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Status unknownNCT03497247Updated Apr 13, 2018

Mindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder

An interventional study of Mindfulness-Based Cognitive-Behavioral Therapy in Gambling Disorder, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-13.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gambling Disorder

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Current psychosis or other severe/acute mental disorder.
  • Current substance abuse.
  • Intellectual disability.
  • Under 18 years.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Mindfulness-Based Cognitive-Behavioral Therapy

    Behavioral: Mindfulness-Based Cognitive-Behavioral Therapy

  • Active comparator
    Cognitive-Behavioral Therapy

    Behavioral: Mindfulness-Based Cognitive-Behavioral Therapy

Interventions

  • BehavioralMindfulness-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.

05

What researchers measure

Primary outcomes

  1. South Oaks Gambling Screen (SOGS; Lesieur and Blume, 1987)

    Time frame: 5 minuts

  2. DSM-IV-TR (APA 2000)

    Time frame: 5 minuts

  3. Difficulties in Emotion Regulation Scale (DERS, Gratz and Roemer, 2004)

    Time frame: 5 minuts

  4. Five Facets Mindfulness Questionnaire (FFMQ; Baer et al. 2006)

    Time frame: 5 minuts

  5. EQ-Decentering (Soler et al., 2014)

    Time frame: 5 minuts

  6. Gambling Related Cognitions Scale (GRCS; Raylu & Oei, 2004)

    Time frame: 5 minuts

  7. MBRP - Adherence and Competence Scale (Chawla et al. 2010

    Time frame: 90 minuts (by co-therapist)

Secondary outcomes

  1. Temperament and Character Inventory-Revised (TCI-R; Cloninger 1999)

    Time frame: 20 minuts

  2. Symptom Checklist-Revised (SCL-90-R; Derogatis 1990)

    Time frame: 20 minuts

  3. UPPS (Whiteside and Lynam, 2001)

    Time frame: 10 minuts

  4. URICA - problem gambling (Gómez-Peña et al. 2011)

    Time frame: 10 minuts

  5. AUDIT (OMS, 1989)

    Time frame: 5 minuts

  6. DUDIT (Berman et al. 2003)

    Time frame: 5 minuts

06

Study locations

1 site
  • Santa Creu i Sant Pau Hospital
    Barcelona, 08025, Spain
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03497247
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Spanish Clinical Research Network - SCReN
Responsible party
Sponsor
First posted
Apr 13, 2018
Start date
Mar 15, 2018
Primary completion
Jun 29, 2018 (estimated)
Completion
Mar 15, 2020 (estimated)
Last update
Apr 13, 2018

Study contacts

Marta Sancho, PhD
principal investigator · Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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