Pathological GamblingNCT01743092
Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment
A study testing Webinar and Tutuorial workbook in people with Pathological Gambling, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Research specific to women's gambling treatment needs is limited but suggests a critical need for women sensitive options and reduced barriers to access. This pilot will test the effectiveness of a Tutorial Workbook (TW) both as a self-help tool and used in combination with a webinar. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Webinar and Tutuorial workbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological gamblers
- not currently in formal gambling specific treatment
- English proficiency (reading, writing and speech)
- access to private computer and phone
- sufficient computer skills to engage in webinar
- able to fully commit to time demands of weekly participation
Who cannot join
- active psychosis
- unstable mood disorders
- emotion dysregulation
- extreme social anxiety
- cognitive challenges in reading
- not proficient in in English (reading, writing and speech)
- suicidal behaviours
- current problems with drugs/ alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meeting the Unique Treatment Needs of Female Gamblers: A Workbook and Webinar Effectiveness Pilot Study
Research specific to women's gambling treatment needs is limited but suggests a critical need for women sensitive options and reduced barriers to access. This pilot will test the effectiveness of a Tutorial Workbook (TW) both as a self-help tool and used in combination with a webinar. Ontario women(n=48) over the age of 19, with gambling concerns, will be recruited through flyers, on-line and newspaper ads and randomly assigned to one of two groups: (a) TW or (b) TWW (TW plus Webinar). All will complete questionnaires addressing gambling behaviours, personal history and mood states prior to and after the 12 week study. Groups (a) and (b) will also provide feedback on the TW's content and relevance. Group (b) will, in addition, provide feedback on the Webinar Group. TW and TWW will be valuable additions to current treatments, of special importance to reduce barriers for women. The study will contribute to best practices in developing web-based treatments.
Read the detailed description
Most gambling specific research involves men yet findings are typically generalized to women, a shortcoming addressed in the literature. Women are underrepresented in treatment. A previous study (Boughton and Brewster, 2002) with 365 Ontario women not in treatment, explored barriers and treatment needs. Many respondents indicated that women-only groups and self-help materials would be of value. Using web-based resources to increase treatment options has merit in a growing technological age. This study will introduce two unique forms of treatment, a women friendly tutorial workbook developed specifically to address issues commonly underlying women's gambling and a webinar based group facilitated by a gambling clinician. Group support has been demonstrated to be highly beneficial for women in reducing isolation and shame. The research will assist in developing Best Practices in the problem gambling field, especially for women, a neglected and vulnerable group.
There are two questions:
- First, to what extent is the Tutorial Workbook effective by itself as a treatment option in helping women make changes to their gambling.
- What extent is the addition of the webinar discussion group option an incremental benefit to the participant in helping women make changes to their gambling.
Web based therapy has proven effective in the treatment of addiction and mental health issues but more research is needed to assess its efficacy for problem gambling. Self-help tools have been demonstrated as effective in reducing gambling but no women specific tools are available. Evidence of the effectiveness of the TW and TWW treatment options will reduce barriers for hard to serve populations of women and expand options for clinical programs to meet the needs of women unable to attend face to face programs. The TW attends to the unique issues and treatment/support needs of women with gambling concerns.
Ultimately the TW materials, once fully developed, can be made available to the general public as an online tool, used to assist n providing telephone counselling, individually or in a group (Webinar) format or be made available as a self-help paper based utorial workbook.
- Conditions
- Pathological Gambling
- Being tested
- Webinar, Tutuorial workbook
- Keywords
- Pathological gambling, treatment, online counselling, webinar, workbook
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WebinarBehavioural
Also called online discussion
Some clients will receive a webinar as part of their treatment.
Tutuorial workbookBehavioural
A work book about their addiciton
| Study group | Role | What they receive |
|---|---|---|
| Tutorial Workbook | Other | Tutorial Workbook Group only receives a Tutorial Workbook Group Receives: Behavioral: Tutuorial workbook |
| Tutorial Workbook Group plus webinar | Experimental | Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Receives: Behavioral: Webinar; Behavioral: Tutuorial workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale
The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one's life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress.
The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels.
Measured: 12 weeks
Secondary outcomes (1)
DASS Depression
The Depression, Anxiety and Stress Scale (DASS 21) is a 21 item self-report questionnaire developed by Lovibond, S.H. \& Lovibond, P.F. (1995, Manual for the Depression Anxiety Stress Scales, 2nd. Ed., Sydney: Psychology Foundation).
The range of total scores for each subscale is from 0 to 21. Higher values represent a worse outcome. Depression Normal 0-4 Mild 5-6 Moderate 7-10 Severe 11-13 Extremely Severe 14+ Anxiety Normal 0-3 Mild 4-5 Moderate 6-7 Severe 8-9 Extremely Severe 10+ Stress Normal 0-7 Mild 8-9 Moderate 10-12 Severe 13-16 Extremely Severe 17+
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nigel Turner, Centre for Addiction and Mental Health
- Investigators
- Nigel E Turner, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743092
- Sponsor's protocol ID
- 153-2012
- Status last verified
- Jan 2016
- First submitted
- 2 Nov 2012
- Last updated
- 1 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meeting the Unique Treatment Needs of Female Gamblers: A Workbook and Webinar Effectiveness Pilot Study
- ClinicalTrials.gov ID
- NCT01743092
- Acronym / sponsor ID
- 153-2012
- Conditions
- Pathological Gambling
- Keywords
- Pathological gambling, treatment, online counselling, webinar, workbook
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Posted 1 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research specific to women's gambling treatment needs is limited but suggests a critical need for women sensitive options and reduced barriers to access. This pilot will test the effectiveness of a Tutorial Workbook (TW) both as a self-help tool and used in combination with a webinar. Ontario women(n=48) over the age of 19, with gambling concerns, will be recruited through flyers, on-line and newspaper ads and randomly assigned to one of two groups: (a) TW or (b) TWW (TW plus Webinar). All will complete questionnaires addressing gambling behaviours, personal history and mood states prior to and after the 12 week study. Groups (a) and (b) will also provide feedback on the TW's content and relevance. Group (b) will, in addition, provide feedback on the Webinar Group. TW and TWW will be valuable additions to current treatments, of special importance to reduce barriers for women. The study will contribute to best practices in developing web-based treatments.
Detailed description
Most gambling specific research involves men yet findings are typically generalized to women, a shortcoming addressed in the literature. Women are underrepresented in treatment. A previous study (Boughton and Brewster, 2002) with 365 Ontario women not in treatment, explored barriers and treatment needs. Many respondents indicated that women-only groups and self-help materials would be of value. Using web-based resources to increase treatment options has merit in a growing technological age. This study will introduce two unique forms of treatment, a women friendly tutorial workbook developed specifically to address issues commonly underlying women's gambling and a webinar based group facilitated by a gambling clinician. Group support has been demonstrated to be highly beneficial for women in reducing isolation and shame. The research will assist in developing Best Practices in the problem gambling field, especially for women, a neglected and vulnerable group.
There are two questions:
- First, to what extent is the Tutorial Workbook effective by itself as a treatment option in helping women make changes to their gambling.
- What extent is the addition of the webinar discussion group option an incremental benefit to the participant in helping women make changes to their gambling.
Web based therapy has proven effective in the treatment of addiction and mental health issues but more research is needed to assess its efficacy for problem gambling. Self-help tools have been demonstrated as effective in reducing gambling but no women specific tools are available. Evidence of the effectiveness of the TW and TWW treatment options will reduce barriers for hard to serve populations of women and expand options for clinical programs to meet the needs of women unable to attend face to face programs. The TW attends to the unique issues and treatment/support needs of women with gambling concerns.
Ultimately the TW materials, once fully developed, can be made available to the general public as an online tool, used to assist n providing telephone counselling, individually or in a group (Webinar) format or be made available as a self-help paper based utorial workbook.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tutorial Workbook | Other | Behavioral: Tutuorial workbookTutorial Workbook Group only receives a Tutorial Workbook Group |
| Tutorial Workbook Group plus webinar | Experimental | Behavioral: Webinar, Behavioral: Tutuorial workbookTutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pathological gamblers
- not currently in formal gambling specific treatment
- English proficiency (reading, writing and speech)
- access to private computer and phone
- sufficient computer skills to engage in webinar
Key exclusion criteria (8 listed)
- active psychosis
- unstable mood disorders
- emotion dysregulation
- extreme social anxiety
- cognitive challenges in reading
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 |
|---|---|---|
| WebinarAlso: online discussionSome clients will receive a webinar as part of their treatment. | Behavioural | Tutorial Workbook Group plus webinar |
| Tutuorial workbookA work book about their addiciton | Behavioural | Tutorial Workbook, Tutorial Workbook Group plus webinar |
Primary outcome
Perceived Stress Scale
Time frame: 12 weeks
The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one's life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress. The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels.
1 secondary outcome
DASS Depression
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Website for the Problem Gambling Institute of Ontario and CAMH's problem gambling serviceLink provided by the sponsor.
Related trials for Pathological Gambling
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder
Not yet recruiting
COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL
Gambling Disorder
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.
Nigel E Turner, Ph.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Webinar and Tutuorial workbook in people with Pathological Gambling, run by Centre for Addiction and Mental Health 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 1 Apr 2016. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: 12 weeks). 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 1 Apr 2016.