- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ontario
-
Toronto, Ontario, Kanada, M5S 2S1
- Problem Gambling Treatment Service
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Jiný: Tutorial Workbook
Tutorial Workbook Group only receives a Tutorial Workbook Group
|
A work book about their addiciton
|
Experimentální: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Perceived Stress Scale
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
DASS Depression
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Nigel E Turner, Ph.D., Centre for Addiction and Mental Health
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 153-2012
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Patologické hazardní hry
-
Centre Hospitalier Universitaire de NīmesNáborGambling DisorderFrancie
-
University of Maryland, BaltimoreDokončeno
-
Fondazione Novella FrondaUniversity of Padova; Istituto Italiano di Tecnologia; Casa di Cura Park Villa...Neznámý
-
Indonesia UniversityRadboud University Medical CenterZatím nenabíráme
-
Karolinska InstitutetDeakin UniversityNábor
-
University Hospital, LilleMinistry of Health, FranceZatím nenabírámeGambling DisorderFrancie
-
University of Sao PauloCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Dokončeno
-
Fundació Institut de Recerca de l'Hospital de la...Spanish Clinical Research Network - SCReNNeznámýGambling DisorderŠpanělsko
-
Karolinska InstitutetDokončeno
Klinické studie na Tutuorial workbook
-
Wilfrid Laurier UniversityDokončenoÚzkost | PlachostKanada
-
Stanford UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Southern... a další spolupracovníciNáborPití alkoholu | Porucha užívání alkoholu | Zneužití alkoholu | Vojenská rodina | Vztahy, mezilidskéSpojené státy