NCT01956344

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

4.9 years

First QC Date

September 12, 2013

Last Update Submit

August 5, 2019

Conditions

Obsessive Compulsive Disorder

Keywords

Hoarding DisorderClutterCBTCognitive behavior therapyfMRIObsessive compulsive disorder (OCD)Healthy control

Outcome Measures

Primary Outcomes (1)

  • Saving Inventory-Revised (SI-R)

    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 Outcomes (1)

  • Clinician Global Impression (CGI) Severity (Self Report and Clinician Administered)

    Change from baseline at 8 weeks and 16 weeks after treatment

Study Arms (3)

Immediate Treatment

EXPERIMENTAL

Cognitive-behavioral therapy

Behavioral: Cognitive Behavioral Therapy

Delayed Treatment

NO INTERVENTION

This group will receive the cognitive-behavioral therapy after a 16 week delay

Healthy Control

NO INTERVENTION

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.

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Group cognitive-behavioral therapy for hoarding disorder, 16 weeks

Immediate Treatment

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anxiety Disorders Center, Institute of Living

Hartford, Connecticut, 06106, United States

Location

Related Publications (6)

  • Tolin DF, Levy HC, Hallion LS, Wootton BM, Jaccard J, Diefenbach GJ, Stevens MC. Changes in neural activity following a randomized trial of cognitive behavioral therapy for hoarding disorder. J Consult Clin Psychol. 2023 Apr;91(4):242-250. doi: 10.1037/ccp0000804. Epub 2023 Mar 6.

    PMID: 36877480DERIVED

  • Wootton BM, Bragdon LB, Worden BL, Diefenbach GJ, Stevens MC, Tolin DF. Measuring Within-Session and Between-Session Compliance in Hoarding Disorder: A Preliminary Investigation of the Psychometric Properties of the CBT Compliance Measure (CCM) and Patient Exposure/Response Prevention Adherence Scale for Hoarding (PEAS-H). Assessment. 2021 Sep;28(6):1694-1707. doi: 10.1177/1073191120918024. Epub 2020 May 2.

    PMID: 32362128DERIVED

  • Stevens MC, Levy HC, Hallion LS, Wootton BM, Tolin DF. Functional Neuroimaging Test of an Emerging Neurobiological Model of Hoarding Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jan;5(1):68-75. doi: 10.1016/j.bpsc.2019.08.010. Epub 2019 Sep 5.

    PMID: 31676206DERIVED

  • Tolin DF, Wootton BM, Levy HC, Hallion LS, Worden BL, Diefenbach GJ, Jaccard J, Stevens MC. Efficacy and mediators of a group cognitive-behavioral therapy for hoarding disorder: A randomized trial. J Consult Clin Psychol. 2019 Jul;87(7):590-602. doi: 10.1037/ccp0000405. Epub 2019 Apr 22.

    PMID: 31008633DERIVED

  • Levy HC, Katz BW, Das A, Stevens MC, Tolin DF. An investigation of delay and probability discounting in hoarding disorder. J Psychiatr Res. 2019 Feb;109:89-95. doi: 10.1016/j.jpsychires.2018.11.019. Epub 2018 Nov 22.

    PMID: 30513489DERIVED

  • Tolin DF, Hallion LS, Wootton BM, Levy HC, Billingsley AL, Das A, Katz BW, Stevens MC. Subjective cognitive function in hoarding disorder. Psychiatry Res. 2018 Jul;265:215-220. doi: 10.1016/j.psychres.2018.05.003. Epub 2018 May 4.

    PMID: 29751168DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive DisorderHoarding DisorderSpeech Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • David F Tolin, Ph.D.

    Anxiety Disorders Center, Institute of Living

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 12, 2013

First Posted

October 8, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)