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Internet Based Cognitive Behavior Therapy for Concerned Significant Others of Problem Gamblers

Primary Purpose

Gambling

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CBT-CSO
Sponsored by
Stockholm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • The CSO and the gambler are at least 18 years old,
  • The CSO is a parent, child, sibling, friend or partner of the gambler.
  • The CSO must have had a relationship with the gambler for at least 3 months.
  • Neither the CSO nor the gambler has had any treatment in the past 3 months (that is related to gambling).
  • The gambler is currently refusing help.
  • The CSO is able to read and answer questions in Swedish, and is willing to talk to a counselor each week.
  • The gambler is a problem gambler according to Problem Gambling Severity Index, as rated by the CSO.
  • The CSO must agree to have their telephone calls recorded.

Exclusion Criteria:

  • Presence of psychotic- or bipolar disorder in the CSO or gambler.
  • CSO meets PGSI criteria for ongoing problem gambling.

Sites / Locations

  • Stockholm University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT-CSO

Wait-list

Arm Description

The CBT-CSO program will be based on concepts from cognitive-behavioral therapy and motivational interviewing, and is specifically developed for use with CSOs of treatment refusing problem gamblers. The program resembles the community reinforcement and family training approach that has been successfully used with CSOs of substance abusers. The program will be given as guided self-help with guidance given via email and telephone. There are 8 modules, which all contain homework exercises and about 5-10 pages of text.

The participants allocated to the control condition will be put on a waiting list and offered the CBT-CSO program after 10 weeks. The CSOs will receive information about available treatment options-in their area and web-based-for the problem gambler.

Outcomes

Primary Outcome Measures

Inventory of Consequences Scale for the Gambler and CSO

Secondary Outcome Measures

9-item Patient Health Questionnaire (PHQ-9)
The Generalised Anxiety Disorder 7-item (GAD-7)
Relationship Assessment Scale (generic version)
WHO Quality of Life Questionnaire-Bref
Timeline followback method
CSOs will be asked to report the amount of money spent on gambling by the identified problem gambler.
Treatment engagement
CSO will be asked to report if and when the identified problem gambler enter treatment. "Entering treatment" is defined as attending at least 1 session or calling the National Gambling Helpline

Full Information

First Posted
September 18, 2014
Last Updated
February 15, 2021
Sponsor
Stockholm University
Collaborators
Karolinska Institutet, Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT02250586
Brief Title
Internet Based Cognitive Behavior Therapy for Concerned Significant Others of Problem Gamblers
Official Title
Internet Based Cognitive-behavioral Therapy for Concerned Significant Others of Problem Gamblers: a Randomized Wait-list Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
August 20, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can have devastating effects on the economy, health and relationship, both for the problem gambler and their concerned significant other (CSO). No empirically supported program exists for the CSOs of problem gamblers. Consequently, the aim of this study is to develop and evaluate a program aimed at CSOs of treatment refusing problem gamblers. The program will be based on principles from cognitive behavioral therapy and motivational interviewing. In order to benefit as many CSOs as possible, the program will be delivered via the Internet with therapist support via email and telephone. METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules over 10 weeks in a secure online environment, and receive support via text messages and over telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at baseline 3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating the PG to seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety, relationship satisfaction and quality of life. HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a reduction in gambling related harm experienced by the CSO, 2) the CBT-CSO program will reduce the CSO's anxiety and depressive feelings, 3) the CBT-CSO program will decrease the amount of time and money the problem gambler spend on gambling, 4) the CBT-CSO program will increase the CSO's relationship satisfaction with the problem gambler.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
CBT-CSO
Arm Type
Experimental
Arm Description
The CBT-CSO program will be based on concepts from cognitive-behavioral therapy and motivational interviewing, and is specifically developed for use with CSOs of treatment refusing problem gamblers. The program resembles the community reinforcement and family training approach that has been successfully used with CSOs of substance abusers. The program will be given as guided self-help with guidance given via email and telephone. There are 8 modules, which all contain homework exercises and about 5-10 pages of text.
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
The participants allocated to the control condition will be put on a waiting list and offered the CBT-CSO program after 10 weeks. The CSOs will receive information about available treatment options-in their area and web-based-for the problem gambler.
Intervention Type
Behavioral
Intervention Name(s)
CBT-CSO
Intervention Description
Internet-delivered cognitive-behavioral therapy for CSO's of treatment refusing problem gamblers
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
The Generalised 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.
Title
Relationship Assessment Scale (generic version)
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
WHO Quality of Life Questionnaire-Bref
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
Timeline followback method
Description
CSOs will be asked to report the amount of money spent on gambling by the identified 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.
Title
Treatment engagement
Description
CSO will be asked to report if and when the identified problem gambler enter treatment. "Entering treatment" is defined as attending at least 1 session or calling the National Gambling Helpline
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 and the gambler are at least 18 years old, The CSO is a parent, child, sibling, friend or partner of the gambler. The CSO must have had a relationship with the gambler for at least 3 months. Neither the CSO nor the gambler has had any treatment in the past 3 months (that is related to gambling). The gambler is currently refusing help. The CSO is able to read and answer questions in Swedish, and is willing to talk to a counselor each week. The gambler is a problem gambler according to Problem Gambling Severity Index, as rated by the CSO. The CSO must agree to have their telephone calls recorded. Exclusion Criteria: Presence of psychotic- or bipolar disorder in the CSO or gambler. CSO meets PGSI criteria for ongoing problem gambling.
Facility Information:
Facility Name
Stockholm University
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26656017
Citation
Magnusson K, Nilsson A, Hellner Gumpert C, Andersson G, Carlbring P. Internet-delivered cognitive-behavioural therapy for concerned significant others of people with problem gambling: study protocol for a randomised wait-list controlled trial. BMJ Open. 2015 Dec 9;5(12):e008724. doi: 10.1136/bmjopen-2015-008724.
Results Reference
background
PubMed Identifier
31403816
Citation
Magnusson K, Nilsson A, Andersson G, Hellner C, Carlbring P. Internet-delivered cognitive-behavioral therapy for significant others of treatment-refusing problem gamblers: A randomized wait-list controlled trial. J Consult Clin Psychol. 2019 Sep;87(9):802-814. doi: 10.1037/ccp0000425.
Results Reference
result
Links:
URL
https://spel.iterapi.se
Description
Public website to convey study information and recruitment
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://osf.io
Available IPD/Information Identifier
awtg7
Available IPD/Information Comments
The trial's outcome data and scripts are available for download: https://osf.io/awtg7/

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Internet Based Cognitive Behavior Therapy for Concerned Significant Others of Problem Gamblers

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