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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00078273
Other study ID # 23848-C
Secondary ID R21MH067026DATR
Status Completed
Phase Phase 2
First received February 20, 2004
Last updated December 10, 2013
Start date July 2003
Est. completion date July 2003

Study information

Verified date December 2013
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date July 2003
Est. primary completion date July 2003
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 24 Years
Eligibility Inclusion Criteria:

- College student

- South Oaks Gambling Screen (SOGS) score greater than 3

Exclusion Criteria:

- None, other than not meeting inclusion criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Personalized Feedback Intervention
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 Intervention
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.

Locations

Country Name City State
United States University of Washington; Department of Psychiatry and Behavioral Sciences Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6-Months No
Primary 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. 6 Months No
Primary 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. 6 Months No
Primary 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. 6 Months No
Primary 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. 6 Months No
Secondary 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. 6 Months No
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