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Pathological GamblingNCT05506384

Treatment Study for Problematic Gaming and Gambling

A study testing Relaps Preventions Therapy and Treatment as usual in people with Pathological Gambling and Internet Gaming Disorder, run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is twofold: 1) to evaluate an Relaps Prevention(RP) treatment for Problematic Gaming (PG) and Internet Gaming Disorder (IGD) patients recruited from child and youth psychiatry (CAP) clinics and 2) to test whether the quality of parent-child relationships plays role in the effect of RP treatment… Read more about this study

Who is it for?
Ages 12 to 18 years
What is being tested?
Relaps Preventions Therapy and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSweden
Study dates
1 May 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • age 12-18
  • over cut-off on GASA
  • over cut-off on CLiP

Who cannot join

  • not being able to speak Swedish

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Child and adolescent Clinic Rehion Skane

    Lund

Other trials in Sweden

About this study

The aim of the study is twofold: 1) to evaluate an Relaps Prevention(RP) treatment for Problematic Gaming (PG) and Internet Gaming Disorder (IGD) patients recruited from child and youth psychiatry (CAP) clinics and 2) to test whether the quality of parent-child relationships plays role in the effect of RP treatment and vice versa - whether the RP treatment has a spillover effect on the quality of parent-child relationships.

Read the detailed description

This study is a two-arm, parallel-group, single-blind, early-stage Randomized Clinical Trial (RCT) with embedded qualitative components. Participants will be randomized in a 1:1 ratio to either intervention or control, with a total of 162 participants (81+81) in the trial. The primary outcomes are measures of gaming and gambling behavior pre- and post-intervention, and the secondary outcomes include child ratings of parent-child communication, including parental knowledge, control and solicitousness about child gaming, as well as child disclosure and secrecy related to gaming.

Preliminary analyses will be conducted with regression analyses, paired sample t-tests and ANOVAs and performed in Mplus. In addition to the RCT, the study will be supplemented with a qualitative component with semi-structured individual interviews to capture participants' and clinicians' experiences of the treatment, as well as attitudes about parent-child relationships and parenting needs in carers whose children completed the RP treatment. The qualitative data will be analyzed with thematic analysis.

Being tested
Relaps Preventions Therapy, Treatment as usual
Keywords
Gaming, Gambling, Adolescent, Children
Medical subject headings
Gambling, Internet Addiction Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relaps Preventions TherapyBehavioural

    The treatment consists of three parts: 1) setting goals, 2) understanding and identifying high-risk situations and problem behaviors, and 3) consolidating the new activity schedule and identifying future high-risk behaviors. The first part is focused on examining the patient's undesirable behavior, his/her motivation for change, and establishing goals with the. The second part, drawing more from traditional Cognitive Behavioral Therapy (CBT) techniques, consists of exploring problematic situations, identifying high-risk situations and events, emotions and cognitions that induce the problematic gaming behavior or result in a relapse; managing game time with activity scheduling and practicing problem-solving skills. The final part consists of recognizing early warning signals that may indicate that the primary problem behavior is more likely to occur and consolidating the parts of the treatment that have been most helpful in maintaining the new activity schedule.

  • Treatment as usualBehavioural

    This group will receive treatment as usual at their Child and Adolescent Psychiatry Clinic.

Study groups in NCT05506384
Study groupRoleWhat they receive
Relaps prevention treatmentExperimentalThe treatment will be administered in an individual format and consist of seven to nine sessions of 45 minutes over a period of seven to nine weeks. The number of sessions can vary to be able to accommodate the fact that participants may have different levels of motivation for changing their primary problem behavior, which is why some participants may require one or two extra sessions at the start of the treatment. The treatment will be offered to participants both in person and via video link to facilitate participation for children and adolescents living further away from the participating clinics.
Receives: Behavioral: Relaps Preventions Therapy
Treatment as usualOtherThe patients in this arm will get treatment as usual at their Child and Adolescent psychiatry clinic.
Receives: Behavioral: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gaming changes

    Changes in gaming measured with Game Addiction Scale for Adolescents (GASA) . GASA applies to gaming behavior during the last 6 months with 7 items. Each question covers one criterion in the Diagnostic and Statistical Manual 5 (DSM-5), answered on a 5-point Likert scale ranging from 1 (never) to 5 (very often) and should according to the developer be counted as endorsed when rated 3 or higher.

    Min: 0 Max: 35 A higher outcome means worse gaming problems

    Measured: treatment and 3 months

  2. Gambling changes

    Changes in gambling measured with National Opinion Research Center (NORC) Diagnostic Screen for Gambling Disorders (NODS), three NODS questions, pertaining to loss of Control, Lying, and Preoccupation (CLiP).

    NODS-CLiP is the shorter form of NODS.

    Min: 0 Max:3 A higher outcome means worse gambling problems.

    Measured: treatment and 3 months

Secondary outcomes (1)

  1. Family climate/communication

    Changes in family climate/communication.

    Parent-child communication includes six subscales. Items are rated on a five-point Likert scale ranging from 1 (often) to 5 (Never).

    Min: 0 Max: 30 A higher outcome means worse communication.

    Family climate , includes two subscales, family cohesion and conflict. While family cohesion assesses the bonds between family members, family conflict assesses the conflicts between family members. A total of 11 questions.

    Items are rated on a four-point scale, ranging from 1 (not true at all) to 4 (very true).

    Min: 0 Max: 44 A higher outcome means worse family climate.

    Measured: treatment and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2022
  2. Study start1 May 2021
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05506384
Sponsor's protocol ID
2019-04797
Other IDs
2019
Status last verified
Feb 2024
First submitted
8 Aug 2022
Last updated
1 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andre F, Kapetanovic S, Einarsson I, Trebbin Harvard S, Franzen L, Mottus A, Hakansson A, Claesdotter-Knutsson E. Relapse prevention therapy for internet gaming disorder in Swedish child and adolescent psychiatric clinics: a randomized controlled trial. Front Psychiatry. 2023 Oct 20;14:1256413. doi: 10.3389/fpsyt.2023.1256413. eCollection 2023.

    PubMed 37928925

  • Kapetanovic S, Gurdal S, Einarsson I, Werner M, Andre F, Hakansson A, Claesdotter-Knutsson E. Relapse Prevention Therapy for Problem Gaming or Internet Gaming Disorder in Swedish Child and Youth Psychiatric Clinics: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 5;12:e44318. doi: 10.2196/44318.

    PubMed 36602846

Questions about this trial

What is this clinical trial studying?

A study testing Relaps Preventions Therapy and Treatment as usual in people with Pathological Gambling and Internet Gaming Disorder, run by Region Skane at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gaming changes (time frame: treatment and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05506384, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.

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