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Clinical Trials/NCT02543372
NCT02543372
Completed
Not Applicable

Internet-Delivered Treatments for Pathological Gambling: a Randomized Controlled Trial Comparing the Effects of Added Involvement By Concerned Significant Others

Karolinska Institutet1 site in 1 country260 target enrollmentAugust 2015
ConditionsGambling

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gambling
Sponsor
Karolinska Institutet
Enrollment
260
Locations
1
Primary Endpoint
Gambling-Timelime Follow-Back (G-TLFB)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Background: Problem gambling is a public health concern with prevalence rates at 2 %. Problem gambling also severely affects concerned significant others (CSOs). Several studies have investigated the effects of individual treatments based on cognitive behavior therapy (CBT), but there is a shortage in studies on the effect of involving CSOs in treatment. This study aims to compare an intervention based on behavioral couples therapy (BCT) involving a CSO with an individual CBT treatment to determine their relative efficacy. BCT has shown promising results in working with substance abuse, but this is the first time it is used as an intervention for problem gambling. Both interventions will be Internet-delivered and participants will receive e-mail and telephone support.

Method/Design: A sample of at least 100 couples will be randomized to either the BCT condition or the CBT condition. The participants will work through 10 modules over 12 weeks in a secure online environment, and receive support via email and over telephone. Repeated measures will be conducted weekly and at 3, 6 and 12 months follow-up. The primary outcome measure is gambling behavior, defined as time spent and money lost on gambling, as measured by timeline follow-back. Secondary outcomes include gambling related harm, alcohol consumption, relationship satisfaction and mental health for the gambler as well as for the CSO.

Hypotheses: The investigators hypothesize that a) BCT will yield greater reductions on gambling measures than CBT, b) BCT will yield a lower drop-out rate compared to CBT, c) BCT will be superior to CBT on increasing relationship satisfaction, d) relationship functioning will mediate change in gambling behavior in the BCT group and e) reduction in gambling behavior will mediate change in relationship functioning in the CBT group.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
June 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Clara Hellner Gumpert

MD/PhD

Karolinska Institutet

Eligibility Criteria

Inclusion Criteria

  • The CSO is a parent, child, sibling, friend or partner of the gambler.
  • Participants are at least 18 years old.
  • The gambler is a problem gambler according to Problem Gambling Severity Index.
  • Participants must have had a relationship with the gambler for at least 3 months.
  • Participants must be able to read and answer questions in Swedish, and is willing to be in contact with a counselor each week.
  • Participants must have access to internet.

Exclusion Criteria

  • Participants are currently in any other treatment related to problem gambling.
  • The CSO is a problem gambler according to Problem Gambling Severity Index.
  • Participants displaying symptoms of severe psychiatric disorders, such as psychotic- or bipolar disorders, judged to require further treatment.

Outcomes

Primary Outcomes

Gambling-Timelime Follow-Back (G-TLFB)

Time Frame: Change from baseline at: [1] weekly during treatment;[2] end of treatment period; follow-ups at [3] month 6 and [4] month 12 after the treatment period.

Measures money and time spent on gambling by the gambler, as rated individually by the gambler and the CSO.

National Opinion Research Center DSM-IV Screen for Gambling Problems (NODS)

Time Frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

Measures consequences of gambling, as rated by the problem gambler.

Secondary Outcomes

  • The Generalized Anxiety Disorder 7-item (GAD-7)(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • Relationship Assessment Scale (generic version) (RAS-G)(Change from baseline at: [1] weekly during treatment;[2] end of treatment period; follow-ups at [3] month 6 and [4] month 12 after the treatment period.)
  • Inventory of Consequences Scale for the Gambler and CSO(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • Dissociative Experiences while Gambling(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • 9-item Patient Health Questionnaire (PHQ-9)(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)
  • The Alcohol Use Disorders Identification Test (AUDIT)(Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.)

Study Sites (1)

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