- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00337753
Cognitive Behavioral Therapy for Pathological Gambling
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55454
- University of Minnesota Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Cognitive Behavioral Therapy
Weekly Cognitive Behavior therapy
|
5-weeks of Cognitive Behavioral Therapy
Andre navne:
|
|
Andet: Wait-list
Subjects in wait-list for six-weeks
|
subjects assigned to wait-list condition for six-weeks
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0503M68191
- K23MH069754-01A1 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .