- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01227057
Hoarding Older Adults
26 juni 2018 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
58
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
California
-
San Diego, California, Verenigde Staten, 92161
- VA San Diego Healthcare System, San Diego, CA
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
60 jaar tot 85 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm 1: Cognitive Rehabilitation
Cognitive rehabilitation and exposure therapy for hoarding
|
The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
|
|
Actieve vergelijker: Arm 2: Case Management
Case management
|
Case management
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months
Tijdsspanne: 6 months
|
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.
|
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The Activities of Daily Living in Hoarding (ADL-H)
Tijdsspanne: 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.
|
6 months
|
|
Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months
Tijdsspanne: 6 months
|
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.
|
6 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Catherine R Ayers, PhD, VA San Diego Healthcare System, San Diego, CA
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2010
Primaire voltooiing (Werkelijk)
1 april 2015
Studie voltooiing (Werkelijk)
1 april 2015
Studieregistratiedata
Eerst ingediend
20 oktober 2010
Eerst ingediend dat voldeed aan de QC-criteria
20 oktober 2010
Eerst geplaatst (Schatting)
22 oktober 2010
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 juli 2018
Laatste update ingediend die voldeed aan QC-criteria
26 juni 2018
Laatst geverifieerd
1 juni 2018
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- CSRD-068-10S
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .