- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00337753
Cognitive Behavioral Therapy for Pathological Gambling
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Subjects will be assigned to counseling or be given a referral list of available Gamblers Anonymous meetings at the first visit based on answers to questions. Assignment to counseling or Gamblers Anonymous will be randomly selected (i.e. chance) with an equal chance of receiving either one. For those assigned to counseling, you will meet with the therapist for 60 minutes weekly. You will receive 5 sessions of counseling.
All subjects will be assessed with gambling questionnaires twice during the 5-week period and again at 3 and 6 months following the 5-week period.
For those assigned to Gamblers Anonymous, they will be offered 5 weeks of counseling at the end of the 6-month follow-up.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater, 55454
- University of Minnesota Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Outpatient men and women age 18 to 75
- Presence of current DSM-IV pathological gambling for at least 6 months duration
- PG is the most problematic psychiatric disorder (in the patient's and clinician's opinion) and the primary reason for seeking treatment
- Minimum score of >5 on the South Oaks Gambling Screen which reflects gambling severity consistent with pathological gambling
Exclusion Criteria:
- Current clinically significant suicidality, severe depression (a score of ≥ 19 on the Hamilton Rating Scale for Depression, 17-item version)(30) or any other disorder requiring immediate intervention
- Presence of any clinical features requiring a higher level of care than outpatient treatment
- Cognitive impairment that interferes with the capacity to engage in CBT or to provide informed consent
- DSM-IV substance abuse or dependence within the past 3 months (see Screening Visit)
- Current Axis I diagnosis of bipolar disorder or psychotic disorder
- Previous treatment of CBT for PG (duration of at least 6 sessions); because CBT is not widely used for PG, a minimum of 6 treatments will be rare.
- Current use of psychotropic medications or within 2 months prior to study entry.
- Current participation in Gambler's Anonymous (GA).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Cognitive Behavioral Therapy
Weekly Cognitive Behavior therapy
|
5-weeks of Cognitive Behavioral Therapy
Andre navn:
|
|
Annen: Wait-list
Subjects in wait-list for six-weeks
|
subjects assigned to wait-list condition for six-weeks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
PG-YBOCS
Tidsramme: At each visit prior to and after therapy has been completed
|
At each visit prior to and after therapy has been completed
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time spent gambling
Tidsramme: At each visit prior to and after therapy has been completed
|
At each visit prior to and after therapy has been completed
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0503M68191
- K23MH069754-01A1 (U.S. NIH-stipend/kontrakt)
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