Hoarding DisorderEarly Phase 1NCT01451697
Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding
A Early Phase 1 study testing Cognitive Remediation in people with Hoarding Disorder and Attentional Impairment, run by Hartford Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hoarding Disorder, Attentional Impairment
- What is being tested?
- Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2012
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety Disorders Center, Institute of Living/Hartford
Hartford, Connecticut, 06106
About this study
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.
Read the 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).
- Conditions
- Hoarding Disorder, Attentional Impairment
- Being tested
- Cognitive Remediation, Control (Placebo)
- Medical subject headings
- Hoarding Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationBehavioural
A computerized cognitive remediation program focused on attentional training will be used.
Control (Placebo)Behavioural
The control condition will involve relaxation training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cognitive Remediation | Experimental | 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. Receives: Behavioral: Cognitive Remediation |
| Control (Placebo) | Placebo comparator | 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. Receives: Behavioral: Control (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Performance Task (computerized version): change from Baseline in Attentional Functioning at 8 Weeks
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).
Measured: Week 0 (Baseline) and Week 8 (Endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (55)Papers the sponsor has linked to this study.
- Other trials for Hoarding 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer DiMauro, BA, Principal investigator, Hartford HospitalDavid F Tolin, PhD, Study director, Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451697
- Sponsor's protocol ID
- DIMA003472HI
- Status last verified
- May 2019
- First submitted
- 10 Oct 2011
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Abramowitz JS, Wheaton MG, Storch EA. The status of hoarding as a symptom of obsessive-compulsive disorder. Behav Res Ther. 2008 Sep;46(9):1026-33. doi: 10.1016/j.brat.2008.05.006. Epub 2008 Jun 27.
PubMed 18684434Auriel E, Hausdorff JM, Herman T, Simon ES, Giladi N. Effects of methylphenidate on cognitive function and gait in patients with Parkinson's disease: a pilot study. Clin Neuropharmacol. 2006 Jan-Feb;29(1):15-7. doi: 10.1097/00002826-200601000-00005.
PubMed 16518128Barbieri L, Boggian I, Falloon I, Lamonaca D; Centro Diurno 5 (CD5) collaborators. Problem-solving skills for cognitive rehabilitation among persons with chronic psychotic disorders in Italy. Psychiatr Serv. 2006 Feb;57(2):172-4. doi: 10.1176/appi.ps.57.2.172.
PubMed 16452691BECK LH, BRANSOME ED Jr, MIRSKY AF, ROSVOLD HE, SARASON I. A continuous performance test of brain damage. J Consult Psychol. 1956 Oct;20(5):343-50. doi: 10.1037/h0043220. No abstract available.
PubMed 13367264Beck AT, Beck RW. Screening depressed patients in family practice. A rapid technic. Postgrad Med. 1972 Dec;52(6):81-5. doi: 10.1080/00325481.1972.11713319. No abstract available.
PubMed 4635613Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
PubMed 11483142Bernal G, Bonilla J, Padilla-Cotto L, Perez-Prado EM. Factors associated to outcome in psychotherapy: an effectiveness study in Puerto Rico. J Clin Psychol. 1998 Apr;54(3):329-42. doi: 10.1002/(sici)1097-4679(199804)54:33.0.co;2-k.
PubMed 9545170Castellanos FX, Sonuga-Barke EJ, Milham MP, Tannock R. Characterizing cognition in ADHD: beyond executive dysfunction. Trends Cogn Sci. 2006 Mar;10(3):117-23. doi: 10.1016/j.tics.2006.01.011. Epub 2006 Feb 7.
PubMed 16460990Diefenbach GJ, Abramowitz JS, Norberg MM, Tolin DF. Changes in quality of life following cognitive-behavioral therapy for obsessive-compulsive disorder. Behav Res Ther. 2007 Dec;45(12):3060-8. doi: 10.1016/j.brat.2007.04.014. Epub 2007 May 10.
PubMed 17559803Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.
PubMed 14594456Elstein D, Guedalia J, Doniger GM, Simon ES, Antebi V, Arnon Y, Zimran A. Computerized cognitive testing in patients with type I Gaucher disease: effects of enzyme replacement and substrate reduction. Genet Med. 2005 Feb;7(2):124-30. doi: 10.1097/01.gim.0000153666.23707.ba.
PubMed 15714080Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
PubMed 8290681Epstein JN, Johnson DE, Varia IM, Conners CK. Neuropsychological assessment of response inhibition in adults with ADHD. J Clin Exp Neuropsychol. 2001 Jun;23(3):362-71. doi: 10.1076/jcen.23.3.362.1186.
PubMed 11404813Frost RO, Gross RC. The hoarding of possessions. Behav Res Ther. 1993 May;31(4):367-81. doi: 10.1016/0005-7967(93)90094-b.
PubMed 8512538Frost RO, Hartl TL. A cognitive-behavioral model of compulsive hoarding. Behav Res Ther. 1996 Apr;34(4):341-50. doi: 10.1016/0005-7967(95)00071-2.
PubMed 8871366
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation for Neuropsychological Impairment in Compulsive Hoarding
- ClinicalTrials.gov ID
- NCT01451697
- Acronym / sponsor ID
- DIMA003472HI
- Conditions
- Hoarding Disorder, Attentional Impairment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Oct 2011 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cognitive Remediation | Experimental | Behavioral: Cognitive RemediationThe 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. |
| Control (Placebo) | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 RemediationA computerized cognitive remediation program focused on attentional training will be used. | Behavioural | Experimental: Cognitive Remediation |
| Control (Placebo)The control condition will involve relaxation training. | Behavioural | Control (Placebo) |
Primary outcome
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).
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 20 May 2019.
- Background: PubMed 18684434Abramowitz JS, Wheaton MG, Storch EA. The status of hoarding as a symptom of obsessive-compulsive disorder. Behav Res Ther. 2008 Sep;46(9):1026-33. doi: 10.1016/j.brat.2008.05.006. Epub 2008 Jun 27.
- Background: PubMed 16518128Auriel E, Hausdorff JM, Herman T, Simon ES, Giladi N. Effects of methylphenidate on cognitive function and gait in patients with Parkinson's disease: a pilot study. Clin Neuropharmacol. 2006 Jan-Feb;29(1):15-7. doi: 10.1097/00002826-200601000-00005.
- Background: PubMed 16452691Barbieri L, Boggian I, Falloon I, Lamonaca D; Centro Diurno 5 (CD5) collaborators. Problem-solving skills for cognitive rehabilitation among persons with chronic psychotic disorders in Italy. Psychiatr Serv. 2006 Feb;57(2):172-4. doi: 10.1176/appi.ps.57.2.172.
- Background: PubMed 13367264BECK LH, BRANSOME ED Jr, MIRSKY AF, ROSVOLD HE, SARASON I. A continuous performance test of brain damage. J Consult Psychol. 1956 Oct;20(5):343-50. doi: 10.1037/h0043220. No abstract available.
- Background: PubMed 4635613Beck AT, Beck RW. Screening depressed patients in family practice. A rapid technic. Postgrad Med. 1972 Dec;52(6):81-5. doi: 10.1080/00325481.1972.11713319. No abstract available.
- Background: PubMed 11483142Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
- Background: PubMed 9545170Bernal G, Bonilla J, Padilla-Cotto L, Perez-Prado EM. Factors associated to outcome in psychotherapy: an effectiveness study in Puerto Rico. J Clin Psychol. 1998 Apr;54(3):329-42. doi: 10.1002/(sici)1097-4679(199804)54:33.0.co;2-k.
- Background: PubMed 16460990Castellanos FX, Sonuga-Barke EJ, Milham MP, Tannock R. Characterizing cognition in ADHD: beyond executive dysfunction. Trends Cogn Sci. 2006 Mar;10(3):117-23. doi: 10.1016/j.tics.2006.01.011. Epub 2006 Feb 7.
- Background: PubMed 17559803Diefenbach GJ, Abramowitz JS, Norberg MM, Tolin DF. Changes in quality of life following cognitive-behavioral therapy for obsessive-compulsive disorder. Behav Res Ther. 2007 Dec;45(12):3060-8. doi: 10.1016/j.brat.2007.04.014. Epub 2007 May 10.
- Background: PubMed 14594456Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A, Jaffe D, Chertkow H. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003 Nov 2;3:4. doi: 10.1186/1471-2318-3-4.
- Background: PubMed 15714080Elstein D, Guedalia J, Doniger GM, Simon ES, Antebi V, Arnon Y, Zimran A. Computerized cognitive testing in patients with type I Gaucher disease: effects of enzyme replacement and substrate reduction. Genet Med. 2005 Feb;7(2):124-30. doi: 10.1097/01.gim.0000153666.23707.ba.
- Background: PubMed 8290681Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
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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.
Jennifer DiMauro, BA principal investigator
Hartford Hospital
David F Tolin, PhD study director
Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cognitive Remediation in people with Hoarding Disorder and Attentional Impairment, 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 6 inclusion and 3 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 20 May 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Continuous Performance Task (computerized version): change from Baseline in Attentional Functioning at 8 Weeks (time frame: Week 0 (Baseline) and Week 8 (Endpoint)). 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 NCT01451697, which also lists 55 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 20 May 2019.