Pathological GamblingNCT05051085
Feasibility of the Internet-delivered Treatment "SpilleFri" for Patients With Pathological Gambling
A study testing Internet-delivered treatment: "SpilleFri". in people with Pathological Gambling, run by Anna Westh Stenbro at 1 site in Denmark.
Trial summary
This uncontrolled feasibility pilot study explores the feasibility of a 10 week, 8-module, therapist-assisted, internet-delivered treatment program, "SpilleFri", for patients with Pathological Gambling. The study includes 25-30 participants aged 18-60 fulfilling diagnostic criteria for Pathological Gambling (ICD-10). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Internet-delivered treatment: "SpilleFri".
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 1 Apr 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet the diagnostic criteria for Pathological Gambling (ICD-10)
- Able to read, wright, and speak Danish to a degree that enables interaction with the Danish internet treatment program, SpilleFri
- IT skills and access to internet and computer/tablet
- Willingness to participate in an internet-delivered psychological treatment program for Pathological Gambling
Who cannot join
- Current moderate or severe psychiatric disorder that demands special, individualized treatment, or clinical suspicion hereof, e.g. treatment-demanding depression, personality disorder, psychotic symptoms
- Untreated ADHD, ADD, or cognitive deficits that will most likely inhibit the patient from being able to read, understand, and work relatively independently in the SpilleFri internet program.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Clinic on Gambling Disorder (Forskningsklinikken for Ludomani), Funktionelle Lidelser, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: "SpilleFri" - an Internet-delivered Treatment for Patients With Pathological Gambling. A Feasibility Pilot Study
This uncontrolled feasibility pilot study explores the feasibility of a 10 week, 8-module, therapist-assisted, internet-delivered treatment program, "SpilleFri", for patients with Pathological Gambling. The study includes 25-30 participants aged 18-60 fulfilling diagnostic criteria for Pathological Gambling (ICD-10). The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is 60 % of participants included in the study completing the treatment program.
Read the detailed description
"SpilleFri" - an Internet-delivered Treatment for Patients with Pathological Gambling. A Feasibility Pilot Study
Lisbeth Frostholm \& Anna Stenbro
Objective
The objective of this uncontrolled pilot study is to test the feasibility of a future RCT by exploring the feasibility of an internet-delivered treatment program, "SpilleFri", for patients with Pathological Gambling. The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is an a priori defined change in patient-rated gambling problems from before to after treatment.
Design
This study is designed as an uncontrolled, single-arm, single-center feasibility pilot study.
Participants
The study includes 25-30 participants included from September 2021 to March 2022. The participants are recruited from The Research Clinic on Gambling Disorder, Aarhus University Hospital, Denmark. Patients with Pathological Gambling are screened for eligibility by the eligibility criteria below. They undergo thorough diagnostic assessment by an authorized psychologist including diagnostic interview (Schedules for Clinical Assessment in Neuropsychiatry).
Intervention
"SpilleFri" is a newly developed internet-delivered therapist-assisted treatment program for patients with Pathological Gambling. The 8 modules contain text, video files with psychoeducation, guided exercises, and videos with former patients. During a period of 10 weeks, patients are guided through the program modules assisted by a trained psychologist.
Course
If eligible and willing to participate, patients are included in the pilot study and assigned to a therapist (a trained psychologist from The Research Clinic on Gambling Disorder). Patients are contacted by telephone by the therapist and guided to login to the program platform and initiate treatment. The therapist follows the patient through the 8 treatment modules and provides guidance when needed. Patients and therapists primarily communicate through asynchronously written messages. If deemed necessary by the therapist, up to four consultations (telephone-/video-based or with physical attendance at the clinic) may be offered to enhance patient motivation and/or treatment adherence and effect. Treatment duration is 10 weeks.
Measurements
Patient-rated outcome measures are collected through a web-based program at the time of screening (before inclusion) (T1), before treatment (T2), and at end of treatment (T3). Between 6 and 12 patients will be interviewed during and post treatment to assess patient experience and satisfaction with the treatment program.
Clinician ratings are collected at the time of diagnostic assessment and at end of treatment.
Measurements also include logged data from the "SpilleFri"-treatment internet program, e.g. regarding patient activity in the program and number of messages to/from therapist pr. patient.
Feasibility outcomes
- Recruitment and retention rates, time requirements and data completeness as measured by the rate of eligible patients willing to participate, the rate of included patients completing the treatment program (defined as completion of at least 5 modules), therapists' time spent per patient, and the rate of treatment completers providing full data
- Patients' impression of treatment effect as measured by the clinical global improvement scale (CGI_p)
- Patients' treatment satisfaction and assessment of program utility as measured by the credibility/expectancy questionnaire and a purpose designed patient satisfaction questionnaire
- Therapists' impression of treatment effect as measured by the clinical global improvement scale (CGI_c).
- Changes in patient-rated gambling problems from before to after the treatment measured by the NODS
Feasibility criteria
The investigators regard a future study testing the treatment program "SpilleFri" in an RCT as feasible if:
- 60 % of the patients included in the study complete the treatment program (defined as completion of at least 5 of 8 modules)
- 70 % of treatment completers provide data for primary gambling outcome variable (NODS)
- Conditions
- Pathological Gambling
- Being tested
- Internet-delivered treatment: "SpilleFri".
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered treatment: "SpilleFri".Behavioural
The guided internet program consists of 8 modules over a period of 10 weeks. The content is written psychoeducation, videos with patients and experts, and exercises (encouraging reflection, cognitive restructuring, and exposure). The program is therapist-guided; hence all patients will receive support primarily from a specific therapist during the 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered treatment: "SpilleFri". | Experimental | All participants receive the internet-delivered therapist-assisted 8-modules treatment program "SpilleFri". Receives: Behavioral: Internet-delivered treatment: "SpilleFri". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment and retention rate
Data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully delivered.
Primary feasibility outcome is recruitment and retention rate, collected through clinic records and therapist report in web-based questionnaire.
Measured: Weekly during the intervention, up to 14 weeks
Secondary outcomes (12)
Feasibility: Contact with therapist pr. patient
Collected through therapist report in web-based questionnaire and logged data from the treatment program "SpilleFri".
Measured: Weekly during the intervention, up to 14 weeks
Feasibility: Patient activity in treatment program (log-in time and duration, yielding total minutes spend in treatment program)
Collected through logged data from the treatment program "SpilleFri"
Measured: Weekly during the intervention, up to 14 weeks
Treatment expectancy and satisfaction
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 score, ranging from maximum 100 % to minimum 0 %. Self-report collected through a web-based questionnaire program
Measured: Immediately after inclusion in treatment. Before first treatment session
Treatment expectancy and satisfaction
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 satisfaction score, ranging from maximum 100 % to minimum 0 %. Self-report collected through a web-based questionnaire program
Measured: Immediately after the intervention
Clinician experience of treatment
Qualitative and quantivative description of individual treatment courses including items measuring patient work effort, motivational barriers, amount of therapist quidance needed, and therapists' overall experience and satisfaction with working with the treatment program. Collected through questionnaire in web-based program.
Measured: Immediately after the intervention
Gambling problems past month, change
Measured by Danish translation of The National Opinion Research Center Screen for Gambling Problems (NODS). 17 items with a maximum score of 10 (indicating a high level of gambling problems) and a minimum score of 0. 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.
New versions of two NODS items are added, due to extensive clinical experience with two original NODS items being consistently misunderstood by patients (item 3 and 8).
Measured: Baseline and immediately after the intervention
Gambling behavior past week, change
Purpose-made questionnaire with 6 items assessing present sense of control over gambling, gambling craving, motivation to stop gambling, and gambling behavior past week (including frequency, time spent, money spent, money won/lost). Self-report measure collected through a web-based questionnaire program. Each item is interpreted individually, yielding an indication of e.g. motivation to stop gambling ranging from 0 (low) to 2 (very high). Gambling frequency, money spent, and time spent is measured in respectively times pr. week, hours pr. week, Danish kroner pr. week)
Measured: Baseline (pre inclusion in treatment), post inclusion (before first session) and immediately after the intervention
Psychological well-being, change
Measured on the Five Well-Being Index (WHO-5), a 5 item scale with a maximum score of 100 (indicating best imaginable well-being) and a minimum score of 0. Self-report collected through a web-based questionnaire program.
Measured: Baseline and immediately after the intervention
Stress, change
Measured on two items from a stress assessment questionnaire developed by the Danish Health Authority ("Stress blandt unge", 2017). Self-report collected through a web-based questionnaire program.
Measured: Baseline and immediately after the intervention
Symptoms of anxiety, depression, and psychological distress, change
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. Self-report collected through a web-based questionnaire program.
Measured: Baseline and immediately after the intervention
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. Self-report measure collected throguh a web-based questionnaire program.
Measured: Immediately after the intervention
Patient quality of life, change
Measured on a 1 item, 11 point scale, where 10 indicates "the best possible life" and 0 indicates "the worst possible life". The scale is adapted from the Danish questionnaire "Ungdomsprofilen" from University of Southern Denmark. Self-report collected through a web-based questionnaire program.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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 Pathological GamblingStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Westh Stenbro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Westh Stenbro, Aarhus University Hospital
- Investigators
- Anna W Stenbro, MSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051085
- Sponsor's protocol ID
- 1-10-72-1-21
- Status last verified
- Jul 2022
- First submitted
- 27 Aug 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Publications
Stenbro AW, Moldt S, Eriksen JW, Frostholm L. "I was Treated by the Program, the Therapist, and Myself": Feasibility of an Internet-Based Treatment Program for Gambling Disorder. J Gambl Stud. 2023 Dec;39(4):1885-1907. doi: 10.1007/s10899-023-10199-x. Epub 2023 Mar 31.
PubMed 37000310
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "SpilleFri" - an Internet-delivered Treatment for Patients With Pathological Gambling. A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT05051085
- Acronym / sponsor ID
- 1-10-72-1-21
- Conditions
- Pathological Gambling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Anna Westh StenbroUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 21 Sep 2021 (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.
This uncontrolled feasibility pilot study explores the feasibility of a 10 week, 8-module, therapist-assisted, internet-delivered treatment program, "SpilleFri", for patients with Pathological Gambling. The study includes 25-30 participants aged 18-60 fulfilling diagnostic criteria for Pathological Gambling (ICD-10). The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is 60 % of participants included in the study completing the treatment program.
Detailed description
"SpilleFri" - an Internet-delivered Treatment for Patients with Pathological Gambling. A Feasibility Pilot Study
Lisbeth Frostholm \& Anna Stenbro
Objective
The objective of this uncontrolled pilot study is to test the feasibility of a future RCT by exploring the feasibility of an internet-delivered treatment program, "SpilleFri", for patients with Pathological Gambling. The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is an a priori defined change in patient-rated gambling problems from before to after treatment.
Design
This study is designed as an uncontrolled, single-arm, single-center feasibility pilot study.
Participants
The study includes 25-30 participants included from September 2021 to March 2022. The participants are recruited from The Research Clinic on Gambling Disorder, Aarhus University Hospital, Denmark. Patients with Pathological Gambling are screened for eligibility by the eligibility criteria below. They undergo thorough diagnostic assessment by an authorized psychologist including diagnostic interview (Schedules for Clinical Assessment in Neuropsychiatry).
Intervention
"SpilleFri" is a newly developed internet-delivered therapist-assisted treatment program for patients with Pathological Gambling. The 8 modules contain text, video files with psychoeducation, guided exercises, and videos with former patients. During a period of 10 weeks, patients are guided through the program modules assisted by a trained psychologist.
Course
If eligible and willing to participate, patients are included in the pilot study and assigned to a therapist (a trained psychologist from The Research Clinic on Gambling Disorder). Patients are contacted by telephone by the therapist and guided to login to the program platform and initiate treatment. The therapist follows the patient through the 8 treatment modules and provides guidance when needed. Patients and therapists primarily communicate through asynchronously written messages. If deemed necessary by the therapist, up to four consultations (telephone-/video-based or with physical attendance at the clinic) may be offered to enhance patient motivation and/or treatment adherence and effect. Treatment duration is 10 weeks.
Measurements
Patient-rated outcome measures are collected through a web-based program at the time of screening (before inclusion) (T1), before treatment (T2), and at end of treatment (T3). Between 6 and 12 patients will be interviewed during and post treatment to assess patient experience and satisfaction with the treatment program.
Clinician ratings are collected at the time of diagnostic assessment and at end of treatment.
Measurements also include logged data from the "SpilleFri"-treatment internet program, e.g. regarding patient activity in the program and number of messages to/from therapist pr. patient.
Feasibility outcomes
- Recruitment and retention rates, time requirements and data completeness as measured by the rate of eligible patients willing to participate, the rate of included patients completing the treatment program (defined as completion of at least 5 modules), therapists' time spent per patient, and the rate of treatment completers providing full data
- Patients' impression of treatment effect as measured by the clinical global improvement scale (CGI_p)
- Patients' treatment satisfaction and assessment of program utility as measured by the credibility/expectancy questionnaire and a purpose designed patient satisfaction questionnaire
- Therapists' impression of treatment effect as measured by the clinical global improvement scale (CGI_c).
- Changes in patient-rated gambling problems from before to after the treatment measured by the NODS
Feasibility criteria
The investigators regard a future study testing the treatment program "SpilleFri" in an RCT as feasible if:
- 60 % of the patients included in the study complete the treatment program (defined as completion of at least 5 of 8 modules)
- 70 % of treatment completers provide data for primary gambling outcome variable (NODS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered treatment: "SpilleFri". | Experimental | Behavioral: Internet-delivered treatment: "SpilleFri".All participants receive the internet-delivered therapist-assisted 8-modules treatment program "SpilleFri". |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for Pathological Gambling (ICD-10)
- Able to read, wright, and speak Danish to a degree that enables interaction with the Danish internet treatment program, SpilleFri
- IT skills and access to internet and computer/tablet
- Willingness to participate in an internet-delivered psychological treatment program for Pathological Gambling
Key exclusion criteria (2 listed)
- Current moderate or severe psychiatric disorder that demands special, individualized treatment, or clinical suspicion hereof, e.g. treatment-demanding depression, personality disorder, psychotic symptoms
- Untreated ADHD, ADD, or cognitive deficits that will most likely inhibit the patient from being able to read, understand, and work relatively independently in the SpilleFri internet program.
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-delivered treatment: "SpilleFri".The guided internet program consists of 8 modules over a period of 10 weeks. The content is written psychoeducation, videos with patients and experts, and exercises (encouraging reflection, cognitive restructuring, and exposure). The program is therapist-guided; hence all patients will receive support primarily from a specific therapist during the 10 weeks. | Behavioural | Internet-delivered treatment: "SpilleFri". |
Primary outcome
Feasibility: Recruitment and retention rate
Time frame: Weekly during the intervention, up to 14 weeks
Data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully delivered. Primary feasibility outcome is recruitment and retention rate, collected through clinic records and therapist report in web-based questionnaire.
12 secondary outcomes
Feasibility: Contact with therapist pr. patient
Time frame: Weekly during the intervention, up to 14 weeks
Feasibility: Patient activity in treatment program (log-in time and duration, yielding total minutes spend in treatment program)
Time frame: Weekly during the intervention, up to 14 weeks
Treatment expectancy and satisfaction
Time frame: Immediately after inclusion in treatment. Before first treatment session
Treatment expectancy and satisfaction
Time frame: Immediately after the intervention
Clinician experience of treatment
Time frame: Immediately after the intervention
Gambling problems past month, change
Time frame: Baseline and immediately after the intervention
Gambling behavior past week, change
Time frame: Baseline (pre inclusion in treatment), post inclusion (before first session) and immediately after the intervention
Psychological well-being, change
Time frame: Baseline and immediately after the intervention
Stress, change
Time frame: Baseline and immediately after the intervention
Symptoms of anxiety, depression, and psychological distress, change
Time frame: Baseline and immediately after the intervention
Overall health improvement
Time frame: Immediately after the intervention
Patient quality of life, change
Time frame: Baseline and immediately after the intervention
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 20 Jul 2022.
- Derived from this study: PubMed 37000310Stenbro AW, Moldt S, Eriksen JW, Frostholm L. "I was Treated by the Program, the Therapist, and Myself": Feasibility of an Internet-Based Treatment Program for Gambling Disorder. J Gambl Stud. 2023 Dec;39(4):1885-1907. doi: 10.1007/s10899-023-10199-x. Epub 2023 Mar 31.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
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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.
Anna W Stenbro, MSc principal investigator
Aarhus University Hospital
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-delivered treatment: "SpilleFri". in people with Pathological Gambling, run by Anna Westh Stenbro 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 4 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 20 Jul 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 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?
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?
Feasibility: Recruitment and retention rate (time frame: Weekly during the intervention, up to 14 weeks). 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 NCT05051085, 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 20 Jul 2022.