NCT05331612

Brief Summary

The main objective of present project is assess the preliminary efficacy of a blended psychological intervention, by comparing the improvements in the CBT and waiting list control groups of an evidence-based treatment protocol for problems related to gambling applied in a blended format (sessions through an online protocol treatment combining with face-to-face group sessions), as well as to evaluate the opinion and acceptance of the intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

March 1, 2022

Last Update Submit

June 13, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gambling Symptom Assessment Scale (Kim et al., 2009). At baseline, post-module, post-treatment, 3, 6 and 12 months follow-up.

    The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. All items are scored on a 4-point scale, and the score ranges from 0 to 48: extreme=41-48, severe=31-40, moderate=21-30 and mild=8-20. The scale shows a higher internal consistency (α = 0.82).

    Up to 12 months.

  • Gambling-related cognitions scale (Del Prete et al., 2017). At baseline, post-treatment, 3, 6 and 12 months follow-ups.

    The GRCS is a self-report which assessed the gambling cognitions through 23 items divided into 5 dimensions that are rated on a 7-point Likert-type scale (1 = I strongly disagree; 7 = I strongly agree). The reliability of each of the dimensions is adequate ID (α = 0.79), in adequate EJ (α = 0.72), in adequate CI (α = 0.7), in adequate PC (α = 0.73) and in good SI (α = 0.8). The degree of internal consistency of the total score of the scale was better (α = 0.9).

    Up to 12 months.

Secondary Outcomes (2)

  • Gambling Self-Efficacy Questionnaire (Winfree et al., 2013). At post-treatment, 3,6 and 12 months follow-ups.

    Up to 12 months.

  • The University of Rhode Island Change Assessment Scale (Gómez-Peña et al., 2011). At baseline, post-treatment, 3, 6 and 12 follow-ups.

    Up to 12 months.

Study Arms (2)

Blended intervention condition

EXPERIMENTAL

Blended intervention condition, consisting of 5 face-to-face group sessions lasting 2 hours every 2 weeks, alternated with the online treatment protocol carried out by the participants in a self-applied. The intervention has a period of duration of 13 weeks and it is composed by 8 modules (Motivation for change, Psychoeducation, Stimulus control, Cognitive restructuring, Urge surfing and emotion regulation, Planning of significant activities, Coping skills and exposure with response prevention, and Relapse prevention). These modules is based in the online platform and manualized protocol treatment "Sin jugar, ganas" (Díaz-Sanahuja et al., 2021).

Behavioral: Blended intervention condition

Waiting list control condition

NO INTERVENTION

Waiting list control group receives the blended treatment when the intervention has finished in the experimental group (blended group intervention).

Interventions

Participants receive the online protocol treatment and face-to-face sessions during 13 weeks.

Also known as: BI
Blended intervention condition

Eligibility Criteria

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

You may qualify if:

  • years or older.
  • Being able to understand, read and write Spanish.
  • Having a computer and daily access to the Internet at home.
  • Meeting criteria for gambling disorder or problem gambling according to the parameters established by the Norc Diagnostic Screening for gambling disorders (NODS) (Becoña, 2004),
  • Availability and willingness to provide information about gambling behavior in the follow-ups.

You may not qualify if:

  • Having any serious mental disorder.
  • If the behavior comes to maniac from a maniac episode or from taking antidepressants
  • Being high risk of suicide,
  • Moderate or severe alcohol and substance use disorder according to the Mini International Neuropsychiatric Interview (MINI) (Sheehan et al.,1998).
  • Any medical illness that conditions receiving treatment receives.
  • Increasing in the dose of pharmacological treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Jaume I

Castellon, Castelló, 12071, Spain

Location

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Juana Bretón López, Professor

    University Jaume I

    STUDY DIRECTOR

Central Study Contacts

Ainara Muñoz Ranchel, PhD Student

CONTACT

Adriana Mira Pastor, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

April 15, 2022

Study Start

October 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2024

Last Updated

June 16, 2022

Record last verified: 2022-06

Locations