The Effect of a Brief Intervention for Problem Gamblers

Study Overview
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Brief Summary
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A pragmatic randomized pilot trial primarily examining the feasibility of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT). Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.

Detailed Description
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The current study is a pragmatic randomized pilot trial examining the feasibility and effects of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT) . Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT. Participants will be recruited via the Swedish national gambling helpline. After assessment for eligibility participants will be randomized, using block randomization to ensure balanced groups, to either TAU or TAU+CBT. The participants will be measured; at baseline, weekly during the intervention (6 weeks), immediately after the intervention and at 6 weeks after treatment termination. Informed consent will be collected prior any data collection.

Official Title
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The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled

Conditions
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Gambling Problem

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy (CBT)
* Behavioral: Regular help-line telephone counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years Experiencing gambling problems (PGSI ≥ 3 p) Good enough knowledge in Swedish Access to a smart phone or computer with internet connection Exclusion Criteria: Being involved in another treatment study the previous 3 months Other concurrent treatment for gambling problems Being on a non-stable pharmacological treatment for any psychiatric condition Severe depression defined as a PHQ-9 score of 20 points or more

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>The TAU condition consists of a single session of regular help-line telephone counselling | Behavioral: Regular help-line telephone counselling<br>* A single session of telephone counselling with a help-line counsellor<br>|
| Experimental: Cognitive behavioral therapy<br>The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions. | Behavioral: Cognitive behavioral therapy (CBT)<br>* A brief 4 sessions online CBT program with therapist support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention at the end of the study | Retention, defined as proportion of participants who fill out the last follow-up survey | 6-weeks after the intervention | 
| Time for execution of the study | Time for execution of the study as measured by the time from the first included participant to the last included, | from the date of the first included participant to the last included, assessed up to 52 weeks | 
| Participant rated satisfaction with the treatment protocol | Participant rated satisfaction with the treatment protocol will be measured using three items at the end of each online treatment module. The items are measured on a VAS scale ranging from 1-5 (1= not at all, 5 = very). Item 1) How helpful do you think the content of this module has been? Item 2) How well does the content of the module fit the problems you experience and want help with? Item 3) What grade from 1 to 5 would you give this module? | measured in conjunction with each online treatment module for up to six weeks (at four occasions) | 
| Participant rated satisfaction with the treatment at large | Participant rated satisfaction with the treatment at large will be measured immediately after the intervention using 12 items on a VAS scale ranging from 1 (not at all) to 10 (very). Item 8 answers yes or no and item 9 is a free-text entry only available if item 8 answers yes. Items 1- 4 and items 10-12 captures satisfaction with the program and items 5 - 9 captures satisfaction with the therapist. | immediately after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeline follow-back, days gambling and net losses due to gambling | A calendar function where gamblers registers days gambling and nett losses due to gambling. | At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up | 
| Problem Gambling Severity Index (PGSI) | An instrument measuring level of gambling problems using 9 items on a 4 levels Likert-scale, 0 p (never) to 3 p (always), with a total score ranging from 0 to 27 p. Scoring 5 points or more indicates problem gambling. | At baseline and at the 6-weeks follow-up | 
| National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS) | An instrument measuring measuring gambling disorder. The instrument consists of 17 items which are market yes or no and yields a total score of 10 points. Five points or more indicates a pathological gambler. | At baseline, immediately after the intervention and at the 6-weeks follow-up | 
| Alcohol Use Disorders Identification Consumption (AUDIT-C) | An instrument which measures alcohol consumption in the general population. The instrument consists of 3 questions ranging from 0 to 4 with a total score of 0-12 points. A total score of ≥ 6 p indicates alcohol problems in men and ≥ 4 p in women | At baseline, immediately after the intervention and at the 6-weeks follow-up | 
| Drug Use Disorders Identification Test Consumption (DUDIT-C) | An instrument consisting of 3 items measuring illicit drug consumption. | At baseline, immediately after the intervention and at the 6-weeks follow-up | 
| Generalised Anxiety Disorder 7-item scale (GAD-7) | An instrument measuring anxiety consisting of 7 items with a total score ranging from 0 to 21 points where 15 or more points indicates severe anxiety. | At baseline, immediately after the intervention and at the 6-weeks follow-up | 
| Gambling Abstinence Self-Efficacy Scale (GASS) | An instrument measuring self efficacy in gambling situations. The instrument consists of 21 items scored 0 to 5 points, yielding a total score of 0 - 105 points. | At baseline, immediately after the intervention and at the 6-weeks follow-up | 
| Gambling Urges Scale (GUS) | An instrument measuring gambling urges. The instrument consists of 6 items on a Likert-scale 0 to 7, yielding a total score ranging from 0 - 42 points. A higher total score indicates more gambling urges. | At baseline, immediately after the intervention and at the 6-weeks follow-up | 
| Consumption Screen for Problematic Gambling (CSPG) | An instrument measuring consumption of gambling the previous year. The instrument consists of three items yielding a total score ranging from 0-13 points. Four or more points indicates gambling problems | At baseline | 
| Patient Health Questionnaire-9 (PHQ-9) | A nine items instrument measuring depression ranging from 0 to 27 points. Twenty points or more indicates severe depression | At baseline, immediately after the intervention and at the 6-weeks follow-up | 
| World Health Organization Quality of Life Instruments (WHOQOL-BREF) | A 26 items instrument developed by the World Health Organisation measuring quality of life. Items are scored 1-5 points, yielding a total score ranging from 26 - 130 p. | At baseline, immediately after the intervention and at the 6-weeks follow-up |