GamblingPhase 2NCT00078273
Indicated Prevention With At-Risk Gamblers
A Phase 2 study testing Personalized Feedback Intervention and Cognitive Behavioral Intervention in people with Gambling and Pathological Gambling, run by University of Washington at 1 site in United States.
Trial summary
The overall purpose of this study is to reduce the prevalence of gambling risk in college students by evaluating the effectiveness of different treatments in reducing gambling behavior and related negative consequences. Read more about this study
- Who is it for?
- Ages 17 to 24 years
- Conditions the study is for
- Gambling, Pathological Gambling, Problem Gambling
- What is being tested?
- Personalized Feedback Intervention and Cognitive Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jul 2003
- Phase
- Phase 2
- 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 17 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- College student
- South Oaks Gambling Screen (SOGS) score greater than 3
Who cannot join
- None, other than not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington; Department of Psychiatry and Behavioral Sciences
Seattle, Washington, 98195
About this study
The overall purpose of this study is to reduce the prevalence of gambling risk in college students by evaluating the effectiveness of different treatments in reducing gambling behavior and related negative consequences.
Read the detailed description
Participants in this study will be randomly assigned to a personal feedback intervention (PFI) or assessment only for 3 years. The PFI intervention will be delivered in a single session. Measures will include the NORC DSM Screen for Problem Gambling (NODS), the South Oaks Gambling Screen (SOGS), Gambling Quantity and Perceived Norms, Perceived Injunctive Gambling Norms, Gambling Problems Index, gambling frequency, attitudes and beliefs about gambling and self-control, readiness to change, gambling expectancies, gambling motives, gambling risk perception, psychiatric symptoms, assertiveness, coping skills, substance use, alcohol-related problems, self-determination, and social desirability.
- Conditions
- Gambling, Pathological Gambling, Problem Gambling
- Being tested
- Personalized Feedback Intervention, Cognitive Behavioral Intervention
- Keywords
- Gambling, Pathological Gambling, Problem Gambling, College Students, Prevention
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Feedback InterventionBehavioural
Sessions lasted for 60-90 minutes and used Motivational Interviewing (MI) to facilitate discussion of feedback from participants' survey responses. Sessions began with open-ended questions about contextual factors associated with participants' gambling, then review of each feedback section: gambling pattern; perceived gambling norms; positive expectancies and negative consequences of gambling; beliefs about control over gambling; and situational self-efficacy to avoid gambling. Participants were encouraged to consider the feedback in light of their personal goals. All participants received a copy of their feedback, a list of skills for limiting gambling and a resource/referral list.
Cognitive Behavioral InterventionBehavioural
Participants completed either six weekly 1-hour sessions or attend four sessions containing the same content. Sessions covered functional analysis and gambling triggers; challenging cognitive distortions, with emphasis on illusions of control; coping with triggers; assertiveness; and relapse prevention. Participants received a pamphlet covering each week's topic (which was reviewed with the participant if a session was missed), as well as homework sheets and gambling diaries. CBI participants were asked to refrain from gambling for the duration of the group to provide an opportunity to practice and develop skills applicable to gambling and other behavior change situations.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Only Control | No intervention | Completed Baseline and 6 month follow-up surveys only. |
| Personalized Feedback Intervention | Experimental | See Intervention Description Receives: Behavioral: Personalized Feedback Intervention |
| Cognitive Behavioral Intervention | Experimental | See Intervention Description Receives: Behavioral: Cognitive Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
South Oaks Gambling Screen (SOGS)
The 20-item South Oaks Gambling Screen (SOGS) measures gambling involvement and problem severity based on DSM-III-R pathological gambling criteria.
Measured: 6-Months
Gambling Quantity and Perceived Norms Scale (GQPN)
The gambling quantity and perceived norms scale (GQPN) includes a six-item expenditure subscale assessing amount of money won/lost through gambling on a 10-point scale from $0 to more than $2000 over time-periods from the past month to past year. Additional items assess gambling frequency (on a 10-point scale from never to every day in the past year), disposable income (on an 11-point scale from less than $50 to more than $500 per month) and perceptions of gambling frequency and expenditure for the typical college student (perceived norms). Gambling expenditure was calculated as the expenditure subscale mean residualized on disposable income.
Measured: 6 Months
Gambling Frequency (SOGS)
The SOGS was modified to assess internet gambling frequency and expand gambling frequency response options from a three- to a five-point scale with anchors of no times, one to 10 times, more than 10 times, less than weekly, weekly or more than weekly but less than daily, and daily. This modified frequency scale has been shown to correlate highly with other measures of gambling frequency.
Measured: 6 Months
Gambling Problems Index (GPI)
Gambling problems (or negative consequences) were assessed using the 20-item Gambling Problems Index (GPI). Participants indicated how often, from never to more than 10 times in the past 6 months, they experienced consequences while, or as a result of, gambling.
Measured: 6 Months
National Opinion Research Center DSM-IV Screen for Pathological Gambling (NODS)
DSM-IV [1] criteria for pathological gambling were assessed using the 17-item National Opinion Research Center DSM-IV Screen (NODS). Some criteria have multiple items, but possible scores range from 0-10 DSM-IV criteria endorsed in the past 6 months.
Measured: 6 Months
Secondary outcomes (1)
Illusions of Control
Illusions of control were assessed via a six-item subscale from the Beliefs About Control Scale (BACS), on a five-point scale ranging from strongly disagree to strongly agree.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2004 (estimated)
- Study startJul 2003
- Primary completionJul 2003
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GamblingStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mary Larimer, University of Washington
- Investigators
- Mary E Larimer, Ph.D, Principal investigator, University of Washington, Dept of Psychiatry & Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078273
- Sponsor's protocol ID
- 23848-C
- Other IDs
- R21MH067026, DATR A2-AII
- Status last verified
- Dec 2013
- First submitted
- 20 Feb 2004
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larimer ME, Neighbors C, Lostutter TW, Whiteside U, Cronce JM, Kaysen D, Walker DD. Brief motivational feedback and cognitive behavioral interventions for prevention of disordered gambling: a randomized clinical trial. Addiction. 2012 Jun;107(6):1148-58. doi: 10.1111/j.1360-0443.2011.03776.x. Epub 2012 Feb 28.
PubMed 22188239
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indicated Prevention With At-Risk Gamblers
- ClinicalTrials.gov ID
- NCT00078273
- Acronym / sponsor ID
- 23848-C
- Conditions
- Gambling, Pathological Gambling, Problem Gambling
- Keywords
- Gambling, Pathological Gambling, Problem Gambling, College Students, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2003
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 24 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this study is to reduce the prevalence of gambling risk in college students by evaluating the effectiveness of different treatments in reducing gambling behavior and related negative consequences.
Detailed description
Participants in this study will be randomly assigned to a personal feedback intervention (PFI) or assessment only for 3 years. The PFI intervention will be delivered in a single session. Measures will include the NORC DSM Screen for Problem Gambling (NODS), the South Oaks Gambling Screen (SOGS), Gambling Quantity and Perceived Norms, Perceived Injunctive Gambling Norms, Gambling Problems Index, gambling frequency, attitudes and beliefs about gambling and self-control, readiness to change, gambling expectancies, gambling motives, gambling risk perception, psychiatric symptoms, assertiveness, coping skills, substance use, alcohol-related problems, self-determination, and social desirability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Assessment Only Control | No intervention | –Completed Baseline and 6 month follow-up surveys only. |
| Personalized Feedback Intervention | Experimental | Behavioral: Personalized Feedback InterventionSee Intervention Description |
| Cognitive Behavioral Intervention | Experimental | Behavioral: Cognitive Behavioral InterventionSee Intervention Description |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- College student
- South Oaks Gambling Screen (SOGS) score greater than 3
Key exclusion criteria (1 listed)
- None, other than not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Feedback InterventionSessions lasted for 60-90 minutes and used Motivational Interviewing (MI) to facilitate discussion of feedback from participants' survey responses. Sessions began with open-ended questions about contextual factors associated with participants' gambling, then review of each feedback section: gambling pattern; perceived gambling norms; positive expectancies and negative consequences of gambling; beliefs about control over gambling; and situational self-efficacy to avoid gambling. Participants were encouraged to consider the feedback in light of their personal goals. All participants received a copy of their feedback, a list of skills for limiting gambling and a resource/referral list. | Behavioural | Personalized Feedback Intervention |
| Cognitive Behavioral InterventionParticipants completed either six weekly 1-hour sessions or attend four sessions containing the same content. Sessions covered functional analysis and gambling triggers; challenging cognitive distortions, with emphasis on illusions of control; coping with triggers; assertiveness; and relapse prevention. Participants received a pamphlet covering each week's topic (which was reviewed with the participant if a session was missed), as well as homework sheets and gambling diaries. CBI participants were asked to refrain from gambling for the duration of the group to provide an opportunity to practice and develop skills applicable to gambling and other behavior change situations. | Behavioural | Cognitive Behavioral Intervention |
Primary outcome
South Oaks Gambling Screen (SOGS)
Time frame: 6-Months
The 20-item South Oaks Gambling Screen (SOGS) measures gambling involvement and problem severity based on DSM-III-R pathological gambling criteria.
Gambling Quantity and Perceived Norms Scale (GQPN)
Time frame: 6 Months
The gambling quantity and perceived norms scale (GQPN) includes a six-item expenditure subscale assessing amount of money won/lost through gambling on a 10-point scale from $0 to more than $2000 over time-periods from the past month to past year. Additional items assess gambling frequency (on a 10-point scale from never to every day in the past year), disposable income (on an 11-point scale from less than $50 to more than $500 per month) and perceptions of gambling frequency and expenditure for the typical college student (perceived norms). Gambling expenditure was calculated as the expenditure subscale mean residualized on disposable income.
Gambling Frequency (SOGS)
Time frame: 6 Months
The SOGS was modified to assess internet gambling frequency and expand gambling frequency response options from a three- to a five-point scale with anchors of no times, one to 10 times, more than 10 times, less than weekly, weekly or more than weekly but less than daily, and daily. This modified frequency scale has been shown to correlate highly with other measures of gambling frequency.
Gambling Problems Index (GPI)
Time frame: 6 Months
Gambling problems (or negative consequences) were assessed using the 20-item Gambling Problems Index (GPI). Participants indicated how often, from never to more than 10 times in the past 6 months, they experienced consequences while, or as a result of, gambling.
National Opinion Research Center DSM-IV Screen for Pathological Gambling (NODS)
Time frame: 6 Months
DSM-IV [1] criteria for pathological gambling were assessed using the 17-item National Opinion Research Center DSM-IV Screen (NODS). Some criteria have multiple items, but possible scores range from 0-10 DSM-IV criteria endorsed in the past 6 months.
1 secondary outcome
Illusions of Control
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Results publication: PubMed 22188239Larimer ME, Neighbors C, Lostutter TW, Whiteside U, Cronce JM, Kaysen D, Walker DD. Brief motivational feedback and cognitive behavioral interventions for prevention of disordered gambling: a randomized clinical trial. Addiction. 2012 Jun;107(6):1148-58. doi: 10.1111/j.1360-0443.2011.03776.x. Epub 2012 Feb 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E Larimer, Ph.D principal investigator
University of Washington, Dept of Psychiatry & Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Personalized Feedback Intervention and Cognitive Behavioral Intervention in people with Gambling and Pathological Gambling, run by University of Washington 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 2 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 11 Dec 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
South Oaks Gambling Screen (SOGS) (time frame: 6-Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00078273, which also lists 1 linked publication.
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 11 Dec 2013.