Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility of the Internet-delivered Treatment "SpilleFri" for Patients With Pathological Gambling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05051085
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Anna Westh Stenbro, Aarhus University Hospital

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Pathological Gambling Behavioral: Internet-delivered treatment: "SpilleFri". Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "SpilleFri" - an Internet-delivered Treatment for Patients With Pathological Gambling. A Feasibility Pilot Study
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : March 20, 2022
Estimated Study Completion Date : March 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Internet-delivered treatment: "SpilleFri".
All participants receive the internet-delivered therapist-assisted 8-modules treatment program "SpilleFri".
Behavioral: 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Feasibility: Contact with therapist pr. patient [ Time Frame: Weekly during the intervention, up to 14 weeks ]
    Collected through therapist report in web-based questionnaire and logged data from the treatment program "SpilleFri".

  2. 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 ]
    Collected through logged data from the treatment program "SpilleFri"

  3. Treatment expectancy and satisfaction [ Time Frame: Immediately after inclusion in treatment. Before first treatment session ]
    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

  4. Treatment expectancy and satisfaction [ Time Frame: Immediately after the intervention ]
    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

  5. Clinician experience of treatment [ Time Frame: Immediately after the intervention ]
    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.

  6. Gambling problems past month, change [ Time Frame: Baseline and immediately after the intervention ]

    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).


  7. Gambling behavior past week, change [ Time Frame: Baseline (pre inclusion in treatment), post inclusion (before first session) and immediately after the intervention ]
    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)

  8. Psychological well-being, change [ Time Frame: Baseline and immediately after the intervention ]
    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.

  9. Stress, change [ Time Frame: Baseline and immediately after the intervention ]
    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.

  10. Symptoms of anxiety, depression, and psychological distress, change [ Time Frame: Baseline and immediately after the intervention ]
    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.

  11. Overall health improvement [ Time Frame: Immediately after the intervention ]
    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.

  12. Patient quality of life, change [ Time Frame: Baseline and immediately after the intervention ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05051085


Contacts
Layout table for location contacts
Contact: Anna W Stenbro, MSc +4541622166 anna.stenbro@rm.dk
Contact: Lisbeth Frostholm, PhD +4522618875 lisbeth.frostholm@aarhus.rm.dk

Locations
Layout table for location information
Denmark
Research Clinic on Gambling Disorder (Forskningsklinikken for Ludomani), Funktionelle Lidelser, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Anna W Stenbro, MSc    +4541622166    anna.stenbro@rm.dk   
Sponsors and Collaborators
Anna Westh Stenbro
Investigators
Layout table for investigator information
Principal Investigator: Anna W Stenbro, MSc Aarhus Universitetshospital
Layout table for additonal information
Responsible Party: Anna Westh Stenbro, Researcher, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT05051085    
Other Study ID Numbers: 1-10-72-1-21
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made available to other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders