Gambling DisorderNCT06989125
Internet-based Versus Synchronous Cognitive Behavioural Therapy for Patients With Gambling Disorder
A study testing Internet-based cognitive behavioral therapy and Synchronous cognitive behavioral therapy in people with Gambling Disorder, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The aim of this two-armed, randomized controlled trial is to determine if internet-based cognitive behavioural therapy (CBT) is as effective as synchronous CBT (sCBT) for treating Gambling Disorder (GD) in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Internet-based cognitive behavioral therapy and Synchronous cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Feb 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- To be included patients should:
- fulfil diagnostic criteria for GD (DSM-5).
- score 4 points or more on the National Opinion Research Centre Screen for Gambling Problems (NODS).
- be able to read, write, and speak Danish.
- have IT skills and access to the internet and a computer, smartphone, and/or tablet.
Who cannot join
- Patients are excluded from participation if they:
- present with severe comorbid somatic disease, cognitive deficits, severe trauma, and/or psychiatric disorder (e.g. depression, bipolar disorder, substance abuse, ADHD) that is insufficiently treated at the time of assessment and/or is evaluated to constitute a barrier for engaging in or benefitting from treatment.
- are not willing to engage in internet-delivered treatment or face-to-face cognitive behavioural therapy.
- do not provide informed consent.
- are in risk of suicide (indicated by clear intent and/or plans).
- have previously received treatment via or had access to the SpilleFri platform.
Show all 9Show fewer
- seek treatment as part of an imminent legal case.
- only fulfil diagnostic criteria for Gambling Disorder in relation to behaviour such as stock trading or buying and selling cryptocurrency.
- present with highly unstable social circumstances, which are considered to potentially pose a barrier to engaging in treatment (e.g., homelessness).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Denmark, 8000
Anna W Stenbro, Master's degree in Psychology,, +4541622166, anna.stenbro@rm.dk
Lisbeth Frostholm, Professor
About this study
Official title: Internet-based Versus Synchronous Cognitive Behavioural Therapy for Patients With Gambling Disorder: A Non-inferiority Randomized Controlled Trial
The aim of this two-armed, randomized controlled trial is to determine if internet-based cognitive behavioural therapy (CBT) is as effective as synchronous CBT (sCBT) for treating Gambling Disorder (GD) in adults. The main question it aims to answer is: Is the effect of the internet-based CBT ("SpilleFri") non-inferior to that of synchronous CBT in reducing gambling severity?
The trial will enroll 150 patients with Gambling Disorder who will be randomized (1:1) to either the experimental condition (12 weeks' treatment with the internet-based treatment "SpilleFri") or the active control condition (18 weeks individual sCBT). The primary outcome measure will be based on self-reported GD severity (NODS).
Read more
The trial will be considered effective if SpilleFri is not clinically inferior (within a predefined non-inferiority margin) to sCBT in reducing GD severity at the primary endpoint three months after end-of-treatment.
In addition to evaluating the effectiveness of the treatments, the study will conduct an exploratory analysis of the impact of each condition on secondary outcomes (changes in gambling behavior, relationship quality, and symptoms of anxiety, depression, and emotional distress). Similarly, an exploratory analysis of process variables (gambling-related self-efficacy, maladaptive gambling cognitions, emotion regulation difficulties, and gambling urge) will be conducted across conditions and clinical subgroups.
Participants will:
- Engage in nine structured modules of either internet-based CBT or sCBT
- Complete self-reported questionnaires on gambling severity and secondary symptoms at eight time points
- Have the option for up to three additional support sessions with a psychologist
Read the detailed description
PROJECT GROUP: Anna Westh Stenbro (Psychologist, MSc.); Lisbeth Frostholm (Professor, Psychologist, MSc., Ph.D.); David Hodgins (Professor, Psychologist, MSc., Ph.D.)
The trial will be conducted by the research group at the Research Clinic for Gambling Disorder, based at Aarhus University Hospital, Denmark. The clinic was established in 2007 and offers assessment and specialized treatment to patients with GD.
MEASUREMENTS:
Self-reported data from the participants are collected at seven time points: At baseline (T1), randomisation (T2), three time points mid-treatment (T3, T4, T5), end-of-treatment (T6) and at 3-month follow-up (T7, primary endpoint). Due to different treatment durations in the two arms, an additional measurement point (T7b) is added to control for the effect of time for participants in the SF group, at the time point when participants in the sCBT group complete the 3-month follow-up (week 30). At T6, all participants will be invited to participate in a 12-month follow-up study (T8).
During treatment, therapists register the length, and themes, of phone conversations and face-to-face sessions in SpilleFri and equally the length and overall themes of sessions in the sCBT arm. In both arms, therapists register involvement of concerned significant others in treatment sessions. In the sCBT arm, therapist register manual fidelity and covered intervention topics after each session. Deviations are described. At the end of the treatment course, the therapists evaluate participant engagement and treatment effect (CGI-I).
For a detailed list of the measures and measurement time points included, see the section "Outcome measures".
RANDOMIZATION:
Included patients will be randomized to SF or sCBT in a 1:1 ratio. Randomization takes place immediately following the inclusion conference. A member of the research group will perform the randomization using the randomization module in the online data collection program, REDCap. When the randomization module is activated, REDCap automatically and randomly assigns participants to one of the predefined study groups in randomization blocks randomly ranging between 8 and 12. All research group members and clinicians are blinded to the current randomization block size.
POWER CALCULATION:
Sample size estimation was done using simulation of mixed linear models in Stata version 17. The relative effects of SF and sCBT will be analysed using a pre-set non-inferiority margin, determining the margin within which SF can be less effective than sCBT without being declared clinically inferior to the standard treatment. Within this margin, any difference in effect will represent a clinically unimportant loss of effect.
Simulation parameters were informed by 1) previous clinical data from the RCGD on reduction in NODS for patients given sCBT and 2) reduction in NODS for patients in the SF feasibility study. Assuming baseline-EOT-FU trajectory in NODS-score of 7-1-1 in individual CBT condition and 7-2-2 in SF condition, power of .80 was reached for 100 patients (50 in each condition). To account for dropout and attrition, a sample size of 150 is ideal.
ANALYSIS:
The hypothesized non-inferiority of SF compared to individual CBT as measured by NODS will be analysed using 2-level mixed linear models with random intercept - i.e., repeated measures nested within patients. REML estimation will be employed. Model-predicted mean change in NODS from baseline to FU is estimated in both CBT and SF condition, and a 95% confidence interval for the difference in change, i.e., ΔCBT-ΔSF, is calculated. The null-hypothesis of inferiority is rejected if the upper bound of this confidence interval is greater than the inferiority bound defined to be -2 NODS-scale points, i.e., SF leads to a change in NODS not more than 2 points less than CBT. The inferiority bound was decided based on clinical experience from RCGD, judging how large a difference in NODS that is clinically visible.
Results will be analysed and reported according to the CONSORT statement. A statistician is continuously involved in the project.
- Conditions
- Gambling Disorder
- Being tested
- Internet-based cognitive behavioral therapy, Synchronous cognitive behavioral therapy
- Keywords
- Gambling Disorder treatment, Internet-based treatment, Cognitive behavioral therapy, Non-inferiority trial, Randomized controlled trial
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioral therapyBehavioural
Also called SpilleFri
The internet-based CBT treatment arm is delivered via the online treatment platform "SpilleFri" and consists of nine internet-delivered modules delivered over 10-12 weeks. Modules contain written assignments and multiple-choice lists, combined with psychoeducation delivered in text, illustrations, and videos. The treatment is assisted by a therapist. The therapist contact is primarily written and takes place in an embedded secured message system on the platform. Participants can use the written message function whenever they want, and the therapist will respond on a specific day each week. Further, participants are offered up to three sessions of face-to-face or video-based therapist support during the treatment, depending on their preference.
Treatment is regarded as completed if the participant has worked actively (logged in to the module and filled in at least one interactive exercise) in the first 6 modules of the treatment program.
Synchronous cognitive behavioral therapyBehavioural
Also called Face-to-face CBT
In the sCBT condition, participants receive 9 individual sessions spread over 14-20 weeks, in a 1 to 1 format with a therapist, delivered either face-to-face or via video connection, depending on the participant's preference (there may be a mix). Treatment sessions take place weekly at the start of the course. After week 4, the aim is to have sessions at least every other week to maintain continuity in treatment. Further, participants are offered up to three additional sessions that can be included on request of participant or when therapists deem it necessary. Treatment is regarded as completed if the participant has attended 6 sessions of the treatment program.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive behavioral therapy ("SpilleFri") | Experimental | Participants in this arm receive internet-based cognitive behavioral therapy via the therapist-guided online treatment platform "SpilleFri" Receives: Behavioral: Internet-based cognitive behavioral therapy |
| Synchronous cognitive behavioral therapy (sCBT) | Active comparator | Participants in this arm receive traditional synchronous cognitive behavioral therapy, face-to-face or via video-connection Receives: Behavioral: Synchronous cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gambling Problems Past Month as Assessed by The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
Measured by Danish translation of The National Opinion Research Center Screen for Gambling Problems (NODS). 17 items with a minimum score of 0 and a maximum score of 10, with higher scores meaning more servere gambling problems. Self-report measure collected through a web-based questionnaire program. For the purpose of the study, the NODS is modified to assess the last month instead of the last year.
Measured: Baseline, 12 weeks/18 weeks (post treatment SpilleFri/sCBT), 24 weeks/30 weeks (3 month FU SpilleFri/sCBT), 64 weeks/70 weeks (12 month FU SpilleFri/sCBT)
Secondary outcomes (7)
Change in Gambling Symptoms past week as Assessed by Gambling Symptom Assessment Scale (G-SAS)
The Gambling-Symptom Assessment Scale (G-SAS) is a 12-item self-rated measure that is designed to assess gambling symptom severity and change during treatment. Each item is scored on a 4-point scale from 0-4 with 0 meaning no symptoms and 4 meaning extreme symptoms. The total maximum score is 48.
Measured: Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Self-reported Gambling Net Loss past week as assessed by a single item
Estimated net loss past week. Single-item self-report measure collected through a web-based questionnaire program.
Measured: Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Overall health improvement
Measured by the 5-point clinical global improvement scale (CGI). The CGI is measured by self-report (CGI_p) and by clinician rating (CGI_c). 1 item assessing overall improvement or worsening on a 5-point scale with a maximum score of 5 and a minimum score of 1, with higher scores meaning a better outcome. Self-report measure collected throguh a web-based questionnaire program.
Measured: Post (week 12/18, clinician rating), 3 month FU (week 24/30, participant and clinician rating)
Change in Symptoms of anxiety, depression, and psychological distress as Assessed by th SCL-90
Measured by 13 relevant subscores of the 92-item Danish version of the Symptom Checklist (SCL-92). All items are rated on 5point scales. Maximum and minimum scores for the items are respectively 20 and 4 for anxiety, 30 and 6 for depression, and 40 and 8 for general distress, with higher scores meaning worse outcomes, i.e. more symptoms. Self-report collected through a web-based questionnaire program.
Measured: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Overall Quality of Life and General Health Satisfaction as Assessed by the WHOQoL
Overall quality of life and general health satisfaction is measured using two single-item subscales from the WHOQoL. Both items are scored on five-point Likert-scales with 1 indicating very poor quality of life/very low general health satisfaction, and 5 indicating best possible quality of life/health satisfaction.
Measured: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Quality of Current Romantic Relationship as Assessed by the DAS-4
For participants who indicate that they are in a committed romantic relationship at baseline, the Dyadic Adjustment Scale, Brief Version (DAS-4) is used to measure the quality of the current relationship.The DAS-4 consists of four items with a maximum score of 21, indicating a very high relationship quality, and a minimum score of 0.
Measured: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Participant treatment expectancy and satisfaction as Assessed by the Experienced Treatment Credibility and Expectancy
Measured by the credibility/expectancy questionnaire. 6 items rated on a 1-9 or a 0%-100% scale, depending upon the item. The scale yields a mean expectancy/satisfaction score, ranging from maximum 100 % to minimum 0 %, with higher scores meaning higher expectancy of/satisfaction with the treatment. Self- report collected through a web-based questionnaire program
Measured: Baseline and post (week 12/18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start24 Feb 2025
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Lisbeth Frostholm, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989125
- Sponsor's protocol ID
- 1-10-72-145-24
- Other IDs
- DLK-2308_002, 2023-4552
- Status last verified
- May 2025
- First submitted
- 21 Feb 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant anonymity, individual participant data (IPD) will not be shared. Instead, aggregate data will be shared in an anonymized form.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Versus Synchronous Cognitive Behavioural Therapy for Patients With Gambling Disorder: A Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06989125
- Acronym / sponsor ID
- 1-10-72-145-24
- Conditions
- Gambling Disorder
- Keywords
- Gambling Disorder treatment, Internet-based treatment, Cognitive behavioral therapy, Non-inferiority trial, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 May 2025 (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.
The aim of this two-armed, randomized controlled trial is to determine if internet-based cognitive behavioural therapy (CBT) is as effective as synchronous CBT (sCBT) for treating Gambling Disorder (GD) in adults. The main question it aims to answer is: Is the effect of the internet-based CBT ("SpilleFri") non-inferior to that of synchronous CBT in reducing gambling severity?
The trial will enroll 150 patients with Gambling Disorder who will be randomized (1:1) to either the experimental condition (12 weeks' treatment with the internet-based treatment "SpilleFri") or the active control condition (18 weeks individual sCBT). The primary outcome measure will be based on self-reported GD severity (NODS).
The trial will be considered effective if SpilleFri is not clinically inferior (within a predefined non-inferiority margin) to sCBT in reducing GD severity at the primary endpoint three months after end-of-treatment.
In addition to evaluating the effectiveness of the treatments, the study will conduct an exploratory analysis of the impact of each condition on secondary outcomes (changes in gambling behavior, relationship quality, and symptoms of anxiety, depression, and emotional distress). Similarly, an exploratory analysis of process variables (gambling-related self-efficacy, maladaptive gambling cognitions, emotion regulation difficulties, and gambling urge) will be conducted across conditions and clinical subgroups.
Participants will:
- Engage in nine structured modules of either internet-based CBT or sCBT
- Complete self-reported questionnaires on gambling severity and secondary symptoms at eight time points
- Have the option for up to three additional support sessions with a psychologist
Detailed description
PROJECT GROUP: Anna Westh Stenbro (Psychologist, MSc.); Lisbeth Frostholm (Professor, Psychologist, MSc., Ph.D.); David Hodgins (Professor, Psychologist, MSc., Ph.D.)
The trial will be conducted by the research group at the Research Clinic for Gambling Disorder, based at Aarhus University Hospital, Denmark. The clinic was established in 2007 and offers assessment and specialized treatment to patients with GD.
MEASUREMENTS:
Self-reported data from the participants are collected at seven time points: At baseline (T1), randomisation (T2), three time points mid-treatment (T3, T4, T5), end-of-treatment (T6) and at 3-month follow-up (T7, primary endpoint). Due to different treatment durations in the two arms, an additional measurement point (T7b) is added to control for the effect of time for participants in the SF group, at the time point when participants in the sCBT group complete the 3-month follow-up (week 30). At T6, all participants will be invited to participate in a 12-month follow-up study (T8).
During treatment, therapists register the length, and themes, of phone conversations and face-to-face sessions in SpilleFri and equally the length and overall themes of sessions in the sCBT arm. In both arms, therapists register involvement of concerned significant others in treatment sessions. In the sCBT arm, therapist register manual fidelity and covered intervention topics after each session. Deviations are described. At the end of the treatment course, the therapists evaluate participant engagement and treatment effect (CGI-I).
For a detailed list of the measures and measurement time points included, see the section "Outcome measures".
RANDOMIZATION:
Included patients will be randomized to SF or sCBT in a 1:1 ratio. Randomization takes place immediately following the inclusion conference. A member of the research group will perform the randomization using the randomization module in the online data collection program, REDCap. When the randomization module is activated, REDCap automatically and randomly assigns participants to one of the predefined study groups in randomization blocks randomly ranging between 8 and 12. All research group members and clinicians are blinded to the current randomization block size.
POWER CALCULATION:
Sample size estimation was done using simulation of mixed linear models in Stata version 17. The relative effects of SF and sCBT will be analysed using a pre-set non-inferiority margin, determining the margin within which SF can be less effective than sCBT without being declared clinically inferior to the standard treatment. Within this margin, any difference in effect will represent a clinically unimportant loss of effect.
Simulation parameters were informed by 1) previous clinical data from the RCGD on reduction in NODS for patients given sCBT and 2) reduction in NODS for patients in the SF feasibility study. Assuming baseline-EOT-FU trajectory in NODS-score of 7-1-1 in individual CBT condition and 7-2-2 in SF condition, power of .80 was reached for 100 patients (50 in each condition). To account for dropout and attrition, a sample size of 150 is ideal.
ANALYSIS:
The hypothesized non-inferiority of SF compared to individual CBT as measured by NODS will be analysed using 2-level mixed linear models with random intercept - i.e., repeated measures nested within patients. REML estimation will be employed. Model-predicted mean change in NODS from baseline to FU is estimated in both CBT and SF condition, and a 95% confidence interval for the difference in change, i.e., ΔCBT-ΔSF, is calculated. The null-hypothesis of inferiority is rejected if the upper bound of this confidence interval is greater than the inferiority bound defined to be -2 NODS-scale points, i.e., SF leads to a change in NODS not more than 2 points less than CBT. The inferiority bound was decided based on clinical experience from RCGD, judging how large a difference in NODS that is clinically visible.
Results will be analysed and reported according to the CONSORT statement. A statistician is continuously involved in the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavioral therapy ("SpilleFri") | Experimental | Behavioral: Internet-based cognitive behavioral therapyParticipants in this arm receive internet-based cognitive behavioral therapy via the therapist-guided online treatment platform "SpilleFri" |
| Synchronous cognitive behavioral therapy (sCBT) | Active comparator | Behavioral: Synchronous cognitive behavioral therapyParticipants in this arm receive traditional synchronous cognitive behavioral therapy, face-to-face or via video-connection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- fulfil diagnostic criteria for GD (DSM-5).
- score 4 points or more on the National Opinion Research Centre Screen for Gambling Problems (NODS).
- be able to read, write, and speak Danish.
- have IT skills and access to the internet and a computer, smartphone, and/or tablet.
Key exclusion criteria (9 listed)
- present with severe comorbid somatic disease, cognitive deficits, severe trauma, and/or psychiatric disorder (e.g. depression, bipolar disorder, substance abuse, ADHD) that is insufficiently treated at the time of assessment and/or is evaluated to constitute a barrier for engaging in or benefitting from treatment.
- are not willing to engage in internet-delivered treatment or face-to-face cognitive behavioural therapy.
- do not provide informed consent.
- are in risk of suicide (indicated by clear intent and/or plans).
- have previously received treatment via or had access to the SpilleFri platform.
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 |
|---|---|---|
| Internet-based cognitive behavioral therapyAlso: SpilleFriThe internet-based CBT treatment arm is delivered via the online treatment platform "SpilleFri" and consists of nine internet-delivered modules delivered over 10-12 weeks. Modules contain written assignments and multiple-choice lists, combined with psychoeducation delivered in text, illustrations, and videos. The treatment is assisted by a therapist. The therapist contact is primarily written and takes place in an embedded secured message system on the platform. Participants can use the written message function whenever they want, and the therapist will respond on a specific day each week. Further, participants are offered up to three sessions of face-to-face or video-based therapist support during the treatment, depending on their preference. Treatment is regarded as completed if the participant has worked actively (logged in to the module and filled in at least one interactive exercise) in the first 6 modules of the treatment program. | Behavioural | Internet-based cognitive behavioral therapy ("SpilleFri") |
| Synchronous cognitive behavioral therapyAlso: Face-to-face CBTIn the sCBT condition, participants receive 9 individual sessions spread over 14-20 weeks, in a 1 to 1 format with a therapist, delivered either face-to-face or via video connection, depending on the participant's preference (there may be a mix). Treatment sessions take place weekly at the start of the course. After week 4, the aim is to have sessions at least every other week to maintain continuity in treatment. Further, participants are offered up to three additional sessions that can be included on request of participant or when therapists deem it necessary. Treatment is regarded as completed if the participant has attended 6 sessions of the treatment program. | Behavioural | Synchronous cognitive behavioral therapy (sCBT) |
Primary outcome
Change in Gambling Problems Past Month as Assessed by The National Opinion Research Center DSM Screen for Gambling Problems (NODS)
Time frame: Baseline, 12 weeks/18 weeks (post treatment SpilleFri/sCBT), 24 weeks/30 weeks (3 month FU SpilleFri/sCBT), 64 weeks/70 weeks (12 month FU SpilleFri/sCBT)
Measured by Danish translation of The National Opinion Research Center Screen for Gambling Problems (NODS). 17 items with a minimum score of 0 and a maximum score of 10, with higher scores meaning more servere gambling problems. Self-report measure collected through a web-based questionnaire program. For the purpose of the study, the NODS is modified to assess the last month instead of the last year.
7 secondary outcomes
Change in Gambling Symptoms past week as Assessed by Gambling Symptom Assessment Scale (G-SAS)
Time frame: Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Self-reported Gambling Net Loss past week as assessed by a single item
Time frame: Baseline, during treatment (weeks 4, 7, 10), post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Overall health improvement
Time frame: Post (week 12/18, clinician rating), 3 month FU (week 24/30, participant and clinician rating)
Change in Symptoms of anxiety, depression, and psychological distress as Assessed by th SCL-90
Time frame: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Overall Quality of Life and General Health Satisfaction as Assessed by the WHOQoL
Time frame: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Change in Quality of Current Romantic Relationship as Assessed by the DAS-4
Time frame: Baseline, post (week 12/18), 3 month FU (week 24/30), 12 month FU (week 64/70)
Participant treatment expectancy and satisfaction as Assessed by the Experienced Treatment Credibility and Expectancy
Time frame: Baseline and post (week 12/18)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No. To protect participant anonymity, individual participant data (IPD) will not be shared. Instead, aggregate data will be shared in an anonymized form.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavioral therapy and Synchronous cognitive behavioral therapy in people with Gambling Disorder, run by Aarhus University Hospital at 1 site in Denmark.
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 9 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: looking for participants now, as of the sponsor's last update on 25 May 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna W Stenbro, Master's degree in Psychology (+4541622166, anna.stenbro@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gambling Problems Past Month as Assessed by The National Opinion Research Center DSM Screen for Gambling Problems (NODS) (time frame: Baseline, 12 weeks/18 weeks (post treatment SpilleFri/sCBT), 24 weeks/30 weeks (3 month FU SpilleFri/sCBT), 64 weeks/70 weeks (12 month FU SpilleFri/sCBT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.