Obsessive Compulsive DisorderNCT01956344
Neural Mechanisms of CBT Response in Hoarding Disorder
A study testing Cognitive Behavioral Therapy in people with Obsessive Compulsive Disorder, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Claustrophobia
- Pacemaker, aneurysm clip, or other metal in the body that would pose a risk during fMRI?
- If female: Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety Disorders Center, Institute of Living
Hartford, Connecticut, 06106
About this study
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.
Read the 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.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Hoarding Disorder, Clutter, CBT, Cognitive behavior therapy, fMRI, Obsessive compulsive disorder (OCD), Healthy control
- Medical subject headings
- Obsessive-Compulsive Disorder, Hoarding Disorder, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Group cognitive-behavioral therapy for hoarding disorder, 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Cognitive-behavioral therapy Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline at 8 weeks and 16 weeks after treatment
Secondary outcomes (1)
Clinician Global Impression (CGI) Severity (Self Report and Clinician Administered)
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.
Measured: Change from baseline at 8 weeks and 16 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2018
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David Tolin, Hartford Hospital
- Investigators
- David F Tolin, Ph.D., Principal investigator, Anxiety Disorders Center, Institute of Living
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956344
- Sponsor's protocol ID
- 1R01MH101163-01
- Other IDs
- 1R01MH101163-01
- Status last verified
- Aug 2019
- First submitted
- 12 Sep 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will upload de-identified study data to an online database to be shared with colleagues upon request.
Publications
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.
PubMed 36877480Wootton 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.
PubMed 32362128Stevens 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.
PubMed 31676206Tolin 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.
PubMed 31008633Levy 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.
PubMed 30513489Tolin 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.
PubMed 29751168
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of CBT Response in Hoarding Disorder
- ClinicalTrials.gov ID
- NCT01956344
- Acronym / sponsor ID
- 1R01MH101163-01
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Hoarding Disorder, Clutter, CBT, Cognitive behavior therapy, fMRI, Obsessive compulsive disorder (OCD), Healthy control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive-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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyGroup cognitive-behavioral therapy for hoarding disorder, 16 weeks | Behavioural | Immediate Treatment |
Primary outcome
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
1 secondary outcome
Clinician Global Impression (CGI) Severity (Self Report and Clinician Administered)
Time frame: Change from baseline at 8 weeks and 16 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 36877480Tolin 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.
- Derived from this study: PubMed 32362128Wootton 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.
- Derived from this study: PubMed 31676206Stevens 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.
- Derived from this study: PubMed 31008633Tolin 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.
- Derived from this study: PubMed 30513489Levy 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.
- Derived from this study: PubMed 29751168Tolin 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.
- Individual participant dataSharing planned: Yes. We will upload de-identified study data to an online database to be shared with colleagues upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David F Tolin, Ph.D. principal investigator
Anxiety Disorders Center, Institute of Living
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Obsessive Compulsive Disorder, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saving Inventory-Revised (SI-R) (time frame: Change from baseline at 8 weeks and 16 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01956344, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.