- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04609007
The Effect of a Brief Intervention for Problem Gamblers
The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 11364
- Stockholm Center for Psychiatry Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as usual
The TAU condition consists of a single session of regular help-line telephone counselling
|
A single session of telephone counselling with a help-line counsellor
|
Experimental: Cognitive behavioral therapy
The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions.
|
A brief 4 sessions online CBT program with therapist support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention at the end of the study
Time Frame: 6-weeks after the intervention
|
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 Frame: 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,
|
from the date of the first included participant to the last included, assessed up to 52 weeks
|
Participant rated satisfaction with the treatment protocol
Time Frame: 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? |
measured in conjunction with each online treatment module for up to six weeks (at four occasions)
|
Participant rated satisfaction with the treatment at large
Time Frame: 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.
|
immediately after the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timeline follow-back, days gambling and net losses due to gambling
Time Frame: 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.
|
At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up
|
Problem Gambling Severity Index (PGSI)
Time Frame: 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.
|
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)
Time Frame: 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.
|
At baseline, immediately after the intervention and at the 6-weeks follow-up
|
Alcohol Use Disorders Identification Consumption (AUDIT-C)
Time Frame: 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
|
At baseline, immediately after the intervention and at the 6-weeks follow-up
|
Drug Use Disorders Identification Test Consumption (DUDIT-C)
Time Frame: At baseline, immediately after the intervention and at the 6-weeks follow-up
|
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)
Time Frame: 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.
|
At baseline, immediately after the intervention and at the 6-weeks follow-up
|
Gambling Abstinence Self-Efficacy Scale (GASS)
Time Frame: 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.
|
At baseline, immediately after the intervention and at the 6-weeks follow-up
|
Gambling Urges Scale (GUS)
Time Frame: 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.
|
At baseline, immediately after the intervention and at the 6-weeks follow-up
|
Consumption Screen for Problematic Gambling (CSPG)
Time Frame: 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
|
At baseline
|
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 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
|
At baseline, immediately after the intervention and at the 6-weeks follow-up
|
World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Time Frame: 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.
|
At baseline, immediately after the intervention and at the 6-weeks follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Clara Hellner, Professor, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1063-31
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gambling Problem
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedGambling | Pathological Gambling | Problem GamblingUnited States
-
Université Catholique de LouvainCentre Hospitalier Universitaire Vaudois; Cliniques universitaires Saint-Luc-... and other collaboratorsUnknownCraving | Gambling | Gambling Disorder | Gambling, Pathological | Gambling ProblemSwitzerland
-
Karolinska InstitutetCompleted
-
Region SkaneLund UniversityRecruitingGambling Disorder | Problem GamblingSweden
-
Universitat Jaume INot yet recruitingGambling Disorder | Problem GamblingSpain
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingAccelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial (arTMSinGD)Gambling | Gambling Disorder | Gambling, Pathological | Gambling Problem
-
Karolinska InstitutetThe National Gambling Helpline SwedenNot yet recruiting
-
King's College LondonCompleted
-
Cambridge Health AllianceInternational Center for Responsible Gaming; Hoosier Lottery, IndianaNot yet recruiting
-
University of Maryland, BaltimoreNational Center for Responsible GamingCompletedGambling ProblemUnited States
Clinical Trials on Regular help-line telephone counselling
-
University of Southern DenmarkDanish Cancer Society; National Board of Health, DenmarkUnknownSmoking | Smoking Cessation | Self-efficacyDenmark
-
University of AlbertaCompletedLymphoma | Lymphoma, Non-Hodgkin | Leukemia | Behavior, HealthCanada
-
Sadir AssociationCompletedSleep Apnea Syndromes
-
National University Hospital, SingaporeCompleted
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); London Health Sciences Centre; H. Lee Moffitt Cancer Center and Research Institute and other collaboratorsUnknownBreast Cancer | Ovarian Cancer | BRCA1 Gene Mutation | BRCA2 Gene MutationCanada
-
Chinese University of Hong KongCompleted
-
University of LincolnNottingham University Hospitals NHS TrustCompletedDepression | End-stage Renal DiseaseUnited Kingdom
-
University of NottinghamUnknownCarer Stress SyndromeUnited Kingdom
-
University of California, San DiegoPartnership for Smoke-Free Families (PSF)Completed
-
University of California, San DiegoNational Institute of Mental Health (NIMH)CompletedAnxiety Disorders | Generalized Anxiety Disorder | Social Anxiety Disorder | Separation Anxiety Disorder | Specific PhobiaUnited States