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

NCT05051085 | Completed

• 1 other identifier: 1-10-72-1-21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pathological Gambling

Outcome Measures

Primary Outcomes (1)

• 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.

  Weekly during the intervention, up to 14 weeks

Secondary Outcomes (12)

• Feasibility: Contact with therapist pr. patient

  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)

  Weekly during the intervention, up to 14 weeks

• Treatment expectancy and satisfaction

  Immediately after inclusion in treatment. Before first treatment session

• Treatment expectancy and satisfaction

  Immediately after the intervention

• Clinician experience of treatment

  Immediately after the intervention

Study Arms (1)

Internet-delivered treatment: "SpilleFri".

EXPERIMENTAL

All participants receive the internet-delivered therapist-assisted 8-modules treatment program "SpilleFri".

Behavioral: Internet-delivered treatment: "SpilleFri".

Interventions

Internet-delivered treatment: "SpilleFri". BEHAVIORAL

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.

Internet-delivered treatment: "SpilleFri".

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Westh Stenbro: lead

Study Sites (1)

Research Clinic on Gambling Disorder (Forskningsklinikken for Ludomani), Funktionelle Lidelser, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37000310 DERIVED

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Study Officials

• Anna W Stenbro, MSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 21, 2021
• Study Start: September 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)