Efficacy of an Internet-based Psychological Intervention for Problem Gambling and Gambling Disorder

Universitat Jaume I

Status: Not yet enrolling

Conditions: Pathological Gambling

Treatments: Behavioral: Gambling Internet-based Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04074681

UJI-A2016-14

Details and patient eligibility

About

The aim of this study is to assess the efficacy of an online CBT-based intervention combined with an Ecological Momentary Intervention (EMI) and different complementary tools for the treatment of problem gambling and gambling disorder. The main hypothesis is that the Internet-based psychological intervention group will obtain better results than the waiting list control group.

Full description

Gambling Disorder is a prevalent non-substance use disorder, which contrasts with the low number of people requesting treatment. Information and Communication Technologies (ICT) could help to enhance the dissemination of evidence-based treatments and considerably reduce the costs. The current study seeks to assess the efficacy of an online psychological intervention for people suffering from gambling problems in Spain. The proposed study will be a two-arm, parallel-group, randomized controlled trial. A total of 134 participants (problem and pathological gamblers) will be randomly allocated to a waiting list control group (N=67) or an intervention group (N=67). The intervention program includes 8 modules, and it is based on motivational interviewing, cognitive-behavioural therapy (CBT), and extensions and innovations of CBT. It includes several complementary tools that are present throughout the entire intervention. Therapeutic support will be provided once a week through a phone call with a maximum length of 10 minutes. The primary outcome measure will be gambling severity and gambling-related cognitions, and secondary outcome measures will be readiness to change, and gambling self-efficacy. Other variables that will be considered are depression and anxiety symptoms, positive and negative affect, difficulties in emotion regulation strategies, impulsivity, and quality of life. Individuals will be assessed at baseline, post-treatment, and 3-, 6-, and 12-month follow-ups. During the treatment, participants will also respond to a daily Ecological Momentary Intervention (EMI) in order to evaluate urges to gamble, self-efficacy to cope with gambling urges, gambling urge frequency, and whether gambling behaviour occurs. The EMI includes immediate automatic feedback depending on the participant's responses. Treatment acceptance and satisfaction will also be assessed. The data will be analysed both per protocol and by Intention-to-treat. As far as we know, this is the first randomized controlled trial of an online psychological intervention for gambling disorder in Spain. It will expand our knowledge about treatments delivered via the Internet and contribute to improving treatment dissemination, reaching people suffering from this problem who otherwise would not receive help.

Enrollment: 134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be 18 years or older.
• Willingness to participate in the study and sign informed consent.
• To have and handle the computer, Internet and an email address.
• Ability to understand, read and write Spanish.
• Based on the cut-off points established by the Norc diagnostic screen for gambling disorders (NODS; adapted by Becoña, 2004): be a problem gambler (3-4 items) or a pathological gambler (5 or more items).
• Willingness to provide the name of a co-therapist to validate the information provided, as well as to be able to locate the patient in follow-ups.
• Willing to provide follow-up data on gambling.

Exclusion criteria

• Any serious mental disorder (Bipolar and Related Disorders and Schizophrenia Spectrum and Other Psychotic Disorders), medical illness, and moderate or severe alcohol and/or substance use disorder, that prevents the program from being carried out.
• If their gambling behaviour occurs in the context of a Maniac Episode or because of the intake of dopaminergic medication (e.g. Parkinson's disease).
• The presence of high suicidal risk.
• Receiving another psychological treatment while the study is still ongoing.
• Receiving pharmacological treatment is not an exclusion criterion during the study period, but participants having an increase and/or change in the medication 2 months prior to enrollment will not be considered for the trial. Also, the increase and/or change in the medication during the study period in the experimental group will imply the participant's exclusion from subsequent analyses (a decrease in pharmacological treatment is accepted).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Gambling Internet-based Protocol

Experimental group

Description:

Intervention group that carries out the Gambling Internet-based Protocol based on Cognitive and Behavioral Therapy (CBT) and receives support by the therapist (a weekly 10-minute phone call without clinical content). In addition, they will receive one notification per day to respond to the EMI questions at 8 PM. The EMI includes immediate automatic feedback depending on the participant's responses.

Treatment:

Behavioral: Gambling Internet-based Protocol

Waiting List Control Group

No Intervention group

Description:

Participants in a 12-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the waiting list period.