The Effect of a Brief Intervention for Problem Gamblers

Not Applicable

Completed

• Conditions: Gambling Problem
• Interventions: Behavioral: Regular help-line telephone counselling; Behavioral: Cognitive behavioral therapy (CBT)

• Registration Number: NCT04609007
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2018-08-30
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-23
• Last Update Submitted: 2020-10-23
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Regular help-line telephone counselling	The TAU condition consists of a single session of regular help-line telephone counselling
Cognitive behavioral therapy	Cognitive behavioral therapy (CBT)	The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions.

Primary Outcome Measures

Name	Time	Method
Participant rated satisfaction with the treatment at large	immediately after the intervention.	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.
Participant rated satisfaction with the treatment protocol	measured in conjunction with each online treatment module for up to six weeks (at four occasions)	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?
Retention at the end of the study	6-weeks after the intervention	Retention, defined as proportion of participants who fill out the last follow-up survey
Time for execution of the study	from the date of the first included participant to the last included, assessed up to 52 weeks	Time for execution of the study as measured by the time from the first included participant to the last included,

Secondary Outcome Measures

Name	Time	Method
Timeline follow-back, days gambling and net losses due to gambling	At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up	A calendar function where gamblers registers days gambling and nett losses due to gambling.
Problem Gambling Severity Index (PGSI)	At baseline and at the 6-weeks follow-up	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.
National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)	At baseline, immediately after the intervention and at the 6-weeks follow-up	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.
Drug Use Disorders Identification Test Consumption (DUDIT-C)	At baseline, immediately after the intervention and at the 6-weeks follow-up	An instrument consisting of 3 items measuring illicit drug consumption.
Generalised Anxiety Disorder 7-item scale (GAD-7)	At baseline, immediately after the intervention and at the 6-weeks follow-up	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.
Alcohol Use Disorders Identification Consumption (AUDIT-C)	At baseline, immediately after the intervention and at the 6-weeks follow-up	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
Consumption Screen for Problematic Gambling (CSPG)	At baseline	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
Patient Health Questionnaire-9 (PHQ-9)	At baseline, immediately after the intervention and at the 6-weeks follow-up	A nine items instrument measuring depression ranging from 0 to 27 points. Twenty points or more indicates severe depression
Gambling Abstinence Self-Efficacy Scale (GASS)	At baseline, immediately after the intervention and at the 6-weeks follow-up	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.
World Health Organization Quality of Life Instruments (WHOQOL-BREF)	At baseline, immediately after the intervention and at the 6-weeks follow-up	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.
Gambling Urges Scale (GUS)	At baseline, immediately after the intervention and at the 6-weeks follow-up	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.

Trial Locations

Locations (1)

Stockholm Center for Psychiatry Research; 🇸🇪 Stockholm, Sweden