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.|
|ClinicalTrials.gov 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
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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).
- Changes in pathological gambling severity through treatment [ Time Frame: changes in gambling severity from baseline at post-treatment ]
- 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 ]
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01596478
|Contact: Lisa Sulkowski, B.S.||(313) email@example.com|
|Windsor Regional Hospital Problem Gambling Services||Recruiting|
|Windsor, Ontario, Canada|
|Principal Investigator: David Ledgerwood, PhD|
|Principal Investigator:||David Ledgerwood, PhD||Wayne State University|