;
      for gambling and finally, conduct a randomized trial using the problem gambling SBIRT&#xD;
      intervention to see if it is effective in helping patients reduce their problematic gambling&#xD;
      behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Substance Abuse and Mental Health Services Administration (SAMHSA) has made health care&#xD;
      and health systems integration one of its main priorities to ensure that behavioral health is&#xD;
      consistently incorporated within the context of health care delivery systems. However, this&#xD;
      initiative has been focused on substance use disorders and mental health disorders that have&#xD;
      not included gambling disorder. Disordered gambling (DG) is highly associated with substance&#xD;
      use disorders, severe mental illness, depression, domestic violence and suicide. Disordered&#xD;
      gambling has also been linked with adverse health conditions and behaviors. Morasco et al.,&#xD;
      in their analysis of data from the National Epidemiologic Survey of Alcohol and Related&#xD;
      Conditions (NESARC), found that persons with DG were more likely to have a range of medical&#xD;
      problems including tachycardia, angina, cirrhosis or other liver disease. Even moderate&#xD;
      levels of gambling along with more severe levels of DG have been associated with adverse&#xD;
      health consequences and unhealthy life style factors. Morasco et al. report that at risk&#xD;
      gamblers (defined as gambling five or more times in the past 12 months) who they estimate&#xD;
      compose 25% of the population, were more likely to have experienced a severe injury in the&#xD;
      past year, receive emergency room treatment, have hypertension, be obese, have histories of&#xD;
      mood, anxiety, alcohol use and nicotine use disorders. In a more recent study, Black et al.&#xD;
      found individuals with DG were at higher risk for chronic medical conditions including&#xD;
      obesity, heartburn/stomach conditions, headaches, head injury with loss of consciousness,&#xD;
      sleep disorders, mood/emotional concerns, and anxiety, tension or stress. Individuals in the&#xD;
      DG group also were more likely to have poorer health habits. They were more likely to avoid&#xD;
      exercise, to drink alcohol while pregnant, smoke greater than or equal to a pack of&#xD;
      cigarettes per day to drink or more servings of caffeine a day and to watch or more hours of&#xD;
      television weekly. Subjects meeting DG criteria in this study were also less likely to have&#xD;
      regular dental check-ups and more likely to delay medical care for financial reasons.&#xD;
      Additionally the DG subjects were more likely to have at least one emergency room visit and&#xD;
      at least one hospitalization for mental health reasons in the past year.&#xD;
&#xD;
      Individuals with gambling problems have been found to utilize medical and behavioral health&#xD;
      services at higher rates.&#xD;
&#xD;
      Studies have also reported significant rates of gambling and problem gambling in primary care&#xD;
      settings. Pasternak and Fleming in a study of patients in primary care, that 80% had gambled&#xD;
      and 6.2% met criteria for problem gambling (score of 3 or more on South Oaks Gambling Screen,&#xD;
      SOGS). Additionally they report that gambling disorder was even more prevalent among&#xD;
      nonwhites and those from lower socioeconomic groups. In a study of individuals receiving free&#xD;
      or reduced-cost dental care, Morasco &amp; Petry found rates of problem gambling to be&#xD;
      significantly higher than the general population. In their sample, among those receiving&#xD;
      disability, 26% met criteria for disordered gambling and among those not receiving disability&#xD;
      14% met criteria based on SOGS scores. Other studies have found prevalence rates of gambling&#xD;
      problems of between 3 and 5% in primary care settings. However, these studies did not include&#xD;
      any frequency of gambling items nor an explanation of the range of behaviors meant by&#xD;
      &quot;gambling&quot; and have not included the less severe &quot;at risk&quot; gamblers. This study will also&#xD;
      address the need to improve the effectiveness of DG screening strategies in actual clinical&#xD;
      practice and to effectively identify not just those individuals who are exhibiting multiple&#xD;
      symptoms of gambling disorder but those fall into an &quot;at risk&quot; level of gambling that has&#xD;
      been associated with multiple poor health outcomes.&#xD;
&#xD;
      A prevalence study conducted in Maryland supports the likelihood of significant health issues&#xD;
      among those who are identified as at risk, problem or disordered gamblers. This study found&#xD;
      that 90% of adults in Maryland had gambled in their lifetimes. Over 21% had gambled at least&#xD;
      monthly in the past 12 months which would fit the definition of at risk gambling group that&#xD;
      compromised 25% of the subjects in the NESARC study who presented increased medical issues&#xD;
      and utilization. Those who had ever gambled as well the at risk and problem gambling groups&#xD;
      in the Maryland survey also reported higher levels of health risk behaviors (i.e. higher&#xD;
      alcohol intake, more frequent drug use, daily smoking) and reported poorer health status. The&#xD;
      rates of problem/pathological gambling for all adults was found to be 3.4% and at risk&#xD;
      gambling 9%. African Americans(17.3%) were found to have a significantly higher rate of at&#xD;
      risk as well as problem and disordered gambling compared to other ethic/racial groups (10.2%&#xD;
      white, 11.7% other ethnic/racial combined). The lowest socioeconomic group was also found to&#xD;
      have the highest rates of problem/pathological gambling (15%). Therefore, conducting gambling&#xD;
      specific screening and brief intervention in these high risk groups within Maryland is&#xD;
      strongly indicated.&#xD;
&#xD;
      While the research as sited above clearly indicates that individuals who are experiencing&#xD;
      gambling related harms in their lives are likely to experience higher rates of medical and&#xD;
      behavioral health problems and utilize health care services, they are not necessarily likely&#xD;
      to seek specific help for gambling problems. Strikingly, Kessler et al. reported that while&#xD;
      nearly half of their large national sample who met criteria for lifetime gambling disorder&#xD;
      received treatment for mental health or substance use disorders, none had received any&#xD;
      specific treatment for gambling problems. Indeed, it is estimated that only between 1 to 3%&#xD;
      of individuals nationwide who meet criteria for gambling disorder access gambling specific&#xD;
      treatment services.While this is in part due to internal factors in individuals with gambling&#xD;
      disorder such as desire to resolve problems on their own, shame, guilt and denial, there are&#xD;
      also provider/institutional factors that are significant. Primary among these is the absence&#xD;
      of screening for gambling problems.&#xD;
&#xD;
      Screening, Brief Intervention and Referral to Treatment (SBIRT) is an evidence based, public&#xD;
      health approach for delivery of early intervention services in medical and primary care&#xD;
      settings for individuals at risk for or experiencing substance use disorders. The most&#xD;
      extensive research evidence for the effectiveness of this approach has been with those&#xD;
      presenting indicators of alcohol abuse. Additionally Brief interventions (BI) have been found&#xD;
      to be effective for a range of non-alcohol substance abuse issues. While many studies have&#xD;
      demonstrated that brief interventions with disordered gamblers are effective, these studies&#xD;
      have not focused on identifying or providing brief interventions in actual clinical or&#xD;
      primary care settings. Research has suggested that there are considerable clinician as well&#xD;
      as client factors that contribute to reluctance to address the topic of gambling practice. To&#xD;
      our knowledge no study has sought to obtain both client and clinician input into the content&#xD;
      and process feasibility of providing screening and intervention for risk for GD in real&#xD;
      clinical settings to address clinician and client concerns.&#xD;
&#xD;
      Both research and treatment provider surveys have demonstrated that only a very small&#xD;
      percentage of individuals who experience gambling related harms are likely to seek treatment.&#xD;
      Furthermore, there is evidence that at risk gamblers who may comprise 20-25% of the adult&#xD;
      population are likely to experience increase levels of health related problems and utilize&#xD;
      health care services at higher rates than non/low-risk gamblers. However, has been little to&#xD;
      no research on how to effectively screen for risk for gambling in health care settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2023</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>participants will be randomized to receive either the Gambling Specific SBIRT Intervention or enhanced control.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>gambling time back follow-up</measure>
    <time_frame>one month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Gambling Disorder</condition>
  <arm_group>
    <arm_group_label>SBIRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SBIRT intervention for Gambling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants randomized to the enhanced control condition will receive a handout with gambling resources.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SBIRT for Gambing</intervention_name>
    <description>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.</description>
    <arm_group_label>SBIRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Control</intervention_name>
    <description>Participants randomized to the enhanced control condition will receive a handout with gambling resources.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults&#xD;
&#xD;
          -  Attending the recruitment clinic at University of Maryland&#xD;
&#xD;
          -  English Speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Madona Elias, MS</last_name>
    <phone>8595622275</phone>
    <email>madona.elias@uky.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Kentucky, SMART clinic</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Madona Elias, MS</last_name>
      <phone>859-562-2275</phone>
      <email>madona.elias@uky.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Christopher Welsh</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gambling</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03287583
org study id: HP-00067608
nct id: NCT03287583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: participants will be randomized to receive either the Gambling Specific SBIRT Intervention or enhanced control.
primary purpose: Treatment
masking: None (Open Label)
masking description: No masking
measure: gambling time back follow-up
time frame: one month
arm group label: SBIRT
arm group type: Experimental
description: SBIRT intervention for Gambling
arm group label: Control
arm group type: Other
description: Participants randomized to the enhanced control condition will receive a handout with gambling resources.
intervention type: Behavioral
intervention name: SBIRT for Gambing
description: 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.
arm group label: SBIRT
intervention type: Other
intervention name: Enhanced Control
description: Participants randomized to the enhanced control condition will receive a handout with gambling resources.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Madona Elias, MS
phone: 8595622275
email: madona.elias@uky.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Christopher Welsh
investigator title: Associate Professor
mesh term: Gambling
sharing ipd: Undecided