Effectiveness of Therapy Treatment

Pathological Gambling Clinical Trial

Official title:

Effectiveness of Cognitive-Motivational Behaviour Therapy in Community

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01596478
• Other study ID #: WSU-#080211M1F
• Status: Unknown status
• Phase: N/A
• First received: April 26, 2012
• Last updated: January 10, 2017
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2012
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling

Intervention

Behavioral:
• Treatment as Usual
Participants will receive Treatment as Usual, on an individual basis, for 60-minutes once per week for 12 weeks.
• 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.
• 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).

Locations

Country	Name	City	State
Canada	Windsor Regional Hospital Problem Gambling Services	Windsor	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Problem Gambling Institute of Ontario	Wayne State University, Windsor Regional Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pathological gambling severity through treatment		changes in gambling severity from baseline at post-treatment	No
Primary	Changes in problem gambling severity through follow-up		Changes in gambling severity from post-treatment through 6-month and 12-month follow-up periods	No
Secondary	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.	Baseline, and changes in gambling mechanisms of action from baseline at post-treatment, 6 and 12 months after beginning treatment	No