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

NCT ID: NCT02543372

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-06-30

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.

Conditions

Gambling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Couples Therapy

The participants receive 10 modules each containing treatment focusing on gambling and relationship functioning. The modules consist of text, videos, images and assignments. The participants receive support from an assigned therapist via email and telephone. Both the gamblers and the CSOs receive 10 modules each.

Group Type: EXPERIMENTAL

Behavioral Couples Therapy (BCT)

Intervention Type: 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

The participants receive 10 modules each containing treatment focusing on gambling and relationship functioning. The modules consist of text, videos, images and assignments. The participants receive support from an assigned therapist via email and telephone. The gamblers receive 10 modules, but the CSOs do not receive any modules.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type: 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.

Interventions

Behavioral Couples Therapy (BCT)

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.

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stockholm University

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Clara Hellner Gumpert

MD/PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clara Hellner Gumpert, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 27670519 (View on PubMed)

Related Links

http://www.spelfri.se

Public website to convey study information and recruitment

Other Identifiers

2014/175-31/5

Identifier Type: -

Identifier Source: org_study_id