- ICH GCP
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- Essai clinique NCT01927042
Effectiveness of the ECHOs Approach for Patients With Eating Disorders and Their Carers (ECHO)
16 juillet 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
58
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H2E2
- Capital Health District Health Authority
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
17 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Comparateur actif: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Carer and Patient Collaboration Scale (CPCS).
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Depression, Stress and Anxiety Scale (DASS-21)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2014
Achèvement primaire (Réel)
1 décembre 2017
Achèvement de l'étude (Réel)
1 décembre 2017
Dates d'inscription aux études
Première soumission
15 août 2013
Première soumission répondant aux critères de contrôle qualité
21 août 2013
Première publication (Estimation)
22 août 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juillet 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juillet 2018
Dernière vérification
1 juillet 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 59093005
- 59095003 (Autre identifiant: Capital Health)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .