Feasibility of the Internet-delivered Treatment "SpilleFri" for Patients With Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional

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.
    

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

        1. 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

        2. Patients' impression of treatment effect as measured by the clinical global improvement
           scale (CGI_p)

        3. Patients' treatment satisfaction and assessment of program utility as measured by the
           credibility/expectancy questionnaire and a purpose designed patient satisfaction
           questionnaire

        4. Therapists' impression of treatment effect as measured by the clinical global
           improvement scale (CGI_c).

        5. 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:

        1. 60 % of the patients included in the study complete the treatment program (defined as
           completion of at least 5 of 8 modules)

        2. 70 % of treatment completers provide data for primary gambling outcome variable (NODS)
    

Intervention name(s): Internet-delivered treatment: "SpilleFri".
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment