The Effect of a Brief Intervention for Problem Gamblers

Gambling Problem Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609007
• Other study ID #: 2017/1063-31
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: March 2015

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gambling
• Gambling Problem

Intervention

Behavioral:
• Cognitive behavioral therapy (CBT)
A brief 4 sessions online CBT program with therapist support.
• Regular help-line telephone counselling
A single session of telephone counselling with a help-line counsellor

Locations

Country	Name	City	State
Sweden	Stockholm Center for Psychiatry Research	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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