- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01227057
Hoarding Older Adults
26 juin 2018 mis à jour par: VA Office of Research and Development
Treatment of Late Life Compulsive Hoarding
The purpose of this investigation is to examine treatment outcome of a new intervention for hoarding in older adults compared to standard case management for hoarding.
The new intervention combines exposure therapy and cognitive remediation.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Research has shown that hoarding disorder (HD) is debilitating chronic and progressive condition that has significant public health implications.
Older adults represent the largest group of HD suffers due to increasing severity with age.
Often, Veterans with HD are seen in the VA system and the status of their hoarding is never assessed.
Providers are treating patients for other health and social service issues yet missing an important source of disability and distress.
This insidious, often undetected condition leads to greater medical and social disability and is costly to the VA system as patients continue to decompensate.
When HD is even detected, patients in the VA receive indefinite case management and inadequate treatment.
The cases the investigators know about have caused significant financial burden to the investigators' system.
Most importantly, HD causes significant impairment and poor quality of life for the Veterans, particularly older Veterans.
Unfortunately, the investigators know nothing about how to treat late life HD.
Nor do the investigators know how neurocognitive features impact treatment response, which the investigators strongly suspect influence treatment outcome.
HD is a potentially treatable source of disability in the VA system - one that the VA must research and treat.
This study represents the first randomized controlled trial of a novel intervention for the treatment of HD in older Veterans.
The main objective of this proposal is to further refine and test a new treatment for hoarding in older Veterans (age 60-85) which will be accomplished through a series of treatment development phases (case series, open labeled trial) and a randomized controlled trial.
The new treatment (Cognitive Remediation and Exposure Therapy for hoarding; CogRET) is hypothesis driven and based on late life anxiety literature, consultation with mentors, results of the pilot study using a standard cognitive-behavioral intervention, and several case series that will be completed prior to the start of the Career Development Award (CDA).
The first draft of CogRET is complete and is currently being used with several case studies.
The research and training plan is divided into 5 phases; 1) training and preparation 2) training, further case studies using CogRET, further modification of CogRET 3)training, open label trial of CogRET, further modification of CogRET 4) randomized controlled trial and 5) presenting, publishing, dissemination of results and submission of a VA Merit grant.
Primary hypotheses include 1) when randomized to CogRET, older Veterans with HD will show significant decreases in acquisition, difficulty discarding, and excessive clutter compared to those randomized to case management and 2) executive functioning (EF) is a significant moderator of treatment response.
Other mediators and moderates of treatment response (psychiatric, medical, demographic, etc.) will be explored.
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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California
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San Diego, California, États-Unis, 92161
- VA San Diego Healthcare System, San Diego, CA
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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
60 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Participants must be between the ages of 60 - 85 years old and meet clinical criteria for Compulsive Hoarding (CH) developed by the Steketee and Frost (2000) research group. These criteria include:
- significant amount of clutter in active living spaces
- the urge to collect, buy, or acquire things
- an extreme reluctance to part with items
- clutter accumulation that causes distress or interferes with functioning
- symptom duration of at least 6 months
- the reluctance to part with items is not accounted for by other psychiatric conditions.
To be enrolled, patients must have:
- a score of 20 or greater on the University of California, Los Angeles Hoarding Severity Scale (UHSS)
- 40 or greater on the Savings Inventory-Revised (SI-R)
- severity rating of 4 or higher on the Anxiety Disorders Interview Schedule (ADIS-IV) rating scales for clutter and difficulty discarding
- and diagnosis confirmed at a consensus conference including at least two licensed professionals with expertise in CH (myself and at least one mentor).
Exclusion Criteria:
- Individuals with moderate to severe cognitive deficits (scores below 23 on the MMSE) will be excluded.
- Prospective participants must not have active substance abuse problems.
- Participants will also be excluded if they are currently in other forms of psychotherapy.
- Participants must have no change in any psychotropic medications for at least three months prior to the initial assessment.
- Patients with current psychosis or mania will be excluded.
- Mood and anxiety disorders are permitted as long as compulsive hoarding is the primary diagnosis.
- Participants will are not eligible if they have active suicidal ideation, those participants will be given immediate medical or mental health attention.
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: Arm 1: Cognitive Rehabilitation
Cognitive rehabilitation and exposure therapy for hoarding
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The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
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Comparateur actif: Arm 2: Case Management
Case management
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Case management
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months
Délai: 6 months
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Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R), a 23-item self-report measure used to assess common hoarding symptoms.
Subtests include excessive clutter, compulsive acquisition, and difficulty discarding.
The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, divergent validity, test-retest reliability in clinical samples with hoarding.
The total score will be used for analyses.
The range of the total score is 0-92, with higher scores indicating worse hoarding severity.
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Activities of Daily Living in Hoarding (ADL-H)
Délai: 6 months
|
The Activities of Daily Living in Hoarding (ADL-H) was used to assess functional impairment.
Higher scores represent increased impairment.
Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.
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6 months
|
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Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months
Délai: 6 months
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The D-KEFS Trail Making Test Condition 4: Number-Letter Switching Scaled Score was used to assess executive functioning.
Scaled scores range from 1-19.
Higher scores represent less impairment.
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6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Catherine R Ayers, PhD, VA San Diego Healthcare System, San Diego, CA
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
1 novembre 2010
Achèvement primaire (Réel)
1 avril 2015
Achèvement de l'étude (Réel)
1 avril 2015
Dates d'inscription aux études
Première soumission
20 octobre 2010
Première soumission répondant aux critères de contrôle qualité
20 octobre 2010
Première publication (Estimation)
22 octobre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
24 juillet 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2018
Dernière vérification
1 juin 2018
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CSRD-068-10S
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 .