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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.

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

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
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

Other trials in United States

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.

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 groups in NCT00078273
Study groupRoleWhat they receive
Assessment Only ControlNo interventionCompleted Baseline and 6 month follow-up surveys only.
Personalized Feedback InterventionExperimentalSee Intervention Description
Receives: Behavioral: Personalized Feedback Intervention
Cognitive Behavioral InterventionExperimentalSee Intervention Description
Receives: Behavioral: Cognitive Behavioral Intervention

What is being measured

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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)
  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.

  1. First posted24 Feb 2004 (estimated)
  2. Study startJul 2003
  3. Primary completionJul 2003
  4. Study completionJul 2003

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
225 participants (actual)
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

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.

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