- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01743092
Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment
Meeting the Unique Treatment Needs of Female Gamblers: A Workbook and Webinar Effectiveness Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2S1
- Problem Gambling Treatment Service
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Tutorial Workbook
Tutorial Workbook Group only receives a Tutorial Workbook Group
|
A work book about their addiciton
|
|
Experimental: Tutorial Workbook Group plus webinar
Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.
|
A work book about their addiciton
Some clients will receive a webinar as part of their treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DASS Depression
Time Frame: 12 weeks
|
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+ |
12 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nigel E Turner, Ph.D., Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 153-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pathological Gambling
-
University of Nevada, Las VegasNot yet recruitingGambling Disorder | Pathological Gambling | Problem Gambling | Behavioral AddictionUnited States
-
Université Catholique de LouvainCentre Hospitalier Universitaire Vaudois; Cliniques universitaires Saint-Luc-... and other collaboratorsUnknownCraving | Gambling | Gambling Disorder | Gambling, Pathological | Gambling ProblemSwitzerland
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedGambling | Pathological Gambling | Problem GamblingUnited States
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingAccelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial (arTMSinGD)Gambling | Gambling Disorder | Gambling, Pathological | Gambling Problem
-
University of ChicagoCompleted
-
Finnish Institute for Health and WelfareUnknownNaloxone | Gambling Disorder | Opioid Antagonist | Pathological GamblingFinland
-
Emalex Biosciences Inc.Psyadon PharmaCompletedPathological GamblingUnited States
-
University of California, San FranciscoNational Center for Responsible GamingCompletedPathological Gambling
-
Universitätsklinikum Hamburg-EppendorfCompletedGambling, PathologicalGermany
-
University of IowaForest Laboratories; University of NebraskaCompletedPathological Gambling
Clinical Trials on Tutuorial workbook
-
The University of Tennessee, KnoxvilleBreast Cancer Research FoundationActive, not recruitingBreast Cancer | Gynecologic Cancer | Sexual Dysfunction | Partner CommunicationUnited States
-
Northwestern UniversityCompletedDisorder Related to Renal Transplantation | Unspecified Complications of Kidney TransplantUnited States
-
Limbic LimitedCompletedMental Health IssueUnited Kingdom
-
Emory UniversityGeorgia Center for Diabetes Translation ResearchCompleted
-
City University of Hong KongStanford University; Harvard UniversityCompletedMental Health WellnessColombia, Indonesia, South Africa, Ukraine
-
Weill Medical College of Cornell UniversityUniversity of Iowa; National Institute on Aging (NIA); Cornell University; Rutgers...TerminatedChronic Pain | DementiaUnited States
-
Talaria, IncNational Cancer Institute (NCI)CompletedBreast CancerUnited States