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Hoarding Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01227057
First received: October 20, 2010
Last updated: July 20, 2016
Last verified: July 2016
Results First Received: March 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Compulsive Hoarding
Interventions: Behavioral: Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding
Behavioral: Case Management

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Cognitive Rehabilitation

Cognitive rehabilitation and exposure therapy for hoarding

Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.

Arm 2: Case Management Case Management: Case management

Participant Flow:   Overall Study
    Arm 1: Cognitive Rehabilitation   Arm 2: Case Management
STARTED   31   27 
COMPLETED   25   19 
NOT COMPLETED   6   8 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1: Cognitive Rehabilitation

Cognitive rehabilitation and exposure therapy for hoarding

Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.

Arm 2: Case Management Case Management: Case management
Total Total of all reporting groups

Baseline Measures
   Arm 1: Cognitive Rehabilitation   Arm 2: Case Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   27   58 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.35  (6.49)   64.19  (5.35)   66.95  (6.48) 
Gender 
[Units: Participants]
     
Female   24   17   41 
Male   7   10   17 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   0   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   0   1 
White   27   24   51 
More than one race   0   3   3 
Unknown or Not Reported   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   31   27   58 
Saving Inventory Revised [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 57.35  (10.23)   59.48  (14.01)   58.34  (12.08) 
[1] Total score is 0-92, with higher scores indicating worse hoarding severity.
Clutter Image Rating [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.15  (1.71)   4.33  (2.11)   4.24  (1.89) 
[1] Mean score is 1-9, with higher scores indicating worse clutter severity.
University of California, Los Angeles Hoarding Severity Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 26.35  (5.31)   28.85  (5.82)   27.52  (5.65) 
[1] Total score is 0-40, with higher scores indicating worse hoarding severity.
Activities of Daily Living - Hoarding [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 30.85  (9.3)   31.90  (13.53)   31.31  (11.23) 
[1] Mean score is 1-75, with higher scores indicating worse impairment due to hoarding.
Hospital Anxiety and Depression [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Hospital Anxiety and Depression - Anxiety   9.06  (4.39)   10.15  (3.41)   9.56  (3.98) 
Hospital Anxiety and Depression - Depression   7.13  (3.23)   8.56  (4.97)   7.79  (4.16) 
[1] Total score for each subscale is 0-21, with higher scores indicating worse anxiety or depression severity.
Clinician Global Improvement - Severity scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.67  (.92)   3.96  (1.19)   3.81  (1.06) 
[1] Total score is 1-7, with higher scores indicating worse severity of mental illness.


  Outcome Measures
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1.  Primary:   Hoarding Symptom Severity as Measured by the Saving Inventory-Revised (SI-R) at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Executive Functioning as Measured by the Delis Kaplan Executive Functioning System (D-KEFS) at 6 Months   [ Time Frame: 6 months ]

3.  Secondary:   Change in Functional Impairment as Measured by the Activities of Daily Living, Functional Disability Index, Clutter Image Rating Scale   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was under-powered to fully detect the differences between CREST and Case Management.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Catherine Ayers
Organization: VASDHS
phone: 8585528585 ext 2976
e-mail: catherine.ayers1@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01227057     History of Changes
Other Study ID Numbers: CSRD-068-10S
Study First Received: October 20, 2010
Results First Received: March 11, 2016
Last Updated: July 20, 2016
Health Authority: United States: Federal Government