Condition category
Mental and Behavioural Disorders
Date applied
24/04/2019
Date assigned
25/04/2019
Last edited
25/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Gambling addiction is a common problem with serious consequences for those affected. It often leads to problems financially, in close relationships, and with mental health. At the same time it is rare that those affected seek treatment. It is therefore important to find effective treatments that are also acceptable to most people. The aim of this study is to test Cognitive Behavioural Therapy (CBT) given over the internet, in the treatment of gambling addiction.

Who can participate?
Adults between ages 18-75 treated at a centre for gambling addiction in Sweden

What does the study involve?
Participants are randomly allocated to CBT or a control treatment. Both treatments are given over the internet, with telephone support from a therapist and last for 8 weeks, but the content of the treatments differs. Gambling-related behaviour is measured at the start of the study, during treatment, at treatment end and at follow-ups at 6, 12 and 24 months after treatment.

What are the possible benefits and risks of participating?
The main benefit is that participants will receive a treatment over the internet (if they don't enter the study they will receive group therapy at the clinic) which makes it possible to partake in treatment over geographical distances and at times chosen by the participant. Possible risks are that the control treatment might be less effective, and therefore that participants allocated to the control group won't get the same treatment effect. If not satisfied with the treatment, participants will however be able to recieve regular treatment at the clinic after they finish the treatment in the study.

Where is the study run from?
Sahlgrenska University Hospital (unit for gambling addiction and screen health), Gothenburg, Sweden

When is the study starting and how long is it expected to run for?
May 2019 to December 2024

Who is funding the study?
1. Sahlgrenska University Hospital
2. Fredrik och Ingrid Thurings stiftelse

Who is the main contact?
Anna Söderpalm Gordh
anna.soderpalm@neuro.gu.se

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Anna Gordh

ORCID ID

Contact details

Mellangatan 1
Gothenburg
41301
Sweden
+46 (0)734020237
anna.soderpalm@neuro.gu.se

Type

Scientific

Additional contact

Mr Mikael Mide

ORCID ID

Contact details

Mellangatan 1
Gothenburg
41301
Sweden
+46 (0)700825194
mikael.mide@vgregion.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IKBT 631-18

Study information

Scientific title

Effectiveness of an internet-based cognitive behavioural treatment for disordered gamblers in a specialized outpatient setting: a randomised controlled trial

Acronym

Study hypothesis

This study aims to assess whether an 8-week CBT-based treatment delivered over the internet can be effective for pathological gamblers (n=180) in a clinical setting compared to a control treatment.

Main hypothesis: Participants receiving the internet CBT treatment will display significant reductions in behaviours associated with disordered gambling compared to participants in the control condition.

Secondary hypothesis 1: Participants with comorbid psychiatric symptoms will be compared with participants without after receiving the internet CBT treatment. The researchers hypothesize that both participants with and without co-morbid psychiatric symptoms (such as ADHD, depression) will benefit from the CBT treatment.

Secondary hypothesis 2: Participants receiving the internet CBT treatment will display significant reductions in irrational gambling related beliefs compared to participants in the control condition.

Ethics approval

Approved 26/11/2018, Ethical Review Agency (Etikprövningsmyndigheten, Box 2110, 750 02 Uppsala, Sweden; Tel: +46 (0)10 475 08 00; Email: registrator@etikprovning.se), ref: 631-18

Study design

Single-center single-blinded interventional randomized control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Gambling disorder

Intervention

Participants will be randomized to either the treatment being evaluated (ICBT) or an active control group (IMI).

A randomization sequence was made before enrollment of patients by a statistician not affiliated with the study. As participants will be enrolled continually over 3 years, a procedure has been developed where the randomized sequence has been put in envelopes. As each patient is enrolled they will be randomized to one of the study arms by opening the next envelope in the sequence. In this way randomization is kept apart from the research group.

The ICBT treatment consists of an 8-week internet-delivered treatment based on cognitive behavioural therapy. Patients will work through modules containing psychoeducation and cbt-exercises, one module/week. They will have active therapist support, by short e-mail messages and short telephone contacts once a week.

The IMI is an Motivational Interviewing (MI) based active control treatment designed specifically for this study. The control treatment is made to in form be similar to the evaluated treatment, but to not contain CBT elements. It is designed to provide psychoeducation, motivational enhancement and support. It also consists of 8 modules over 8 weeks. It will contain feedback via e-mail, and telephone support. However, the content of the modules is more limited. It mainly contains psychoeducation about gambling and gambling disorder and open-ended questions congruent with MI. MI will be used for the telephone support.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Gambling-related behaviour measured using the NODS: The NORC Diagnostic Screen for Gambling Problems (NODS) (Wickwire et al., 2008) and The Time Line Follow Back (TLFB), adapted to measure pathological gambling (G-TLFB) (Hodgins & Makarchuk 2003). NODS will be adapted to a 14-day version. It will be administered at assessment, baseline, every 14 days of treatment, at treatment end and at follow-ups at 6, 12 and 24 months post-treatment. The GTLFB will be administered at baseline, every 7 days during treatment, at treatment end and at follow-ups at 6, 12 and 24 months post-treatment.

Secondary outcome measures

1. Gambling-related cognitions assessed using The Gamblers Belief Questionnaire (GBQ) (Steenbergh, Meyers, May & Whelan, 2002) at baseline, after 28 days, at treatment end and at follow-ups at 6, 12 and 24 months post-treatment.
2. Depressive symptoms assessed using The Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer, & Williams, 2001) at baseline, every 7 days during treatment, at treatment end and at follow-ups at 6, 12 and 24 months post-treatment.
3. Anxiety symptoms assessed using The Generalized Anxiety Disorder 7-item scale (GAD-7) (Spitzer, Kroenke, Williams, & Löwe, 2006) at baseline, after 28 days, at treatment end and at follow-ups at 6, 12 and 24 months post-treatment.
4. Quality of life assessed using The Brunnsviken Brief Quality of Life Scale (BBQ) (Lindner et al., 2016) at baseline, at treatment end and at follow-ups at 6, 12 and 24 months post-treatment.

Overall trial start date

30/06/2018

Overall trial end date

31/12/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Eligible participants are all patients that are treated at the Unit for gambling addiction and screen health, Sahlgrenska University, Gothenburg, Sweden, and that meet the following inclusion criteria:
1. 18-75 years old
2. Any gender
3. Meet DSM-5 criteria for Gambling Disorder
4. Have access to the internet
5. Are able to read and write Swedish fluently

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

190

Participant exclusion criteria

Participants will be excluded if they:
1. Have somatic or psychiatric conditions that contraindicate treatment or severely hinders treatment participation (e.g. ongoing psychotic, manic or hypomanic episode, or a developmental disorder causing severe disability)
2. Have an increased risk of suicide (based on assessment during the diagnostic interview)
3. Are currently in another ongoing psychological treatment with similar content as the one offered in this study
4. Have started medication for a psychiatric condition during the last three weeks
5. Plan to start another treatment (psychotherapy or medication) for their gambling disorder during the course of the 8-week treatment

Recruitment start date

08/05/2019

Recruitment end date

31/12/2022

Locations

Countries of recruitment

Sweden

Trial participating centre

Sahlgrenska University Hospital (unit for gambling addiction and screen health)
Sahlgrenska Universitetssjukhuset
Gothenburg
41345
Sweden

Sponsor information

Organisation

Sahlgrenska University Hospital

Sponsor details

Addiction Clinic
Journalvägen 5
Sahlgrenska Universitetssjukhuset
Gothenburg
41345
Sweden
+46 (0)313421000
sahlgrenska.universitetssjukhuset@vgregion.se

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Sahlgrenska University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fredrik och Ingrid Thurings Stiftelse

Alternative name(s)

Fredrik and Ingrid Thurings Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available . The anonymized encrypted data will be stored on local servers as per the standard procedures of Sahlgrenska University Hospital.

Intention to publish date

31/05/2023

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/04/2019: Trial's existence confirmed by the ethics board.