- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03946098
ICBTG in Routine Care (iCBTG)
December 11, 2021 updated by: Anne H Berman, Karolinska Institutet
Implementation of Internet-based Cognitive Behavior Therapy for Problem Gambling in Routine Addiction Care: A Feasibility Study
Problem gambling (PG) is a major public health concern worldwide.
As awareness of PG has risen, treatment demand is increasing, and internet interventions is a promising alternative for providing fast, evidence-based treatment at scale, to a low cost.
This article presents the protocol of an open label, uncontrolled pilot and feasibility trial of a novel internet-delivered cognitive behavioral treatment, conducted in regular addiction care with adult treatment-seeking patients (max N=25) with problematic gambling.
Weekly measures of gambling symptoms and gambling will serve as outcome measures.
Study results will further guide the development of the intervention and its implementation into regular addiction care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden, 117 61
- eStöd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- being at least 18 years old
- living in Sweden
- being able to read and write Swedish.
- having a total score of >= 3 on the Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001)
- having the ability to work with online treatment material by themselves (with support from a therapist)
Exclusion criteria:
- fulfilling criteria for ongoing manic episode
- currently undergoing a parallel CBT treatment for Gambling Disorder or problem gambling.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: iCBT for Gambling Disorder
Treatment will consist of a 1+10 module internet delivered CBT program targeting problem gambling, newly developed.
A bottom-up procedure was used to develop the treatment protocol, inspired by Clark's (2004) method for developing novel CBT treatments.
We developed a clinical model delineating what factors contribute to the persistence of problem gambling behavior, and aligned these with targeted treatment interventions; based on behavioral upon research on the learning and maintenance processes of gambling behavior (Ramnerö et al, in press), theoretical models of gambling and comorbidity (Blaszczynski & Nower, 2002); as well as qualitative interviews with treatment seeking gamblers with or without comorbidity.
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A newly developed iCBT protocol targeting problem gambling.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Gambling Symptom Assessment Scale (G-SAS)
Time Frame: Past 7 days
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Gambling symptoms
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Past 7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Gambling Time Line Follow Back (TLFB-G)
Time Frame: Past 7 days
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Gambling behavior
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Past 7 days
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The 9-item Patient Health Questionnaire (PHQ-9
Time Frame: Past 2 weeks
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Depressive symptoms
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Past 2 weeks
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The 7-item Generalised Anxiety Disorder scale (GAD-7)
Time Frame: Past 2 weeks
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Anxiety symptoms
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Past 2 weeks
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The Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: Past 12 months
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Alcohol use
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Past 12 months
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The Drug Use Disorders Identification Test (DUDIT)
Time Frame: Past 12 months
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Drug use
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Past 12 months
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the 26-item World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time Frame: Past 2 weeks
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Quality of life
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Past 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Philip H Lindner, PhD, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 4, 2019
Primary Completion (ACTUAL)
February 9, 2021
Study Completion (ACTUAL)
February 9, 2021
Study Registration Dates
First Submitted
April 28, 2019
First Submitted That Met QC Criteria
May 9, 2019
First Posted (ACTUAL)
May 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 3, 2022
Last Update Submitted That Met QC Criteria
December 11, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0428
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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