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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03497247
Other study ID # IIBSP-TCC-2017-102
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 6, 2018
Last updated April 6, 2018
Start date March 15, 2018
Est. completion date March 15, 2020

Study information

Verified date April 2018
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 18
Est. completion date March 15, 2020
Est. primary completion date June 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain Santa Creu i Sant Pau Hospital Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Spanish Clinical Research Network - CAIBER

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary South Oaks Gambling Screen (SOGS; Lesieur and Blume, 1987) 5 minuts
Primary DSM-IV-TR (APA 2000) 5 minuts
Primary Difficulties in Emotion Regulation Scale (DERS, Gratz and Roemer, 2004) 5 minuts
Primary Five Facets Mindfulness Questionnaire (FFMQ; Baer et al. 2006) 5 minuts
Primary EQ-Decentering (Soler et al., 2014) 5 minuts
Primary Gambling Related Cognitions Scale (GRCS; Raylu & Oei, 2004) 5 minuts
Primary MBRP - Adherence and Competence Scale (Chawla et al. 2010 90 minuts (by co-therapist)
Secondary Temperament and Character Inventory-Revised (TCI-R; Cloninger 1999) 20 minuts
Secondary Symptom Checklist-Revised (SCL-90-R; Derogatis 1990) 20 minuts
Secondary UPPS (Whiteside and Lynam, 2001) 10 minuts
Secondary URICA - problem gambling (Gómez-Peña et al. 2011) 10 minuts
Secondary AUDIT (OMS, 1989) 5 minuts
Secondary DUDIT (Berman et al. 2003) 5 minuts
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