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Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nigel Turner, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01743092
First received: November 2, 2012
Last updated: March 10, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Pathological Gambling
Behavioral: Webinar
Behavioral: Tutuorial workbook

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Meeting the Unique Treatment Needs of Female Gamblers: A Workbook and Webinar Effectiveness Pilot Study

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Perceived Stress Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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+



Enrollment: 59
Study Start Date: November 2012
Study Completion Date: August 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tutorial Workbook
Tutorial Workbook Group only receives a Tutorial Workbook Group
Behavioral: Tutuorial workbook
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.
Behavioral: Webinar
Some clients will receive a webinar as part of their treatment.
Other Name: online discussion
Behavioral: Tutuorial workbook
A work book about their addiciton

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:

  1. First, to what extent is the Tutorial Workbook effective by itself as a treatment option in helping women make changes to their gambling.
  2. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743092

Locations
Canada, Ontario
Problem Gambling Treatment Service
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Nigel E Turner, Ph.D. Centre for Addiction and Mental Health
  More Information

Additional Information:
Responsible Party: Nigel Turner, Independent Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01743092     History of Changes
Other Study ID Numbers: 153-2012 
Study First Received: November 2, 2012
Results First Received: October 14, 2015
Last Updated: March 10, 2016
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
Pathological gambling
treatment
online counselling
webinar
workbook

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 07, 2016