Back to resultsMindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder
Primary Purpose
Gambling Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive-Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Gambling Disorder
Eligibility Criteria
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.
Sites / Locations
- Santa Creu i Sant Pau Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-Based Cognitive-Behavioral Therapy
Cognitive-Behavioral Therapy
Arm Description
Outcomes
Primary Outcome Measures
South Oaks Gambling Screen (SOGS; Lesieur and Blume, 1987)
DSM-IV-TR (APA 2000)
Difficulties in Emotion Regulation Scale (DERS, Gratz and Roemer, 2004)
Five Facets Mindfulness Questionnaire (FFMQ; Baer et al. 2006)
EQ-Decentering (Soler et al., 2014)
Gambling Related Cognitions Scale (GRCS; Raylu & Oei, 2004)
MBRP - Adherence and Competence Scale (Chawla et al. 2010
Secondary Outcome Measures
Temperament and Character Inventory-Revised (TCI-R; Cloninger 1999)
Symptom Checklist-Revised (SCL-90-R; Derogatis 1990)
UPPS (Whiteside and Lynam, 2001)
URICA - problem gambling (Gómez-Peña et al. 2011)
AUDIT (OMS, 1989)
DUDIT (Berman et al. 2003)
Full Information
NCT ID
NCT03497247
First Posted
April 6, 2018
Last Updated
April 6, 2018
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Spanish Clinical Research Network - SCReN
1. Study Identification
Unique Protocol Identification Number
NCT03497247
Brief Title
Mindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder
Official Title
Mindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
June 29, 2018 (Anticipated)
Study Completion Date
March 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Spanish Clinical Research Network - SCReN
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Cognitive-Behavioral Therapy
Arm Type
Experimental
Arm Title
Cognitive-Behavioral Therapy
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive-Behavioral Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
South Oaks Gambling Screen (SOGS; Lesieur and Blume, 1987)
Time Frame
5 minuts
Title
DSM-IV-TR (APA 2000)
Time Frame
5 minuts
Title
Difficulties in Emotion Regulation Scale (DERS, Gratz and Roemer, 2004)
Time Frame
5 minuts
Title
Five Facets Mindfulness Questionnaire (FFMQ; Baer et al. 2006)
Time Frame
5 minuts
Title
EQ-Decentering (Soler et al., 2014)
Time Frame
5 minuts
Title
Gambling Related Cognitions Scale (GRCS; Raylu & Oei, 2004)
Time Frame
5 minuts
Title
MBRP - Adherence and Competence Scale (Chawla et al. 2010
Time Frame
90 minuts (by co-therapist)
Secondary Outcome Measure Information:
Title
Temperament and Character Inventory-Revised (TCI-R; Cloninger 1999)
Time Frame
20 minuts
Title
Symptom Checklist-Revised (SCL-90-R; Derogatis 1990)
Time Frame
20 minuts
Title
UPPS (Whiteside and Lynam, 2001)
Time Frame
10 minuts
Title
URICA - problem gambling (Gómez-Peña et al. 2011)
Time Frame
10 minuts
Title
AUDIT (OMS, 1989)
Time Frame
5 minuts
Title
DUDIT (Berman et al. 2003)
Time Frame
5 minuts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Sancho, PhD
Organizational Affiliation
Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Creu i Sant Pau Hospital
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Mindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder
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