Effectiveness of Therapy Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01596478
Recruitment Status : Unknown
Verified May 2012 by , Wayne State University.
Recruitment status was:  Recruiting
First Posted : May 11, 2012
Last Update Posted : January 11, 2017
Wayne State University
Windsor Regional Hospital
Information provided by (Responsible Party):
, Wayne State University

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).

Condition or disease Intervention/treatment Phase
Gambling Pathological Gambling Behavioral: Treatment as Usual Behavioral: Cognitive Motivational Behavior Therapy Behavioral: 12-week wait list Not Applicable

Detailed Description:

Pilot Study: Eligible participants will undergo a full consent process and a brief interview to assess demographics. Participants' counselors will be asked to audio-record up to 3 therapy sessions which will subsequently be rated for adherence to CMBT procedures.

Main Study: Eligible participants will undergo a full consent process followed by an in-depth interview, with a research assistant. Following an intake assessment, participants will be randomly assigned to one of the three intervention groups. Randomization also will be balanced based on gender to ensure an equitable distribution of men and women in each condition. The research assistant will give the treatment referrals and will introduce the participant to his/her therapist as appropriate.

Treatment will be provided by clinicians at the Windsor Regional Problem Gambling Services.

  • Treatment as usual (TAU) - Therapists will be instructed to conduct therapy as they normally would with PGs entering treatment.
  • Cognitive motivational behaviour therapy (CMBT) Therapy will consist of 12 60-minute individual counselling sessions. The cognitive-behavioural portion of the intervention is targeted at addressing gambling-related cognitive distortions (e.g., the idea that the gambler can control random events). Motivational interviewing techniques are included to address participant ambivalence about his/her gambling.

Approximately 8 therapists will provide treatment (4 CMBT and 4 TAU, randomly assigned using flip of a coin.) The therapists enrolled in CMBT will be trained for the study. TAU therapists will be offered training in CMBT once study recruitment goals have been met (thus, eventually all therapists will receive training in CMBT). Prior to providing treatment, therapists selected to administer CMBT will receive intensive training in administration of this approach. The therapists will be selected from the professional staff of the Windsor Regional Hospital's Problem Gambling Services.

-Waitlist control condition (WLC) - WLC participants will wait 12-weeks to begin treatment.

At that point, participants will be randomly assigned to receive TAU or CMBT and will proceed through the same study phase (i.e., treatment and follow-up).

Participants will undergo assessments at intake, post-treatment, 6- and 12-months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Cognitive-Motivational Behaviour Therapy in Community
Study Start Date : December 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Treatment As Usual
The standard treatment usually provided at the clinic.
Behavioral: Treatment as Usual
Participants will receive Treatment as Usual, on an individual basis, for 60-minutes once per week for 12 weeks.

Active Comparator: Cognitive Motivational Behavior Therapy
An approach that addresses motivation to change gambling and behavioral patterns related to gambling.
Behavioral: Cognitive Motivational Behavior Therapy
Participants will receive a combined motivational and cognitive-behavioral therapy, on an individual basis, for 60-minutes once per week for 12 weeks.

Active Comparator: 12-week wait list
Participant will start treatment 12 weeks from day of consent.
Behavioral: 12-week wait list
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).

Primary Outcome Measures :
  1. Changes in pathological gambling severity through treatment [ Time Frame: changes in gambling severity from baseline at post-treatment ]
  2. Changes in problem gambling severity through follow-up [ Time Frame: Changes in gambling severity from post-treatment through 6-month and 12-month follow-up periods ]

Secondary Outcome Measures :
  1. Examine putative mechanisms of action of "cognitive motivational behavior therapy" relative to "treatment as usual". [ Time Frame: Baseline, and changes in gambling mechanisms of action from baseline at post-treatment, 6 and 12 months after beginning treatment ]
    Assess treatment motivation, coping style, cognitive distortions, psychiatric severity and gambling self-efficacy before and after treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01596478

Contact: Lisa Sulkowski, B.S. (313) 993-3966

Canada, Ontario
Windsor Regional Hospital Problem Gambling Services Recruiting
Windsor, Ontario, Canada
Principal Investigator: David Ledgerwood, PhD         
Sponsors and Collaborators
Problem Gambling Institute of Ontario
Wayne State University
Windsor Regional Hospital
Principal Investigator: David Ledgerwood, PhD Wayne State University

Responsible Party: , Assistant Professor, Wayne State University Identifier: NCT01596478     History of Changes
Other Study ID Numbers: WSU-#080211M1F
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: May 2012

Keywords provided by , Wayne State University:
Pathological Gambling

Additional relevant MeSH terms:
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders