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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19122
- Temple University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:認知行動療法
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Individual Therapy and Group Therapy
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アクティブコンパレータ:Guided Self Help
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Individual Therapy and Group Therapy
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アクティブコンパレータ:Dialectical Behavioral Therapy
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Individual Therapy and Group Therapy
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
時間枠:Up to 12 months after randomization
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Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
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Up to 12 months after randomization
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
むちゃ食い障害の臨床試験
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Western University, Canadaまだ募集していません
Therapyの臨床試験
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
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Universitätsklinikum Hamburg-Eppendorf完了
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Advanced Cooling Therapy, Inc., d/b/a Attune MedicalDnipropetrovsk State Medical Academy完了