Neural Mechanisms of CBT Response in Hoarding Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Hartford Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Tolin, Hartford Hospital
ClinicalTrials.gov Identifier:
NCT01956344
First received: September 12, 2013
Last updated: October 6, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Obsessive Compulsive Disorder
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neural Mechanisms of CBT Response in Hoarding Disorder

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • Saving Inventory-Revised (SI-R) [ Time Frame: Change from baseline at 8 weeks and 16 weeks after treatment ] [ Designated as safety issue: No ]
    The SI-R is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter and compulsive acquisition


Secondary Outcome Measures:
  • Clinician Global Impression (CGI) Severity (Self Report and Clinician Administered) [ Time Frame: Change from baseline at 8 weeks and 16 weeks after treatment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Treatment
This group will receive immediate CBT
Behavioral: Cognitive Behavioral Therapy
No Intervention: Delayed Treatment
This group will receive the CBT 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956344

Contacts
Contact: Bethany M Wootton, Ph.D 860-545-7752 bethany.wootton@hhchealth.org
Contact: Marla Genova, M.A. 860-545-7707 maral.genova@hhchealth.org

Locations
United States, Connecticut
Anxiety Disorders Center, Institute of Living Recruiting
Hartford, Connecticut, United States, 06106
Contact: Bethany M Wootton, Ph.D.    860-545-7752    bethany.wootton@hhchealth.org   
Principal Investigator: David F Tolin, Ph.D.         
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: David F Tolin, Ph.D. Anxiety Disorders Center, Institute of Living
  More Information

No publications provided

Responsible Party: David Tolin, Dr, Hartford Hospital
ClinicalTrials.gov Identifier: NCT01956344     History of Changes
Other Study ID Numbers: 1RO1MH101163-01, 1R01MH101163-01
Study First Received: September 12, 2013
Last Updated: October 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hartford Hospital:
Hoarding Disorder
Clutter
CBT
Cognitive behavior therapy
fMRI
Obsessive compulsive disorder (OCD)
Healthy control

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 22, 2014