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Completed

NCT Number: NCT02543372

RCT of Internet-Delivered CBT Treatments for Pathological Gambling: Comparing the Effects of Added Involvement From CSOs

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.

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Key information

Conditions

Gambling Behavior Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Risk-Taking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 171 77, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Couples Therapy (BCT)

Behavioral

BCT integrates cognitive behavioral techniques targeting problem gambling with a large focus on interventions for relationship functioning. The BCT condition requires active participation from both the gambler and the CSO.

Cognitive Behavioral Therapy (CBT)

Behavioral

The CBT integrates cognitive behavioral techniques targeting problem gambling with some interventions for relationship functioning.The CBT condition requires active participation from the gambler, but not for the CSO.

Primary outcomes

  1. 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.

  2. 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

  1. 9-item Patient Health Questionnaire (PHQ-9)

    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.

    Screening for depressive symptoms, as rated individually by the gambler and the CSO.

  2. The Generalized Anxiety Disorder 7-item (GAD-7)

    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.

    Screening for anxiety, as rated individually by the gambler and the CSO.

  3. Relationship Assessment Scale (generic version) (RAS-G)

    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 relationship satisfaction, as rated individually by the gambler and the CSO.

  4. Inventory of Consequences Scale for the Gambler and CSO

    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 individually by the gambler and the CSO.

  5. The Alcohol Use Disorders Identification Test (AUDIT)

    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 alcohol consumption, as rated individually by the gambler and the CSO.

  6. Dissociative Experiences while Gambling

    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 dissociative experiences while gambling, as rated by the gambler.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Linkoeping University
  • Stockholm University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2015
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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