Text Size

Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding

This study is currently recruiting participants.
Verified October 2011 by Hartford Hospital
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01451697
First received: October 10, 2011
Last updated: October 11, 2011
Last verified: October 2011
History of Changes
  Purpose

The primary aim of this pilot randomized controlled trial is to examine whether cognitive remediation, compared to a placebo, improves attention and related cognitive functions in patients with compulsive hoarding. The primary hypothesis is that compulsive hoarding patients who are treated with cognitive remediation will demonstrate improved cognitive skills at post-treatment compared to patients receiving placebo. This will be especially true of attention; memory and executive function skills may also be improved.


Condition Intervention Phase
Hoarding Disorder
Attentional Impairment
 Behavioral: Cognitive Remediation
Behavioral: Control (Placebo)
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding

Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Continuous Performance Task (computerized version): change from Baseline in Attentional Functioning at 8 Weeks [ Time Frame: Week 0 (Baseline) and Week 8 (Endpoint) ] [ Designated as safety issue: No ]
    This measure is a computerized assessment of attention, memory, and executive functioning. The investigators will use this measure to assess change in those cognitive domains between Baseline (Week 0) and Endpoint (Week 8).


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: Cognitive Remediation
The remediation intervention will consist of a sequence of computerized cognitive exercises designed to improve a variety of aspects of attention, through repeated drill-and-practice (Bell, Bryson, Greig, Corcoran, & Wexler, 2001; Bracy, 1995; Kurtz et al., 2007). Exercises will be started and continued at the highest level of difficulty, in order to best establish improvement over time. Components of the planned intervention produce performance gains on practiced tasks (e.g., Wexler et al., 1997) and generalization of improvement to other tasks (Kurtz et al., 2007). All training on computer exercises will be conducted with coaching from staff trained in these procedures.
 Behavioral: Cognitive Remediation
A computerized cognitive remediation program focused on attentional training will be used.
Placebo Comparator: Control (Placebo)
The placebo control condition will consist of structured relaxation training, which will involve viewing and participating with meditation and stress-reduction DVDs, and listening to and following a CD of Progressive Muscle Relaxation. Participants will benefit from learning stress reduction techniques in this condition, but will not exercise any of the cognitive domains of interest targeted in the treatment group.
 Behavioral: Control (Placebo)
The control condition will involve relaxation training.

Detailed Description:

The primary aim of this pilot randomized controlled trial is to examine whether cognitive remediation, compared to a placebo, improves attention and related cognitive functions in patients with compulsive hoarding. Previous research has demonstrated that hoarders have diminished neuropsychological abilities, particularly in the areas of attention, memory, and executive function; and that cognitive remediation improves those functions in populations that are similarly impaired, such as in individuals with schizophrenia. The investigators will thus randomize 20 patients with compulsive hoarding to receive either cognitive remediation or a placebo condition. Before and after treatment, the investigators aim to assess the effects of cognitive remediation on neuropsychological functioning and hoarding severity. The primary specific aim is to examine whether cognitive remediation improves cognitive function in compulsive hoarders. The investigators hypothesize that compulsive hoarding patients who are treated with cognitive remediation will demonstrate improved cognitive skills at post-treatment compared to patients receiving placebo. This will be especially true of attention; memory and executive function skills may also be improved. A secondary, exploratory aim is to examine whether cognitive remediation improves hoarding severity, compared to placebo. The ultimate goal of this research is to determine the feasibility and appropriateness of pursuing larger-scale studies of the promising new approach of combining cognitive remediation with other treatments for compulsive hoarding—particularly cognitive-behavioral therapy (CBT).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • be over 18 years of age,
  • have a current primary diagnosis of hoarding disorder
  • have no untreated and/or unstable concurrent psychiatric diagnoses
  • have a score on the ADHDSS that is one standard deviation or more above the mean
  • have an Attentional Composite score on the computerized battery of neuropsychological tests (Doniger, 2010) that is one standard deviation or more below the mean
  • be stable on all psychotropic medications during and up to four weeks preceding enrollment in the study

Exclusion Criteria:

  • currently taking any cognitive enhancers or stimulants
  • people with a history of Multiple Sclerosis, Traumatic Brain Injury, loss of consciousness lasting more than 5 minutes, seizures, dementia, or other organic brain-related disorders
  • current Alcohol or Substance Abuse and/or a history of Alcohol or Substance Dependence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451697

Contacts
Contact: Jennifer DiMauro, BA 860-545-7707 jdimauro@harthosp.org
Contact: David F Tolin, PhD 860-545-7685 dtolin@harthosp.org

Locations
United States, Connecticut
Anxiety Disorders Center, Institute of Living/Hartford Recruiting
Hartford, Connecticut, United States, 06106
Contact: Jennifer DiMauro, BA     860-545-7707     jdimauro@harthosp.org    
Contact: David F Tolin, PhD     860-545-7685     dtolin@harthosp.org    
Principal Investigator: Jennifer DiMauro, BA            
Sub-Investigator: David F Tolin, PhD            
Sub-Investigator: Johanna Kaplan, PhD            
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Jennifer DiMauro, BA Hartford Hospital
Study Director: David F Tolin, PhD Hartford Hospital
  More Information

Additional Information:
Anxiety Disorders Center's Hoarding Research page  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01451697     History of Changes
Other Study ID Numbers: DIMA003472HI
Study First Received: October 10, 2011
Last Updated: October 11, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 17, 2013