Dialectical Behavior Therapy for Early Non-Responders to CBT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cognitive Behavioral Therapy
干预措施: Therapy (Behavioral)
Dialectical Behavioral Therapy
干预措施: Therapy (Behavioral)
Guided Self Help
干预措施: Therapy (Behavioral)
结局指标
主要结局
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
时间窗: 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
次要结局
未报告次要终点
研究者
Eunice Chen
Study Principal Investigator
Temple University