Neural Mechanisms of CBT Response in Hoarding Disorder

August 5, 2019 updated by: David Tolin, Hartford Hospital
The purpose of this research is to measure changes in brain activity with functional magnetic resonance imaging (fMRI) before and after cognitive-behavioral therapy for compulsive hoarding. Cognitive-behavioral therapy aims to help people change the thoughts and behaviors that maintain symptoms of hoarding. The investigators intend to enroll approximately 80 people with hoarding disorder and 40 people with no psychiatric disorder, between the ages of 20 and 60, for this study. The investigators believe that after treatment there will be changes in the brain activity of individuals with compulsive hoarding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long-term goal of the proposed research is to improve clinical outcomes for Hoarding Disorder (HD), a common and potentially debilitating condition that poses a severe public health burden. The PI has developed and tested a cognitive-behavioral therapy (CBT) that appears moderately effective, although there is clear room for improvement. In the present study, the investigators propose to merge this line of research with the PI's recent NIH-supported neuroimaging research that points to specific functional abnormalities in regions of interest (ROIs) related to cognitive and affective decisionmaking processes. Patients with HD n = 80) will be randomized to CBT or wait list (WL). At pre-treatment, mid-treatment, and post-treatment, patients will undergo functional magnetic resonance imaging (fMRI) during an acquiring and discarding decision-making task that has been used successfully in the investigators' previous work. In addition, patients will complete a number of laboratory tasks designed to assess decision-making capacity and impairment. A group of healthy control (HC) participants (n = 40) will also complete these measures as a normative control group. The primary aim of the proposed study is to determine the extent to which the observed patterns of neural activity in HD change following CBT. Under this aim, the investigators predict that HD patients (vs.HCs) will show greater hemodynamic activity in ROIs associated with cognitive and affective aspects of decision-making. The investigators further predict that HD patients receiving CBT (vs. WL) will show decreased activity in those ROIs, and will no longer differ from HCs following CBT. A secondary aim of the proposed study is to determine the relationship between change in activity in brain regions of interest and hoarding-related symptoms and impairments. The investigators expect, that hemodynamic activity in the target ROIs will correlate with symptoms of HD and with performance on decision-making tasks; and that change in brain activity will correspond to both symptom and mechanism changes over the course of treatment. Finally, an exploratory aim is to explore, using both data-driven and model-constrained approaches, patterns of pre-treatment neural activity that predict response to CBT. The investigators predict that among treated HD patients, pre-treatment activity in the target ROIs will correlate significantly with HD symptom change from pre- to posttreatment. Results of the proposed study are expected to elucidate the neural mechanisms of successful response to CBT treatment for hoarding patients, and to set the stage for further treatment development and possible improvements in outcome for this disorder.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

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

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

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 20-65
  • Hoarding Disorder primary condition
  • Score at least 4 on the CGI
  • Free from all psychotropic medications for at least 4 weeks(5 weeks for fluoxetine)
  • Participant is fluent in English
  • Control over current living environment (i.e. not living in a nursing home or with relatives)
  • Physically able to complete therapy assignments (i.e able to discard etc)
  • Able to complete study measures
  • If female: Using an approved method of contraception

Exclusion Criteria:

  • More than 10 sessions of CBT for HD
  • Actively suicidality, previous suicide attempt, current use of self harming behaviors or is at risk for harming others
  • Current or past diagnosis of serious psychological disorder (psychotic disorder, bipolar disorder, substance use disorder or uncontrolled anorexia)
  • Psychiatric hospitalization within the past 12 months
  • History of anoxic or traumatic brain injury
  • Evidence of cognitive dysfunction that would interfere in the ability to provide informed consent or engage in CBT
  • Claustrophobia
  • Pacemaker, aneurysm clip, or other metal in the body that would pose a risk during fMRI?
  • If female: Pregnant or lactating

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Treatment
Cognitive-behavioral therapy
Behavioral: Cognitive Behavioral Therapy
Group cognitive-behavioral therapy for hoarding disorder, 16 weeks
No Intervention: Delayed Treatment
This group will receive the cognitive-behavioral therapy after a 16 week delay
No Intervention: Healthy Control
This group is matched to the immediate treatment group on age and gender. They do not receive an active treatment and will be used a a healthy comparator group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saving Inventory-Revised (SI-R)
Time Frame: Change from baseline at 8 weeks and 16 weeks after treatment
The SI-R is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter and compulsive acquisition
Change from baseline at 8 weeks and 16 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Global Impression (CGI) Severity (Self Report and Clinician Administered)
Time Frame: Change from baseline at 8 weeks and 16 weeks after treatment
The CGI is a widely used measure of global symptom severity (CGI-S) and symptom improvement after treatment (CGI-I). On the CGI-S the scale ranges from 1 (no symptoms) to 7 (extreme symptoms). On the CGI-I the scale ranges from 1 (very much improved) to 7 (very much worse). The CGI can be used in both a self-report and clinician administered version and this study utilizes both formats.
Change from baseline at 8 weeks and 16 weeks after treatment

Collaborators and Investigators

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

Sponsor

Hartford Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David F Tolin, Ph.D., Anxiety Disorders Center, Institute of Living

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)

July 1, 2013

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

October 6, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01MH101163-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will upload de-identified study data to an online database to be shared with colleagues upon request.

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.

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