Problem GamblingiCBTGNCT03946098
ICBTG in Routine Care
A study testing iCBT in people with Problem Gambling and Gambling Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem Gambling, Gambling Disorder
- What is being tested?
- iCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- 4 Oct 2019to 9 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- fulfilling criteria for ongoing manic episode
- currently undergoing a parallel CBT treatment for Gambling Disorder or problem gambling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Problem Gambling, Gambling Disorder
- Being tested
- iCBT
- Keywords
- Internet intervention, Gambling Disorder, Cognitive-behavioral therapy, Psychiatric comorbidity, Regular addiction care, Problem gambling
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBTBehavioural
A newly developed iCBT protocol targeting problem gambling.
| Study group | Role | What they receive |
|---|---|---|
| iCBT for Gambling Disorder | Experimental | 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. Receives: Behavioral: iCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Gambling Symptom Assessment Scale (G-SAS)
Gambling symptoms
Measured: Past 7 days
Secondary outcomes (6)
The Gambling Time Line Follow Back (TLFB-G)
Gambling behavior
Measured: Past 7 days
The 9-item Patient Health Questionnaire (PHQ-9
Depressive symptoms
Measured: Past 2 weeks
The 7-item Generalised Anxiety Disorder scale (GAD-7)
Anxiety symptoms
Measured: Past 2 weeks
The Alcohol Use Disorders Identification Test (AUDIT)
Alcohol use
Measured: Past 12 months
The Drug Use Disorders Identification Test (DUDIT)
Drug use
Measured: Past 12 months
the 26-item World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Quality of life
Measured: Past 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start4 Oct 2019
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problem GamblingStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne H Berman, Karolinska Institutet
- Investigators
- Philip H Lindner, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946098
- Sponsor's protocol ID
- 2019-0428
- Acronym
- iCBTG
- Status last verified
- Dec 2021
- First submitted
- 28 Apr 2019
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Molander O, Lindner P, Ramnero J, Bjureberg J, Carlbring P, Berman AH. Internet-based cognitive behavior therapy for problem gambling in routine care: protocol for a non-randomized pilot and feasibility trial. Pilot Feasibility Stud. 2020 Jul 21;6:106. doi: 10.1186/s40814-020-00647-5. eCollection 2020.
PubMed 32699645
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Internet-based Cognitive Behavior Therapy for Problem Gambling in Routine Addiction Care: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03946098
- Acronym / sponsor ID
- iCBTG / 2019-0428
- Conditions
- Problem Gambling, Gambling Disorder
- Keywords
- Internet intervention, Gambling Disorder, Cognitive-behavioral therapy, Psychiatric comorbidity, Regular addiction care, Problem gambling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCBT for Gambling Disorder | Experimental | Behavioral: iCBTTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- fulfilling criteria for ongoing manic episode
- currently undergoing a parallel CBT treatment for Gambling Disorder or problem gambling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBTA newly developed iCBT protocol targeting problem gambling. | Behavioural | iCBT for Gambling Disorder |
Primary outcome
The Gambling Symptom Assessment Scale (G-SAS)
Time frame: Past 7 days
Gambling symptoms
6 secondary outcomes
The Gambling Time Line Follow Back (TLFB-G)
Time frame: Past 7 days
The 9-item Patient Health Questionnaire (PHQ-9
Time frame: Past 2 weeks
The 7-item Generalised Anxiety Disorder scale (GAD-7)
Time frame: Past 2 weeks
The Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Past 12 months
The Drug Use Disorders Identification Test (DUDIT)
Time frame: Past 12 months
the 26-item World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: Past 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Derived from this study: PubMed 32699645Molander O, Lindner P, Ramnero J, Bjureberg J, Carlbring P, Berman AH. Internet-based cognitive behavior therapy for problem gambling in routine care: protocol for a non-randomized pilot and feasibility trial. Pilot Feasibility Stud. 2020 Jul 21;6:106. doi: 10.1186/s40814-020-00647-5. eCollection 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip H Lindner, PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT in people with Problem Gambling and Gambling Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Gambling Symptom Assessment Scale (G-SAS) (time frame: Past 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022; AzTrials last refreshed its copy on 27 Oct 2026.