Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women
24 avril 2018 mis à jour par: Margit I. Berman, Dartmouth-Hitchcock Medical Center
Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women: A Randomized Controlled Trial
The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself!
compared to a commercial behavioral weight loss program, Weight Watchers (WW).
Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments.
Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
19
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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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03766
- Dartmouth-Hitchcock Medical Center
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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
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- English-speaking
- Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV)
- Body Mass Index (BMI) greater than or equal to 30
- Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study)
Exclusion Criteria:
- current substance dependence
- history of psychotic symptoms
- high risk of suicide/self-harm
- current enrollment in a weight-loss program
- weight loss surgery in the past year
- current psychotherapy
- inability to postpone weight loss or depression treatment interventions for the duration of the study
- taking antipsychotic, tricyclic, or oral corticosteroid medication
- unwilling to be randomized to the study treatments
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 |
|---|---|
|
Expérimental: Accept Yourself! Intervention
Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group
|
Autres noms:
|
|
Comparateur actif: Behavioral Weight Loss
Weight Watchers groups
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in clinician assessed depression symptoms
Délai: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
|
As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)
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At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
|
|
Change in self-reported depression symptoms
Délai: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
|
As assessed by Patient Health Questionnaire-9 (PHQ-9)
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in fasting Lipids
Délai: At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
|
At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.
|
|
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Change in systolic and diastolic blood pressure
Délai: At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
|
|
Change in fasting blood glucose
Délai: At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
|
|
Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)
Délai: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
|
|
Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)
Délai: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
|
|
Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)
Délai: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.
|
|
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Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)
Délai: At post-treatment (immediately following the three-month intervention)
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At post-treatment (immediately following the three-month intervention)
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|
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Change in weight
Délai: At post-treatment (immediately following the three-month intervention) and 12 month follow up
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Note that we are assessing weight change primarily as a safety measure (i.e., to demonstrate no significant weight gain in intervention group).
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At post-treatment (immediately following the three-month intervention) and 12 month follow up
|
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Change in self-reported physical activity
Délai: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
|
At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
|
|
|
Change in cardiovascular fitness as assessed by six-minute walk test
Délai: At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
|
At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Margit I Berman, Ph.D, Dartmouth College
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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)
12 août 2015
Achèvement primaire (Réel)
7 mai 2017
Achèvement de l'étude (Réel)
7 mai 2017
Dates d'inscription aux études
Première soumission
14 juillet 2015
Première soumission répondant aux critères de contrôle qualité
15 juillet 2015
Première publication (Estimation)
17 juillet 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 avril 2018
Dernière vérification
1 avril 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- D15151
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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 .
Essais cliniques sur Accept Yourself!
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Seattle Children's HospitalPatient-Centered Outcomes Research InstituteComplété
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Shahid Beheshti University of Medical SciencesComplétéCécité | Déficience visuelleIran (République islamique d