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Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding

Primary Purpose

Hoarding Disorder, Attentional Impairment

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation
Control (Placebo)
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hoarding Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anxiety Disorders Center, Institute of Living/Hartford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Cognitive Remediation

Control (Placebo)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Continuous Performance Task (computerized version): change from Baseline in Attentional Functioning at 8 Weeks
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).

Secondary Outcome Measures

Full Information

First Posted
October 10, 2011
Last Updated
May 17, 2019
Sponsor
Hartford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01451697
Brief Title
Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding
Official Title
Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hoarding Disorder, Attentional Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Cognitive Remediation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (Placebo)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Intervention Description
A computerized cognitive remediation program focused on attentional training will be used.
Intervention Type
Behavioral
Intervention Name(s)
Control (Placebo)
Intervention Description
The control condition will involve relaxation training.
Primary Outcome Measure Information:
Title
Continuous Performance Task (computerized version): change from Baseline in Attentional Functioning at 8 Weeks
Description
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).
Time Frame
Week 0 (Baseline) and Week 8 (Endpoint)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer DiMauro, BA
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David F Tolin, PhD
Organizational Affiliation
Hartford Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Anxiety Disorders Center, Institute of Living/Hartford
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

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Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding

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