ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02543372
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : September 3, 2018
Sponsor:
Collaborators:
Stockholm University
Linkoeping University
Information provided by (Responsible Party):
Clara Hellner Gumpert, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Gambling Behavioral: Behavioral Couples Therapy (BCT) Behavioral: Cognitive Behavioral Therapy (CBT) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-Delivered Treatments for Pathological Gambling: a Randomized Controlled Trial Comparing the Effects of Added Involvement By Concerned Significant Others
Study Start Date : August 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543372


Locations
Sweden
Karolinska Institutet
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Karolinska Institutet
Stockholm University
Linkoeping University
Investigators
Principal Investigator: Clara Hellner Gumpert, MD/PhD Karolinska Institutet

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clara Hellner Gumpert, MD/PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02543372     History of Changes
Other Study ID Numbers: 2014/175-31/5
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

Keywords provided by Clara Hellner Gumpert, Karolinska Institutet:
concerned significant other
problem gambling
internet-delivered cognitive-behavioral therapy
behavioral couples therapy

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders