- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00965705
Stepped Care Treatment for Binge-Eating
Dialectical Behavior Therapy for Early Non-Responders to CBT
Temple University is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder.
Binge-Eating Disorder is a significant public health problem for women. Despite this, there is limited research on how best to treat this disorder at varying levels of severity. The purpose of this NIMH-funded study is to enroll individuals in a brief form of cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been adapted for women living with binge-eating disorder and are free of charge.
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19122
- Temple University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult female, 18 years to 60 years
- Meets DSM-IV criteria for Binge Eating Disorder
- Resides within commuting distance
- Consents to research protocol, i.e.
- 18-24 months in assessment and treatment
- willing to be part of a biological assessment/physiological assessment
- have to be prepared that they will receive a brief individual treatment and if this does not work for them, that they will receive more intensive treatment including both group and individual treatment.
- agreement not to see other health professionals unless recommended
- seeing their own Primary care Physician/Nurse Practitioner for medical screening prior to study (i.e., before being allocated a guided self-help therapist)
- payment for their own medical assessment, monitoring, and medication if needed
Exclusion Criteria:
- Anorexia nervosa
- Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS, or Bipolar Mood Disorder
- Needs priority treatment for other debilitating conditions, e.g. current substance dependence requiring inpatient detox
- chronic absence of shelter
- IQ less than 70
- Impending jail/prison, court order to treatment, court order to treatment or to jail, or agency order to treatment or to loss of child custody (due to consequent inability to freely drop-out of treatment)
- Is pregnant, plans to become pregnant during treatment, or becomes pregnant before random assignment to study condition
- Medical instability
- Has had or is seeking Gastric bypass surgery
- On anti-seizure medication, beta-blockers, asthma medication, medication for heart disease, or any other medication that affects appetite or weight
- Psychotropics are acceptable if the doses are stable for at least 3 months prior to screening
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Kognitiv beteendeterapi
|
Individual Therapy and Group Therapy
|
|
Aktiv komparator: Guided Self Help
|
Individual Therapy and Group Therapy
|
|
Aktiv komparator: Dialectical Behavioral Therapy
|
Individual Therapy and Group Therapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Tidsram: Up to 12 months after randomization
|
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
|
Up to 12 months after randomization
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- Chen EY, Cacioppo J, Fettich K, Gallop R, McCloskey MS, Olino T, Zeffiro TA. An adaptive randomized trial of dialectical behavior therapy and cognitive behavior therapy for binge-eating. Psychol Med. 2017 Mar;47(4):703-717. doi: 10.1017/S0033291716002543. Epub 2016 Nov 17.
- Southward MW, Christensen KA, Fettich KC, Weissman J, Berona J, Chen EY. Loneliness mediates the relationship between emotion dysregulation and bulimia nervosa/binge eating disorder psychopathology in a clinical sample. Eat Weight Disord. 2014 Dec;19(4):509-13. doi: 10.1007/s40519-013-0083-2.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20472 (Annan identifierare: City of Hope Comprehensive Cancer Center)
- K23MH081030-01 (U.S.S. NIH-anslag/kontrakt)
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