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Gambling DisorderNCT03497247

Mindfulness-Based Cognitive-Behavioral Therapy for Gambling Disorder

A study testing Mindfulness-Based Cognitive-Behavioral Therapy in people with Gambling Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gambling Disorder
What is being tested?
Mindfulness-Based Cognitive-Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteSpain
Study dates
15 Mar 2018to 15 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Santa Creu i Sant Pau Hospital

    Barcelona, 08025

Other trials in Spain

About this study

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.

Being tested
Mindfulness-Based Cognitive-Behavioral Therapy
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Cognitive-Behavioral TherapyBehavioural

    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.

Study groups in NCT03497247
Study groupRoleWhat they receive
Mindfulness-Based Cognitive-Behavioral TherapyExperimentalNot described
Receives: Behavioral: Mindfulness-Based Cognitive-Behavioral Therapy
Cognitive-Behavioral TherapyActive comparatorNot described
Receives: Behavioral: Mindfulness-Based Cognitive-Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 minuts

  2. DSM-IV-TR (APA 2000)

    Measured: 5 minuts

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

    Measured: 5 minuts

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

    Measured: 5 minuts

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

    Measured: 5 minuts

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

    Measured: 5 minuts

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

    Measured: 90 minuts (by co-therapist)

Secondary outcomes (6)

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

    Measured: 20 minuts

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

    Measured: 20 minuts

  3. UPPS (Whiteside and Lynam, 2001)

    Measured: 10 minuts

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

    Measured: 10 minuts

  5. AUDIT (OMS, 1989)

    Measured: 5 minuts

  6. DUDIT (Berman et al. 2003)

    Measured: 5 minuts

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2018
  2. Study start15 Mar 2018
  3. Primary completion29 Jun 2018 (estimated)
  4. Study completion15 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03497247
Sponsor's protocol ID
IIBSP-TCC-2017-102
Status last verified
Apr 2018
First submitted
6 Apr 2018
Last updated
13 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Cognitive-Behavioral Therapy in people with Gambling Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

South Oaks Gambling Screen (SOGS; Lesieur and Blume, 1987) (time frame: 5 minuts). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03497247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.

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