Clinical trial NCT05051085: Feasibility of the Internet-delivered Treatment "SpilleFri" for Patients With Pathological Gambling
Official title: "SpilleFri" - an Internet-delivered Treatment for Patients With Pathological Gambling. A Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathological Gambling
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.

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)

Eligibility 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.

Primary outcomes:
measure: Feasibility: Recruitment and retention rate
timeFrame: Weekly during the intervention, up to 14 weeks
Secondary outcomes:
measure: Feasibility: Contact with therapist pr. patient
timeFrame: Weekly during the intervention, up to 14 weeks
measure: Feasibility: Patient activity in treatment program (log-in time and duration, yielding total minutes spend in treatment program)
timeFrame: Weekly during the intervention, up to 14 weeks
measure: Treatment expectancy and satisfaction
timeFrame: Immediately after inclusion in treatment. Before first treatment session
measure: Treatment expectancy and satisfaction
timeFrame: Immediately after the intervention
measure: Clinician experience of treatment
timeFrame: Immediately after the intervention
measure: Gambling problems past month, change
timeFrame: Baseline and immediately after the intervention
measure: Gambling behavior past week, change
timeFrame: Baseline (pre inclusion in treatment), post inclusion (before first session) and immediately after the intervention
measure: Psychological well-being, change
timeFrame: Baseline and immediately after the intervention
measure: Stress, change
timeFrame: Baseline and immediately after the intervention
measure: Symptoms of anxiety, depression, and psychological distress, change
timeFrame: Baseline and immediately after the intervention
measure: Overall health improvement
timeFrame: Immediately after the intervention
measure: Patient quality of life, change
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Research Clinic on Gambling Disorder (Forskningsklinikken for Ludomani), Funktionelle Lidelser, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Anna W Stenbro, MSc
role: PRINCIPAL_INVESTIGATOR
References: