- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01227057
Hoarding Older Adults
26. Juni 2018 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
58
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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California
-
San Diego, California, Vereinigte Staaten, 92161
- VA San Diego Healthcare System, San Diego, CA
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
60 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver Komparator: Arm 2: Case Management
Case management
|
Case management
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The Activities of Daily Living in Hoarding (ADL-H)
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Catherine R Ayers, PhD, VA San Diego Healthcare System, San Diego, CA
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2010
Primärer Abschluss (Tatsächlich)
1. April 2015
Studienabschluss (Tatsächlich)
1. April 2015
Studienanmeldedaten
Zuerst eingereicht
20. Oktober 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Oktober 2010
Zuerst gepostet (Schätzen)
22. Oktober 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
24. Juli 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Juni 2018
Zuletzt verifiziert
1. Juni 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- CSRD-068-10S
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