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

Primary Purpose

Gambling

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Behavioral Couples Therapy (BCT)
Cognitive Behavioral Therapy (CBT)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling focused on measuring concerned significant other, problem gambling, internet-delivered cognitive-behavioral therapy, behavioral couples therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Couples Therapy

Cognitive Behavioral Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gambling-Timelime Follow-Back (G-TLFB)
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)
Measures consequences of gambling, as rated by the problem gambler.

Secondary Outcome Measures

9-item Patient Health Questionnaire (PHQ-9)
Screening for depressive symptoms, as rated individually by the gambler and the CSO.
The Generalized Anxiety Disorder 7-item (GAD-7)
Screening for anxiety, as rated individually by the gambler and the CSO.
Relationship Assessment Scale (generic version) (RAS-G)
Measures relationship satisfaction, as rated individually by the gambler and the CSO.
Inventory of Consequences Scale for the Gambler and CSO
Measures consequences of gambling, as rated individually by the gambler and the CSO.
The Alcohol Use Disorders Identification Test (AUDIT)
Measures alcohol consumption, as rated individually by the gambler and the CSO.
Dissociative Experiences while Gambling
Measures dissociative experiences while gambling, as rated by the gambler.

Full Information

First Posted
September 3, 2015
Last Updated
August 30, 2018
Sponsor
Karolinska Institutet
Collaborators
Stockholm University, Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT02543372
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm University, Linkoeping University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling
Keywords
concerned significant other, problem gambling, internet-delivered cognitive-behavioral therapy, behavioral couples therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Couples Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Couples Therapy (BCT)
Intervention Description
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
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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 Measure Information:
Title
Gambling-Timelime Follow-Back (G-TLFB)
Description
Measures money and time spent on gambling by the gambler, as rated individually by the gambler and the CSO.
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.
Title
National Opinion Research Center DSM-IV Screen for Gambling Problems (NODS)
Description
Measures consequences of gambling, as rated by the problem gambler.
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.
Secondary Outcome Measure Information:
Title
9-item Patient Health Questionnaire (PHQ-9)
Description
Screening for depressive symptoms, as rated individually by the gambler and the 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.
Title
The Generalized Anxiety Disorder 7-item (GAD-7)
Description
Screening for anxiety, as rated individually by the gambler and the 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.
Title
Relationship Assessment Scale (generic version) (RAS-G)
Description
Measures relationship satisfaction, as rated individually by the gambler and the CSO.
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.
Title
Inventory of Consequences Scale for the Gambler and CSO
Description
Measures consequences of gambling, as rated individually by the gambler and the 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.
Title
The Alcohol Use Disorders Identification Test (AUDIT)
Description
Measures alcohol consumption, as rated individually by the gambler and the 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.
Title
Dissociative Experiences while Gambling
Description
Measures dissociative experiences while gambling, as rated by the gambler.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Hellner Gumpert, MD/PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27670519
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.
Results Reference
derived
Links:
URL
http://www.spelfri.se
Description
Public website to convey study information and recruitment

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

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