Mindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder

April 6, 2018 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
To compare two group psychological interventions for Gambling Disorder in terms of effectiveness and efficacy. One group is based in cognitive-behavioral therapy (TAU) and the other group is based in TAU with Mindfulness-Based Relapse Prevention (Chawla, Marlatt & Gordon, 2011). Both interventions are composed by 14 weekly sessions, and follow-up to a month, three months, six months, one and two years.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Santa Creu i Sant Pau Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gambling Disorder (DSM-5; APA, 2013).
  • 18 years or older.
  • Males and females.

Exclusion Criteria:

  • Current psychosis or other severe/acute mental disorder.
  • Current substance abuse.
  • Intellectual disability.
  • Under 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cognitive-Behavioral Therapy
Behavioral: Mindfulness-Based Cognitive-Behavioral Therapy
Both arms have the same intervention techniques (relative intervention, stimulus control and others) except relapse prevention sessions. In the experimental arm, these sessions are carried out from Mindfulness, and in the active comparator is the usual relapse prevention.
Experimental: Mindfulness-Based Cognitive-Behavioral Therapy
Behavioral: Mindfulness-Based Cognitive-Behavioral Therapy
Both arms have the same intervention techniques (relative intervention, stimulus control and others) except relapse prevention sessions. In the experimental arm, these sessions are carried out from Mindfulness, and in the active comparator is the usual relapse prevention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
South Oaks Gambling Screen (SOGS; Lesieur and Blume, 1987)
Time Frame: 5 minuts
5 minuts
DSM-IV-TR (APA 2000)
Time Frame: 5 minuts
5 minuts
Difficulties in Emotion Regulation Scale (DERS, Gratz and Roemer, 2004)
Time Frame: 5 minuts
5 minuts
Five Facets Mindfulness Questionnaire (FFMQ; Baer et al. 2006)
Time Frame: 5 minuts
5 minuts
EQ-Decentering (Soler et al., 2014)
Time Frame: 5 minuts
5 minuts
Gambling Related Cognitions Scale (GRCS; Raylu & Oei, 2004)
Time Frame: 5 minuts
5 minuts
MBRP - Adherence and Competence Scale (Chawla et al. 2010
Time Frame: 90 minuts (by co-therapist)
90 minuts (by co-therapist)

Secondary Outcome Measures

Outcome Measure
Time Frame
Temperament and Character Inventory-Revised (TCI-R; Cloninger 1999)
Time Frame: 20 minuts
20 minuts
Symptom Checklist-Revised (SCL-90-R; Derogatis 1990)
Time Frame: 20 minuts
20 minuts
UPPS (Whiteside and Lynam, 2001)
Time Frame: 10 minuts
10 minuts
URICA - problem gambling (Gómez-Peña et al. 2011)
Time Frame: 10 minuts
10 minuts
AUDIT (OMS, 1989)
Time Frame: 5 minuts
5 minuts
DUDIT (Berman et al. 2003)
Time Frame: 5 minuts
5 minuts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Spanish Clinical Research Network - SCReN

Investigators

  • Principal Investigator: Marta Sancho, PhD, Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Anticipated)

June 29, 2018

Study Completion (Anticipated)

March 15, 2020

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TCC-2017-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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