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

Study Overview
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Brief Summary
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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.

Official Title
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Internet Based Cognitive-behavioral Therapy for Concerned Significant Others of Problem Gamblers: a Randomized Wait-list Controlled Trial

Conditions
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Gambling

Intervention / Treatment
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* Behavioral: CBT-CSO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-CSO<br>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. | Behavioral: CBT-CSO<br>* Internet-delivered cognitive-behavioral therapy for CSO's of treatment refusing problem gamblers<br>|
| No Intervention: Wait-list<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inventory of Consequences Scale for the Gambler and CSO |  | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9-item Patient Health Questionnaire (PHQ-9) |  | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 
| The Generalised Anxiety Disorder 7-item (GAD-7) |  | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 
| Relationship Assessment Scale (generic version) |  | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 
| WHO Quality of Life Questionnaire-Bref |  | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 
| Timeline followback method | CSOs will be asked to report the amount of money spent on gambling by the identified problem gambler. | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 
| 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 | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concerned significant other, internet-delivered cognitive-behavioral therapy,, treatment-refusing problem gambler