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

Study Overview
=================
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.

Official Title
-----------------
Internet-Delivered Treatments for Pathological Gambling: a Randomized Controlled Trial Comparing the Effects of Added Involvement By Concerned Significant Others

Conditions
-----------------
Gambling

Intervention / Treatment
-----------------
* Behavioral: Behavioral Couples Therapy (BCT)
* Behavioral: Cognitive Behavioral Therapy (CBT)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Couples Therapy<br>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)<br>* 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.<br>|
| Active Comparator: Cognitive Behavioral Therapy<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 
| National Opinion Research Center DSM-IV Screen for Gambling Problems (NODS) | Measures consequences of gambling, as rated by the 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9-item Patient Health Questionnaire (PHQ-9) | Screening for depressive symptoms, as rated individually by the gambler and the CSO. | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 
| The Generalized Anxiety Disorder 7-item (GAD-7) | Screening for anxiety, as rated individually by the gambler and the CSO. | 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) (RAS-G) | Measures relationship satisfaction, as rated individually by the gambler and the CSO. | 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. | 
| Inventory of Consequences Scale for the Gambler and CSO | Measures consequences of gambling, as rated individually by the gambler and the CSO. | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 
| The Alcohol Use Disorders Identification Test (AUDIT) | Measures alcohol consumption, as rated individually by the gambler and the CSO. | Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period. | 
| Dissociative Experiences while Gambling | Measures dissociative experiences while gambling, as rated by the gambler. | 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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
concerned significant other, problem gambling, internet-delivered cognitive-behavioral therapy, behavioral couples therapy