Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment
Primary Purpose
Pathological Gambling
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Webinar
Tutuorial workbook
Sponsored by
About this trial
This is an interventional treatment trial for Pathological Gambling focused on measuring Pathological gambling, treatment, online counselling, webinar, workbook
Eligibility Criteria
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
Sites / Locations
- Problem Gambling Treatment Service
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Tutorial Workbook
Tutorial Workbook Group plus webinar
Arm Description
Tutorial Workbook Group only receives a Tutorial Workbook Group
Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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+
Full Information
NCT ID
NCT01743092
First Posted
November 2, 2012
Last Updated
March 10, 2016
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT01743092
Brief Title
Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment
Official Title
Meeting the Unique Treatment Needs of Female Gamblers: A Workbook and Webinar Effectiveness Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
Pathological gambling, treatment, online counselling, webinar, workbook
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tutorial Workbook
Arm Type
Other
Arm Description
Tutorial Workbook Group only receives a Tutorial Workbook Group
Arm Title
Tutorial Workbook Group plus webinar
Arm Type
Experimental
Arm Description
Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.
Intervention Type
Behavioral
Intervention Name(s)
Webinar
Other Intervention Name(s)
online discussion
Intervention Description
Some clients will receive a webinar as part of their treatment.
Intervention Type
Behavioral
Intervention Name(s)
Tutuorial workbook
Intervention Description
A work book about their addiciton
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
DASS Depression
Description
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+
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel E Turner, Ph.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Problem Gambling Treatment Service
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.problemgambling.ca
Description
Website for the Problem Gambling Institute of Ontario and CAMH's problem gambling service
Learn more about this trial
Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment
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