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The Effect of a Brief Intervention for Problem Gamblers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04609007
Enrollment
36
Registered
2020-10-30
Start date
2015-03-31
Completion date
2015-03-31
Last updated
2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gambling Problem

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.

Interventions

BEHAVIORALCognitive behavioral therapy (CBT)

A brief 4 sessions online CBT program with therapist support.

BEHAVIORALRegular help-line telephone counselling

A single session of telephone counselling with a help-line counsellor

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Retention at the end of the study6-weeks after the interventionRetention, defined as proportion of participants who fill out the last follow-up survey
Time for execution of the studyfrom the date of the first included participant to the last included, assessed up to 52 weeksTime 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 protocolmeasured 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?
Participant rated satisfaction with the treatment at largeimmediately 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.

Secondary

MeasureTime frameDescription
Drug Use Disorders Identification Test Consumption (DUDIT-C)At baseline, immediately after the intervention and at the 6-weeks follow-upAn 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-upAn 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)At baseline, immediately after the intervention and at the 6-weeks follow-upAn 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.
Timeline follow-back, days gambling and net losses due to gamblingAt baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-upA calendar function where gamblers registers days gambling and nett losses due to gambling.
Consumption Screen for Problematic Gambling (CSPG)At baselineAn 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-upA 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)At baseline, immediately after the intervention and at the 6-weeks follow-upA 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-upAn 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.
Problem Gambling Severity Index (PGSI)At baseline and at the 6-weeks follow-upAn 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-upAn 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)At baseline, immediately after the intervention and at the 6-weeks follow-upAn 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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026