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Effectiveness of Therapy Treatment

Primary Purpose

Gambling, Pathological Gambling

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Treatment as Usual
Cognitive Motivational Behavior Therapy
12-week wait list
Sponsored by
Problem Gambling Institute of Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling focused on measuring Gambling, Pathological Gambling

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Windsor Regional Hospital Problem Gambling ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Treatment As Usual

Cognitive Motivational Behavior Therapy

12-week wait list

Arm Description

The standard treatment usually provided at the clinic.

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

Participant will start treatment 12 weeks from day of consent.

Outcomes

Primary Outcome Measures

Changes in pathological gambling severity through treatment
Changes in problem gambling severity through follow-up

Secondary Outcome Measures

Examine putative mechanisms of action of "cognitive motivational behavior therapy" relative to "treatment as usual".
Assess treatment motivation, coping style, cognitive distortions, psychiatric severity and gambling self-efficacy before and after treatment.

Full Information

First Posted
April 26, 2012
Last Updated
January 10, 2017
Sponsor
Problem Gambling Institute of Ontario
Collaborators
Wayne State University, Windsor Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01596478
Brief Title
Effectiveness of Therapy Treatment
Official Title
Effectiveness of Cognitive-Motivational Behaviour Therapy in Community
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Problem Gambling Institute of Ontario
Collaborators
Wayne State University, Windsor Regional Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling, Pathological Gambling
Keywords
Gambling, Pathological Gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
The standard treatment usually provided at the clinic.
Arm Title
Cognitive Motivational Behavior Therapy
Arm Type
Active Comparator
Arm Description
An approach that addresses motivation to change gambling and behavioral patterns related to gambling.
Arm Title
12-week wait list
Arm Type
Active Comparator
Arm Description
Participant will start treatment 12 weeks from day of consent.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Participants will receive Treatment as Usual, on an individual basis, for 60-minutes once per week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Motivational Behavior Therapy
Intervention Description
Participants will receive a combined motivational and cognitive-behavioral therapy, on an individual basis, for 60-minutes once per week for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
12-week wait list
Intervention Description
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 Measure Information:
Title
Changes in pathological gambling severity through treatment
Time Frame
changes in gambling severity from baseline at post-treatment
Title
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 Measure Information:
Title
Examine putative mechanisms of action of "cognitive motivational behavior therapy" relative to "treatment as usual".
Description
Assess treatment motivation, coping style, cognitive distortions, psychiatric severity and gambling self-efficacy before and after treatment.
Time Frame
Baseline, and changes in gambling mechanisms of action from baseline at post-treatment, 6 and 12 months after beginning treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Sulkowski, B.S.
Phone
(313) 993-3966
Email
lsulkows@med.wayne.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ledgerwood, PhD
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Windsor Regional Hospital Problem Gambling Services
City
Windsor
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Ledgerwood, PhD

12. IPD Sharing Statement

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Effectiveness of Therapy Treatment

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