NCT01596478

Brief Summary

The efficacy of psychosocial treatments for PG, including cognitive-behaviour therapy (CBT) and motivational interviewing (MI) approaches, has been supported in a handful of clinical trials. Indeed, there is more evidence supporting these two approaches than for any other psychosocial treatment for problem gambling. However, while efficacy studies have been conducted, few studies have examined the effectiveness of behavioural treatment in community-based gambling treatment settings. That is to say, the investigators have a good idea of what works in a laboratory setting (i.e., university research settings), but the investigators have no research assessing the transfer of evidence-based treatments for problem gambling to community care. Efficacy studies provide substantially less information about the actual utility of treatments than do effectiveness trials because the way in which treatment is actually provided in the field (with flexibility in terms of time-frame and technique and the tendency to address co-occurring problems) is different from the much more single-focused (on gambling) way it is conducted in laboratory settings. The proposed study is designed to address this significant gap in the research literature. The investigators propose to conduct a treatment effectiveness trial examining a combined cognitive motivational behavior therapy (CMBT) delivered by community-based problem gambling treatment providers, compared with treatment as usual (TAU).

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 11, 2017

Status Verified

May 1, 2012

Enrollment Period

2 years

First QC Date

April 26, 2012

Last Update Submit

January 10, 2017

Conditions

Keywords

GamblingPathological Gambling

Outcome Measures

Primary Outcomes (2)

  • Changes in pathological gambling severity through treatment

    changes in gambling severity from baseline at post-treatment

  • Changes in problem gambling severity through follow-up

    Changes in gambling severity from post-treatment through 6-month and 12-month follow-up periods

Secondary Outcomes (1)

  • Examine putative mechanisms of action of "cognitive motivational behavior therapy" relative to "treatment as usual".

    Baseline, and changes in gambling mechanisms of action from baseline at post-treatment, 6 and 12 months after beginning treatment

Study Arms (3)

Treatment As Usual

ACTIVE COMPARATOR

The standard treatment usually provided at the clinic.

Behavioral: Treatment as Usual

Cognitive Motivational Behavior Therapy

ACTIVE COMPARATOR

An approach that addresses motivation to change gambling and behavioral patterns related to gambling.

Behavioral: Cognitive Motivational Behavior Therapy

12-week wait list

ACTIVE COMPARATOR

Participant will start treatment 12 weeks from day of consent.

Behavioral: 12-week wait list

Interventions

Participants will receive Treatment as Usual, on an individual basis, for 60-minutes once per week for 12 weeks.

Treatment As Usual

Participants will receive a combined motivational and cognitive-behavioral therapy, on an individual basis, for 60-minutes once per week for 12 weeks.

Cognitive Motivational Behavior Therapy

Participants will be randomly assigned to start treatment immediately or to go on a 12-week wait list (where they will start treatment 12 weeks from day of consent).

12-week wait list

Eligibility Criteria

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

You may qualify if:

  • Main Study: Participants must score at least a 5 on the NODS, and have gambled in the previous two months. Participants must speak English and be able to provide informed consent.
  • Pilot Phase: Participants must be patients of the Problem Gambling Services at Windsor Regional Hospital.

You may not qualify if:

  • Main Study: Acute psychosis, mania or suicidality for which the participant needs immediate treatment, and current enrollment in formal problem gambling treatment (other than the current admission).
  • Participants with a co-occurring psychiatric or substance use condition will receive referrals to appropriate ancillary services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Windsor Regional Hospital Problem Gambling Services

Windsor, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Gambling

Interventions

TherapeuticsWaiting Lists

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • David Ledgerwood, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Sulkowski, B.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2012

First Posted

May 11, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 11, 2017

Record last verified: 2012-05

Locations