- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01135264
Cognitive-Motivational Behavior Therapy for Pathological Gamblers
Gambling Addiction: Treatment Mediators and Moderators
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
CMBT has been developed by our team over the last five years, and has shown very promising results in a small, NIMH-funded randomized pilot trial (R21 MH 064568). We will assess patients biweekly during the active treatment phase and follow them for 12 months after the end of treatment to obtain data on long-term treatment outcome. We hypothesize that CMBT will show higher efficacy and retention than CBT in the treatment phase, and that gains will be maintained at a higher rate during follow-up.
A second major purpose of the proposed study is to elucidate the presumed mechanisms of change by examining potential mediators (readiness to change, irrational beliefs about gambling, coping skills, therapeutic alliance) and moderators (psychiatric comorbidity with Axis I and II disorders, family history of PG, impulsivity, and baseline motivation to change) of treatment response. A better understanding of how the proposed interventions work will help advance the science and treatment of PG and will be helpful in the future refinement and adaptation of CMBT. Identifying patient subgroups for which the intervention is particularly effective is essential for rational treatment selection. Thus, the immediate goal of the project is to compare CBMT versus CBT for the treatment of PG. A long-term goal of the proposed research is to establish effective treatment procedures that reduce the considerable individual and social costs of PG.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
New York
-
New York, New York, Verenigde Staten, 10032
- New York Psychiatric Institute
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- pathological gambling
- be able to read, understand and sign an informed consent form prior to any procedure and must be willing to comply with all study procedures and timelines
Exclusion Criteria:
- to meet DSM-IV criteria for comorbid substance use disorders in the last six months
- current comorbid psychiatric conditions which require treatment and are not clearly secondary to pathological gambling
- psychotropic medication
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: CBT
The CBT treatment developed by Ladouceur (Consultant) will serve as control condition (outline of published treatment manual by Ladouceur & Lachance, 2006.
This treatment served as a model for the cognitive-behavioral component in CMBT and has received empirical support in two studies from Ladouceur's lab (Sylvain et al., 1997; Ladouceur et al., 2004).
It places strong emphasis on cognitive correction of erroneous beliefs about gambling and also focuses on coping skills training and relapse prevention.
CBT also lasts 12 weekly sessions.
|
The CBT treatment developed by Ladouceur (Consultant) will serve as control condition (outline of published treatment manual by Ladouceur & Lachance, 2006.
This treatment served as a model for the cognitive-behavioral component in CMBT and has received empirical support in two studies from Ladouceur's lab (Sylvain et al., 1997; Ladouceur et al., 2004).
It places strong emphasis on cognitive correction of erroneous beliefs about gambling and also focuses on coping skills training and relapse prevention.
CBT also lasts 12 weekly sessions.
|
Experimenteel: CMBT
We used the NIMH-funded R21 mechanism to develop and test the CMBT intervention (Wulfert et al., 2003, 2005; 2006).
Treatment will be implemented in 12 weekly sessions (3 motivational enhancement sessions, 8 sessions of cognitive-behavioral treatment, 1 session of relapse prevention)
|
We used the NIMH-funded R21 mechanism to develop and test the CMBT intervention (Wulfert et al., 2003, 2005; 2006).
Treatment will be implemented in 12 weekly sessions (3 motivational enhancement sessions, 8 sessions of cognitive-behavioral treatment, 1 session of relapse prevention)
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
patient retention
Tijdsspanne: 60 weeks
|
Retention will be measured by the number of treatment sessions attended
|
60 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
gambling behavior
Tijdsspanne: 60 weeks
|
Our primary measure will be money lost gambling.
Secondary measures will include days gambled; scores on the PG-YBOCS, proportion of patients meeting diagnosis of PG and of those having achieved abstinence.
|
60 weeks
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Carlos Blanco, M.D., New York Psychiatric Institute
Publicaties en nuttige links
Algemene publicaties
- Blanco C, Potenza MN, Kim SW, Ibanez A, Zaninelli R, Saiz-Ruiz J, Grant JE. A pilot study of impulsivity and compulsivity in pathological gambling. Psychiatry Res. 2009 May 15;167(1-2):161-8. doi: 10.1016/j.psychres.2008.04.023. Epub 2009 Apr 1.
- Blanco C, Hasin DS, Petry N, Stinson FS, Grant BF. Sex differences in subclinical and DSM-IV pathological gambling: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Psychol Med. 2006 Jul;36(7):943-53. doi: 10.1017/S0033291706007410. Epub 2006 May 2.
- Okuda M, Balan I, Petry NM, Oquendo M, Blanco C. Cognitive-behavioral therapy for pathological gambling: cultural considerations. Am J Psychiatry. 2009 Dec;166(12):1325-30. doi: 10.1176/appi.ajp.2009.08081235.
- Wulfert E, Blanchard EB, Freidenberg BM, Martell RS. Retaining pathological gamblers in cognitive behavior therapy through motivational enhancement: A pilot study. Behav Modif. 2006 May;30(3):315-40. doi: 10.1177/0145445503262578.
- Wulfert E, Maxson J, Jardin B. Cue-specific reactivity in experienced gamblers. Psychol Addict Behav. 2009 Dec;23(4):731-5. doi: 10.1037/a0017134.
- Wulfert E, Franco C, Williams K, Roland B, Maxson JH. The role of money in the excitement of gambling. Psychol Addict Behav. 2008 Sep;22(3):380-390. doi: 10.1037/0893-164X.22.3.380.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- #5946/6970R
- 1R01MH082773-01A1 (Subsidie/contract van de Amerikaanse NIH)
- 1R01MH082733-01A1 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op CBT
-
National Institute of Diabetes and Digestive and...Voltooid
-
VA Office of Research and DevelopmentCorporal Michael J. Crescenz VA Medical CenterWerving
-
Iowa State UniversityNational Institute of Mental Health (NIMH)Werving
-
Dr. Nazanin AlaviOnline PsychoTherapy ClinicVoltooidErnstige depressieve stoornisCanada
-
Psychiatric Research Unit, Region Zealand, DenmarkAarhus University Hospital; University of Copenhagen; Mental Health Centre CopenhagenVoltooidPaniekstoornis | Depressie, unipolair | Angststoornis SociaalDenemarken
-
NMP Medical Research InstituteWarwick Research ServicesVoltooidHuiselijk geweld | Emotionele mishandeling | Psychische mishandeling van volwassenenIndië
-
Toronto Rehabilitation InstituteOnbekend
-
Drexel UniversityNational Institute of Mental Health (NIMH)VoltooidBoulimia | Boulimia nervosa | Eetbuien | Eetstoornis | ZuiverenVerenigde Staten
-
Massachusetts General HospitalActief, niet wervendDepressie | Obsessief-compulsieve stoornis | Gegeneraliseerde angststoornis | Aandachtstekortstoornis met hyperactiviteit | Trichotillomanie | Paniekstoornis | Sociale angst | Specifieke fobie | Tourette syndroom | Post-traumatische stress-stoornis | Lichaamsdysmorfe stoornis | Eetstoornis | Algemene medische...Verenigde Staten
-
Stony Brook UniversityNational Institute for Occupational Safety and Health (NIOSH/CDC)VoltooidTekenen en symptomen, ademhaling | Post-traumatische stress-stoornis | Sigaretten rokenVerenigde Staten