Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding

May 17, 2019 updated by: Hartford Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Anxiety Disorders Center, Institute of Living/Hartford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Continuous Performance Task (computerized version): change from Baseline in Attentional Functioning at 8 Weeks
Time Frame: 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).
Week 0 (Baseline) and Week 8 (Endpoint)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hartford Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer DiMauro, BA, Hartford Hospital
  • Study Director: David F Tolin, PhD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DIMA003472HI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hoarding Disorder

Clinical Trials on Cognitive Remediation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings