NCT03497247

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.

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
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

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

Study Start

First participant enrolled

March 15, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

4 months

First QC Date

April 6, 2018

Last Update Submit

April 6, 2018

Conditions

Outcome Measures

Primary Outcomes (7)

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

    5 minuts

  • DSM-IV-TR (APA 2000)

    5 minuts

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

    5 minuts

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

    5 minuts

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

    5 minuts

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

    5 minuts

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

    90 minuts (by co-therapist)

Secondary Outcomes (6)

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

    20 minuts

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

    20 minuts

  • UPPS (Whiteside and Lynam, 2001)

    10 minuts

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

    10 minuts

  • AUDIT (OMS, 1989)

    5 minuts

  • +1 more secondary outcomes

Study Arms (2)

Mindfulness-Based Cognitive-Behavioral Therapy

EXPERIMENTAL
Behavioral: Mindfulness-Based Cognitive-Behavioral Therapy

Cognitive-Behavioral Therapy

ACTIVE COMPARATOR
Behavioral: Mindfulness-Based Cognitive-Behavioral Therapy

Interventions

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.

Cognitive-Behavioral TherapyMindfulness-Based Cognitive-Behavioral Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Creu i Sant Pau Hospital

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Marta Sancho, PhD

    Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

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

April 6, 2018

First Posted

April 13, 2018

Study Start

March 15, 2018

Primary Completion

June 29, 2018

Study Completion

March 15, 2020

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations