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The Effect of a Brief Intervention for Problem Gamblers

Primary Purpose

Gambling Problem

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Regular help-line telephone counselling
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling Problem

Eligibility Criteria

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

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

Sites / Locations

  • Stockholm Center for Psychiatry Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment as usual

Cognitive behavioral therapy

Arm Description

The TAU condition consists of a single session of regular help-line telephone counselling

The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions.

Outcomes

Primary Outcome Measures

Retention at the end of the study
Retention, defined as proportion of participants who fill out the last follow-up survey
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,
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?
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.

Secondary Outcome Measures

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.
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.
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.
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
Drug Use Disorders Identification Test Consumption (DUDIT-C)
An instrument consisting of 3 items measuring illicit drug consumption.
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.
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.
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.
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
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
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.

Full Information

First Posted
August 30, 2018
Last Updated
October 23, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04609007
Brief Title
The Effect of a Brief Intervention for Problem Gamblers
Official Title
The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Problem

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
The TAU condition consists of a single session of regular help-line telephone counselling
Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
A brief 4 sessions online CBT program with therapist support.
Intervention Type
Behavioral
Intervention Name(s)
Regular help-line telephone counselling
Intervention Description
A single session of telephone counselling with a help-line counsellor
Primary Outcome Measure Information:
Title
Retention at the end of the study
Description
Retention, defined as proportion of participants who fill out the last follow-up survey
Time Frame
6-weeks after the intervention
Title
Time for execution of the study
Description
Time for execution of the study as measured by the time from the first included participant to the last included,
Time Frame
from the date of the first included participant to the last included, assessed up to 52 weeks
Title
Participant rated satisfaction with the treatment protocol
Description
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?
Time Frame
measured in conjunction with each online treatment module for up to six weeks (at four occasions)
Title
Participant rated satisfaction with the treatment at large
Description
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.
Time Frame
immediately after the intervention.
Secondary Outcome Measure Information:
Title
Timeline follow-back, days gambling and net losses due to gambling
Description
A calendar function where gamblers registers days gambling and nett losses due to gambling.
Time Frame
At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up
Title
Problem Gambling Severity Index (PGSI)
Description
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.
Time Frame
At baseline and at the 6-weeks follow-up
Title
National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)
Description
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.
Time Frame
At baseline, immediately after the intervention and at the 6-weeks follow-up
Title
Alcohol Use Disorders Identification Consumption (AUDIT-C)
Description
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
Time Frame
At baseline, immediately after the intervention and at the 6-weeks follow-up
Title
Drug Use Disorders Identification Test Consumption (DUDIT-C)
Description
An instrument consisting of 3 items measuring illicit drug consumption.
Time Frame
At baseline, immediately after the intervention and at the 6-weeks follow-up
Title
Generalised Anxiety Disorder 7-item scale (GAD-7)
Description
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.
Time Frame
At baseline, immediately after the intervention and at the 6-weeks follow-up
Title
Gambling Abstinence Self-Efficacy Scale (GASS)
Description
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.
Time Frame
At baseline, immediately after the intervention and at the 6-weeks follow-up
Title
Gambling Urges Scale (GUS)
Description
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.
Time Frame
At baseline, immediately after the intervention and at the 6-weeks follow-up
Title
Consumption Screen for Problematic Gambling (CSPG)
Description
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
Time Frame
At baseline
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
A nine items instrument measuring depression ranging from 0 to 27 points. Twenty points or more indicates severe depression
Time Frame
At baseline, immediately after the intervention and at the 6-weeks follow-up
Title
World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Description
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.
Time Frame
At baseline, immediately after the intervention and at the 6-weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Hellner, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm Center for Psychiatry Research
City
Stockholm
ZIP/Postal Code
11364
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of a Brief Intervention for Problem Gamblers

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