Effectiveness of the ECHOs Approach for Patients With Eating Disorders and Their Carers (ECHO)
2018年7月16日 更新者：Aaron Keshen、Nova Scotia Health Authority
Effectiveness of the Expert Carers Helping Others (ECHOs) Approach for Patients With Eating Disorders and Their Carers
Family therapy is considered an empirically supported treatment approach for adolescents and adults with eating disorders.
One family based approach, Expert Carers Helping Others (ECHO) is based on evidence that suggests family environment, e.g., carer criticism, can influence an individual's eating disorder symptoms.
ECHO aims to improve carer coping, reduce expressed emotion and manage eating disorder symptoms, and has been associated with reduced carer distress, caregiver burden, and an increase in general well being.
The current pilot study seeks to evaluate a new condensed version of the ECHO intervention that is delivered entirely in a 2 ½ hour self-help DVD format (ECHOs).
Sixty patients and their carers will be recruited from the Capital Health Eating Disorders Service and randomized into either a treatment as usual group (TAU) or a TAU+ECHOs group.
Both carers and patients will be assessed along a variety of dimensions including psychiatric symptoms, family functioning, and carer and patient collaboration, at pre-intervention, four weeks later at post-intervention, and then three-months post-intervention.
ANOVAs will be used to compare the primary outcomes between the two groups over time.
This pilot study will be the first evaluation of ECHOs, which may ultimately boost the efficacy of current treatment for adults with eating disorders and reduce carer distress.
調査の概要
研究の種類
介入
入学 (実際)
58
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Nova Scotia
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Halifax、Nova Scotia、カナダ、B3H2E2
- Capital Health District Health Authority
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
17年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients with an ED (AN, BN, EDNOS) according to DSM-V criteria (American Psychiatric Association, 2013) as determined by standard clinical interview completed by team psychiatrist or clinical psychologist.
- Patients age of >17y.o.
- Carers can include parents/partners/siblings/extended family who provide unpaid help and support. Peers and roommates could also be included in circumstances within which they play a significant role in the person's life and meet the following criteria:
- Live with or have regular, current contact with the patient (at least 7 hours/week) throughout the duration of the trial (approximately 6months).
- Interact with the patient in some meaningful manner regarding their ED (e.g. provide support, eat meals together, discussions about behaviours).
- Consent from patient and at least one carer
Exclusion Criteria:
- ED comorbid with severe psychiatric or physical comorbidity: e.g. current psychotic illness (inc. bipolar disorder), severe alcohol/drug abuse, significant metabolic or gastrointestinal problems (i.e. treatment interfering) as determined by standard clinical interview completed by team psychiatrist or clinical psychologist.
- Family in a concurrent treatment trial.
- Either patient or carer has insufficient knowledge of English.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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実験的：Expert Cares Helping Others plus Treatment as Usual
The experimental treatment (ECHOs plus TAU) will consist of the standard treatment consisting of group psychotherapy and skills training, nutritional counselling, and meal support, PLUS self-help unguided DVD series for carers, providing education about eating disorders and coping strategies for supporting those living with eating disorders.
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A self-help DVD that provides information for carers on eating disorders and teaches coping strategies to carers.
他の名前：
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アクティブコンパレータ：Treatment as Usual
Treatment as usual (TAU) consists of group psychotherapy and skills training, nutritional counselling, and meal support.
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Treatment as Usual at the Eating Disorder Services includes group psychotherapy and skills training, nutritional counselling, and meal support.
他の名前：
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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 |
|---|---|---|
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Changes in Carer and Patient Collaboration Scale (CPCS).
時間枠：baseline, 4-weeks post-intervention, 3 months follow-up
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A scale to assess self efficacy in caregiving, specifically tailored to measure the skills taught in the ECHOs intervention.
This scale will assess changes from baseline to post-internvention in caregiver efficacy.
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baseline, 4-weeks post-intervention, 3 months follow-up
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Changes in Short Evaluation of Eating Disorders (SEED)
時間枠：baseline, 4-weeks post-intervention, 3 months follow-up
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This measure will asssess changes in the severity of key anorexic and bulimic symptoms from baseline to post-treatment, and follow-up.
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baseline, 4-weeks post-intervention, 3 months follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depression, Stress and Anxiety Scale (DASS-21)
時間枠：baseline, 4-weeks post-intervention, 3 months follow-up
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a measure of severity of anxiety, depression and stress pre- to post-treatment
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baseline, 4-weeks post-intervention, 3 months follow-up
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The Family Questionnaire (FQ)
時間枠：baseline, 4-weeks post-intervention, 3 months follow-up
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20-item self report measure of expressed emotion in carers.
Scores are given on a 4-point Likert scale and will measure the levels of expressed emotion from pre-intervention to post-intervention.
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baseline, 4-weeks post-intervention, 3 months follow-up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年4月1日
一次修了 (実際)
2017年12月1日
研究の完了 (実際)
2017年12月1日
試験登録日
最初に提出
2013年8月15日
QC基準を満たした最初の提出物
2013年8月21日
最初の投稿 (見積もり)
2013年8月22日
学習記録の更新
投稿された最後の更新 (実際)
2018年7月17日
QC基準を満たした最後の更新が送信されました
2018年7月16日
最終確認日
2018年7月1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。
摂食障害の臨床試験
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Western University, Canadaまだ募集していません
ECHOs plus TAUの臨床試験
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Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de Barcelona; Ministerio de Ciencia e Innovación, Spainまだ募集していません
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Neudive Inc.募集
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Hospital Universitari Vall d'Hebron Research InstituteParc Sanitari Sant Joan de Déu; Universitat Autonoma de Barcelona完了
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Michele StatonNational Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)招待による登録
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Hospital Universitari Vall d'Hebron Research Institute積極的、募集していない
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University of Wisconsin, MadisonMedical University of South Carolina; National Heart, Lung, and Blood Institute (NHLBI)完了
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Hospital Universitari Vall d'Hebron Research InstituteUniversitat Autonoma de Barcelona募集