Clinical trial NCT02543372: RCT of Internet-Delivered CBT Treatments for Pathological Gambling: Comparing the Effects of Added Involvement From CSOs
Official title: Internet-Delivered Treatments for Pathological Gambling: a Randomized Controlled Trial Comparing the Effects of Added Involvement By Concerned Significant Others
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling
Keywords: concerned significant other
problem gambling
internet-delivered cognitive-behavioral therapy
behavioral couples therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm University
name: Linkoeping University
First posted: 2015-09-07
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Gambling-Timelime Follow-Back (G-TLFB)
timeFrame: 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.
measure: National Opinion Research Center DSM-IV Screen for Gambling Problems (NODS)
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Secondary outcomes:
measure: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: The Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: Relationship Assessment Scale (generic version) (RAS-G)
timeFrame: 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.
measure: Inventory of Consequences Scale for the Gambler and CSO
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: The Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: Dissociative Experiences while Gambling
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Clara Hellner Gumpert, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson A, Magnusson K, Carlbring P, Andersson G, Hellner Gumpert C. Effects of added involvement from concerned significant others in internet-delivered CBT treatments for problem gambling: study protocol for a randomised controlled trial. BMJ Open. 2016 Sep 26;6(9):e011974. doi: 10.1136/bmjopen-2016-011974.