Clinical trial NCT01596478: Effectiveness of Therapy Treatment
Official title: Effectiveness of Cognitive-Motivational Behaviour Therapy in Community
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gambling
Pathological Gambling
Keywords: Gambling
Pathological Gambling
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Wayne State University
name: Windsor Regional Hospital
First posted: 2012-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in pathological gambling severity through treatment
timeFrame: changes in gambling severity from baseline at post-treatment
measure: Changes in problem gambling severity through follow-up
timeFrame: Changes in gambling severity from post-treatment through 6-month and 12-month follow-up periods
Secondary outcomes:
measure: Examine putative mechanisms of action of "cognitive motivational behavior therapy" relative to "treatment as usual".
timeFrame: Baseline, and changes in gambling mechanisms of action from baseline at post-treatment, 6 and 12 months after beginning treatment
Other outcomes:
Locations:
city: Windsor
country: Canada
facility: Windsor Regional Hospital Problem Gambling Services
state: Ontario
Study officials:
affiliation: Wayne State University
name: David Ledgerwood, PhD
role: PRINCIPAL_INVESTIGATOR
References: