Trial record 3 of 13 for:    Open Studies | "Gambling"

Effectiveness of Therapy Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Wayne State University
Windsor Regional Hospital
Information provided by (Responsible Party):
David Ledgerwood, Wayne State University
ClinicalTrials.gov Identifier:
NCT01596478
First received: April 26, 2012
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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 Intervention
Gambling
Pathological Gambling
Behavioral: Treatment as Usual
Behavioral: Cognitive Motivational Behavior Therapy
Behavioral: 12-week wait list

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Cognitive-Motivational Behaviour Therapy in Community

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Changes in pathological gambling severity through treatment [ Time Frame: changes in gambling severity from baseline at post-treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assess treatment motivation, coping style, cognitive distortions, psychiatric severity and gambling self-efficacy before and after treatment.


Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596478

Contacts
Contact: Lisa Sulkowski, B.S. (313) 993-3966 lsulkows@med.wayne.edu

Locations
Canada, Ontario
Windsor Regional Hospital Problem Gambling Services Recruiting
Windsor, Ontario, Canada
Principal Investigator: David Ledgerwood, PhD         
Sponsors and Collaborators
Ontario Problem Gambling Research Centre
Wayne State University
Windsor Regional Hospital
Investigators
Principal Investigator: David Ledgerwood, PhD Wayne State University
  More Information

No publications provided

Responsible Party: David Ledgerwood, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01596478     History of Changes
Other Study ID Numbers: WSU-#080211M1F
Study First Received: April 26, 2012
Last Updated: May 9, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Gambling
Pathological Gambling

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014