A randomized controlled trial of an Internet-based psychological treatment for disordered gambling
| ISRCTN | ISRCTN38692394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38692394 |
| Secondary identifying numbers | IKBT 631-18 |
- Submission date
- 24/04/2019
- Registration date
- 25/04/2019
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 years 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 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 receive 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 January 2025
Who is funding the study?
1. Sahlgrenska University Hospital
2. Fredrik och Ingrid Thurings stiftelse
3. Svenska Spel's independent research council
Who is the main contact?
Anna Söderpalm Gordh
anna.soderpalm@neuro.gu.se
Contact information
Scientific
Mellangatan 1
Gothenburg
41301
Sweden
| Phone | +46 (0)734020237 |
|---|---|
| anna.soderpalm@neuro.gu.se |
Scientific
Mellangatan 1
Gothenburg
41301
Sweden
| Phone | +46 (0)700825194 |
|---|---|
| mikael.mide@vgregion.se |
Study information
| Study design | Single-center single-blinded interventional randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN38692394_PIS.pdf |
| Scientific title | Effectiveness of an internet-based cognitive behavioural treatment for disordered gamblers in a specialized outpatient setting: a randomised controlled trial |
| Study objectives | Current study hypothesis as of 07/12/2022: This study aims to assess whether an 8-week CBT-based treatment delivered over the internet can be effective for pathological gamblers (n=64) 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. Secondary hypothesis 3: Participants receiving the internet CBT treatment will display significant reductions in depressive and anxiety symptoms, and a significant increase in quality of life compared to participants in the control condition. Previous 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=84) 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Current primary outcome measure as of 07/12/2022: Gambling-related behaviour measured using the NODS: The NORC Diagnostic Screen for Gambling Problems (NODS) (Wickwire et al., 2008). 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. Previous 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 | Current secondary outcome measure as of 07/12/2022: 1. Gambling-related behaviour measured using the Time Line Follow Back (TLFB), adapted to measure pathological gambling (G-TLFB) (Hodgins & Makarchuk 2003) 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. 2. 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. 3. 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. 4. 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. 5. 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. Previous secondary outcome measure: 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 study start date | 30/06/2018 |
| Completion date | 31/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Recruitment will continue until 64 patients have been randomised and started the treatment. With 10% pre-treatment drop-out, we expect that a total of 72 randomised patients (36 per group) are needed |
| Total final enrolment | 71 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/05/2019 |
| Date of final enrolment | 30/11/2022 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Gothenburg
41345
Sweden
Sponsor information
Hospital/treatment centre
Addiction Clinic
Journalvägen 5
Sahlgrenska Universitetssjukhuset
Gothenburg
41345
Sweden
| Phone | +46 (0)313421000 |
|---|---|
| sahlgrenska.universitetssjukhuset@vgregion.se | |
"ROR" |
https://ror.org/04vgqjj36 |
Funders
Funder type
Hospital/treatment centre
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Fredrik and Ingrid Thurings Foundation
- Location
- Sweden
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Added 21/01/2025: Results have been published in 2023 (https://doi.org/10.3389/fpsyt.2023.1243826). The results of follow-up data will be published on approximately 30/06/2026. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 28/06/2022 | No | Yes | ||
| Statistical Analysis Plan | version 1.0 | 25/11/2022 | 07/12/2022 | No | No |
| Results article | 11/12/2023 | 27/12/2023 | Yes | No |
Additional files
Editorial Notes
21/01/2025: The publication and dissemination plan was updated. The intention to publish date was changed from 31/08/2023 to 30/06/2026.
27/12/2023: Publication reference added.
03/05/2023: The intention to publish date was changed from 31/05/2023 to 31/08/2023.
12/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/07/2023 to 30/11/2022.
2. The overall trial end date was changed from 31/08/2025 to 31/01/2025.
3. Total final enrolment added.
07/12/2022: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded.
2. The study hypothesis, primary and secondary outcome measures were updated.
3. The target number of participants was changed from "84" to "Recruitment will continue until 64 patients have been randomised and started the treatment. With 10% pre-treatment drop-out, we expect that a total of 72 randomised patients (36 per group) are needed".
04/07/2022: The following changes were made to the trial record:
1. The target number of participants was changed from 190 to 84.
2. The recruitment end date was changed from 31/12/2022 to 31/07/2023.
3. The overall trial end date was changed from 31/12/2024 to 31/08/2025.
4. Svenska spels independent research council was added as funder.
28/06/2022: The participant information sheet has been uploaded as an additional file.
25/04/2019: Trial's existence confirmed by the ethics board.
