NCT03946098

Brief Summary

Problem gambling (PG) is a major public health concern worldwide. As awareness of PG has risen, treatment demand is increasing, and internet interventions is a promising alternative for providing fast, evidence-based treatment at scale, to a low cost. This article presents the protocol of an open label, uncontrolled pilot and feasibility trial of a novel internet-delivered cognitive behavioral treatment, conducted in regular addiction care with adult treatment-seeking patients (max N=25) with problematic gambling. Weekly measures of gambling symptoms and gambling will serve as outcome measures. Study results will further guide the development of the intervention and its implementation into regular addiction care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 4, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

1.4 years

First QC Date

April 28, 2019

Last Update Submit

December 11, 2021

Conditions

Problem GamblingGambling Disorder

Keywords

Internet interventionGambling DisorderCognitive-behavioral therapyPsychiatric comorbidityRegular addiction careProblem gambling

Outcome Measures

Primary Outcomes (1)

  • The Gambling Symptom Assessment Scale (G-SAS)

    Gambling symptoms

    Past 7 days

Secondary Outcomes (6)

  • The Gambling Time Line Follow Back (TLFB-G)

    Past 7 days

  • The 9-item Patient Health Questionnaire (PHQ-9

    Past 2 weeks

  • The 7-item Generalised Anxiety Disorder scale (GAD-7)

    Past 2 weeks

  • The Alcohol Use Disorders Identification Test (AUDIT)

    Past 12 months

  • The Drug Use Disorders Identification Test (DUDIT)

    Past 12 months

  • +1 more secondary outcomes

Study Arms (1)

iCBT for Gambling Disorder

EXPERIMENTAL

Treatment will consist of a 1+10 module internet delivered CBT program targeting problem gambling, newly developed. A bottom-up procedure was used to develop the treatment protocol, inspired by Clark's (2004) method for developing novel CBT treatments. We developed a clinical model delineating what factors contribute to the persistence of problem gambling behavior, and aligned these with targeted treatment interventions; based on behavioral upon research on the learning and maintenance processes of gambling behavior (Ramnerö et al, in press), theoretical models of gambling and comorbidity (Blaszczynski \& Nower, 2002); as well as qualitative interviews with treatment seeking gamblers with or without comorbidity.

Behavioral: iCBT

Interventions

iCBTBEHAVIORAL

A newly developed iCBT protocol targeting problem gambling.

iCBT for Gambling Disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being at least 18 years old
  • living in Sweden
  • being able to read and write Swedish.
  • having a total score of \>= 3 on the Problem Gambling Severity Index (PGSI; Ferris \& Wynne, 2001)
  • having the ability to work with online treatment material by themselves (with support from a therapist)

You may not qualify if:

  • fulfilling criteria for ongoing manic episode
  • currently undergoing a parallel CBT treatment for Gambling Disorder or problem gambling.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

eStöd

Stockholm, 117 61, Sweden

Location

Related Publications (1)

  • Molander O, Lindner P, Ramnero J, Bjureberg J, Carlbring P, Berman AH. Internet-based cognitive behavior therapy for problem gambling in routine care: protocol for a non-randomized pilot and feasibility trial. Pilot Feasibility Stud. 2020 Jul 21;6:106. doi: 10.1186/s40814-020-00647-5. eCollection 2020.

    PMID: 32699645DERIVED

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Philip H Lindner, PhD

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 28, 2019

First Posted

May 10, 2019

Study Start

October 4, 2019

Primary Completion

February 9, 2021

Study Completion

February 9, 2021

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)