Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding

Sponsor

Hartford Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01451697

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hoarding Disorder Attentional Impairment	Behavioral: Cognitive Remediation Behavioral: Control (Placebo)	Early Phase 1

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding

Actual Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Continuous Performance Task (computerized version): change from Baseline in Attentional Functioning at 8 Weeks [Week 0 (Baseline) and Week 8 (Endpoint)]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anxiety Disorders Center, Institute of Living/Hartford	Hartford	Connecticut	United States	06106

Sponsors and Collaborators

Hartford Hospital

Investigators

Principal Investigator: Jennifer DiMauro, BA, Hartford Hospital
Study Director: David F Tolin, PhD, Hartford Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Hartford Hospital

ClinicalTrials.gov Identifier:

NCT01451697

Other Study ID Numbers:

DIMA003472HI

First Posted:

Oct 14, 2011

Last Update Posted:

May 20, 2019

Last Verified:

May 1, 2019

Additional relevant MeSH terms:

Hoarding Disorder

Study Results

No Results Posted as of May 20, 2019