GamblingNCT01596478
Effectiveness of Therapy Treatment
A study testing Treatment as Usual, Cognitive Motivational Behavior Therapy and 12-week wait list in people with Gambling and Pathological Gambling, run by Problem Gambling Institute of Ontario at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gambling, Pathological Gambling
- What is being tested?
- Treatment as Usual, Cognitive Motivational Behavior Therapy and 12-week wait list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Windsor Regional Hospital Problem Gambling Services
Windsor, Ontario
David Ledgerwood, PhD
About this study
Official title: Effectiveness of Cognitive-Motivational Behaviour Therapy in Community
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).
Read the 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.
- Conditions
- Gambling, Pathological Gambling
- Being tested
- Treatment as Usual, Cognitive Motivational Behavior Therapy, 12-week wait list
- Keywords
- Gambling, Pathological Gambling
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as UsualBehavioural
Participants will receive Treatment as Usual, on an individual basis, for 60-minutes once per week for 12 weeks.
Cognitive Motivational Behavior TherapyBehavioural
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 listBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual | Active comparator | The standard treatment usually provided at the clinic. Receives: Behavioral: Treatment as Usual |
| Cognitive Motivational Behavior Therapy | Active comparator | An approach that addresses motivation to change gambling and behavioral patterns related to gambling. Receives: Behavioral: Cognitive Motivational Behavior Therapy |
| 12-week wait list | Active comparator | Participant will start treatment 12 weeks from day of consent. Receives: Behavioral: 12-week wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pathological gambling severity through treatment
Measured: changes in gambling severity from baseline at post-treatment
Changes in problem gambling severity through follow-up
Measured: Changes in gambling severity from post-treatment through 6-month and 12-month follow-up periods
Secondary outcomes (1)
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.
Measured: Baseline, and changes in gambling mechanisms of action from baseline at post-treatment, 6 and 12 months after beginning treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Problem Gambling Institute of Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University, Windsor Regional Hospital
- Responsible party
- Principal investigator, Wayne State University
- Investigators
- David Ledgerwood, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596478
- Sponsor's protocol ID
- WSU-#080211M1F
- Status last verified
- May 2012
- First submitted
- 26 Apr 2012
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive-Motivational Behaviour Therapy in Community
- ClinicalTrials.gov ID
- NCT01596478
- Acronym / sponsor ID
- WSU-#080211M1F
- Conditions
- Gambling, Pathological Gambling
- Keywords
- Gambling, Pathological Gambling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Problem Gambling Institute of OntarioUniversity, hospital or other
- Collaborators
- Wayne State University, Windsor Regional Hospital
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 11 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual | Active comparator | Behavioral: Treatment as UsualThe standard treatment usually provided at the clinic. |
| Cognitive Motivational Behavior Therapy | Active comparator | Behavioral: Cognitive Motivational Behavior TherapyAn approach that addresses motivation to change gambling and behavioral patterns related to gambling. |
| 12-week wait list | Active comparator | Behavioral: 12-week wait listParticipant will start treatment 12 weeks from day of consent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as UsualParticipants will receive Treatment as Usual, on an individual basis, for 60-minutes once per week for 12 weeks. | Behavioural | Treatment As Usual |
| Cognitive Motivational Behavior TherapyParticipants will receive a combined motivational and cognitive-behavioral therapy, on an individual basis, for 60-minutes once per week for 12 weeks. | Behavioural | Cognitive Motivational Behavior Therapy |
| 12-week wait listParticipants 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). | Behavioural | 12-week wait list |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ledgerwood, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as Usual, Cognitive Motivational Behavior Therapy and 12-week wait list in people with Gambling and Pathological Gambling, run by Problem Gambling Institute of Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Sulkowski, B.S. ((313) 993-3966, lsulkows@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pathological gambling severity through treatment (time frame: changes in gambling severity from baseline at post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.