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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01451697
Other study ID # DIMA003472HI
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date July 2011
Est. completion date October 2012

Study information

Verified date May 2019
Source Hartford Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Remediation
A computerized cognitive remediation program focused on attentional training will be used.
Control (Placebo)
The control condition will involve relaxation training.

Locations

Country Name City State
United States Anxiety Disorders Center, Institute of Living/Hartford Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

References & Publications (55)

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. Review. — View Citation

Auriel 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. — View Citation

Barbieri 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. — View Citation

Beck AT, Beck RW. Screening depressed patients in family practice. A rapid technic. Postgrad Med. 1972 Dec;52(6):81-5. — View Citation

BECK 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. — View Citation

Bell 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. — View Citation

Bernal G, Bonilla J, Padilla-Cotto L, Pérez-Prado EM. Factors associated to outcome in psychotherapy: an effectiveness study in Puerto Rico. J Clin Psychol. 1998 Apr;54(3):329-42. — View Citation

Castellanos FX, Sonuga-Barke EJ, Milham MP, Tannock R. Characterizing cognition in ADHD: beyond executive dysfunction. Trends Cogn Sci. 2006 Mar;10(3):117-23. Epub 2006 Feb 7. Review. — View Citation

Diefenbach 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. Epub 2007 May 10. — View Citation

Dwolatzky 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. — View Citation

Elstein 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. — View Citation

Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6. — View Citation

Epstein 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. — View Citation

Frost RO, Gross RC. The hoarding of possessions. Behav Res Ther. 1993 May;31(4):367-81. — View Citation

Frost RO, Hartl TL. A cognitive-behavioral model of compulsive hoarding. Behav Res Ther. 1996 Apr;34(4):341-50. Review. — View Citation

Frost RO, Kim HJ, Morris C, Bloss C, Murray-Close M, Steketee G. Hoarding, compulsive buying and reasons for saving. Behav Res Ther. 1998 Jul-Aug;36(7-8):657-64. — View Citation

Frost RO, Krause MS, Steketee G. Hoarding and obsessive-compulsive symptoms. Behav Modif. 1996 Jan;20(1):116-32. — View Citation

Frost RO, Steketee G, Grisham J. Measurement of compulsive hoarding: saving inventory-revised. Behav Res Ther. 2004 Oct;42(10):1163-82. — View Citation

Galbiati S, Recla M, Pastore V, Liscio M, Bardoni A, Castelli E, Strazzer S. Attention remediation following traumatic brain injury in childhood and adolescence. Neuropsychology. 2009 Jan;23(1):40-9. doi: 10.1037/a0013409. — View Citation

Grisham JR, Brown TA, Liverant GI, Campbell-Sills L. The distinctiveness of compulsive hoarding from obsessive-compulsive disorder. J Anxiety Disord. 2005;19(7):767-79. — View Citation

Grisham JR, Brown TA, Savage CR, Steketee G, Barlow DH. Neuropsychological impairment associated with compulsive hoarding. Behav Res Ther. 2007 Jul;45(7):1471-83. Epub 2007 Jan 12. — View Citation

Hartl TL, Duffany SR, Allen GJ, Steketee G, Frost RO. Relationships among compulsive hoarding, trauma, and attention-deficit/hyperactivity disorder. Behav Res Ther. 2005 Feb;43(2):269-76. — View Citation

Hartl TL, Frost RO, Allen GJ, Deckersbach T, Steketee G, Duffany SR, Savage CR. Actual and perceived memory deficits in individuals with compulsive hoarding. Depress Anxiety. 2004;20(2):59-69. — View Citation

Iervolino AC, Perroud N, Fullana MA, Guipponi M, Cherkas L, Collier DA, Mataix-Cols D. Prevalence and heritability of compulsive hoarding: a twin study. Am J Psychiatry. 2009 Oct;166(10):1156-61. doi: 10.1176/appi.ajp.2009.08121789. Epub 2009 Aug 17. — View Citation

Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. — View Citation

Kessler RC, Frank RG. The impact of psychiatric disorders on work loss days. Psychol Med. 1997 Jul;27(4):861-73. — View Citation

Kocsis JH, Zisook S, Davidson J, Shelton R, Yonkers K, Hellerstein DJ, Rosenbaum J, Halbreich U. Double-blind comparison of sertraline, imipramine, and placebo in the treatment of dysthymia: psychosocial outcomes. Am J Psychiatry. 1997 Mar;154(3):390-5. — View Citation

Kurtz MM, Ragland JD, Bilker W, Gur RC, Gur RE. Comparison of the continuous performance test with and without working memory demands in healthy controls and patients with schizophrenia. Schizophr Res. 2001 Mar 30;48(2-3):307-16. — View Citation

Kurtz MM, Seltzer JC, Shagan DS, Thime WR, Wexler BE. Computer-assisted cognitive remediation in schizophrenia: what is the active ingredient? Schizophr Res. 2007 Jan;89(1-3):251-60. Epub 2006 Oct 27. — View Citation

Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. — View Citation

Leon AC, Shear MK, Portera L, Klerman GL. Assessing impairment in patients with panic disorder: the Sheehan Disability Scale. Soc Psychiatry Psychiatr Epidemiol. 1992 Mar;27(2):78-82. — View Citation

Lindenmayer JP, McGurk SR, Mueser KT, Khan A, Wance D, Hoffman L, Wolfe R, Xie H. A randomized controlled trial of cognitive remediation among inpatients with persistent mental illness. Psychiatr Serv. 2008 Mar;59(3):241-7. doi: 10.1176/appi.ps.59.3.241. — View Citation

Medalia A, Aluma M, Tryon W, Merriam AE. Effectiveness of attention training in schizophrenia. Schizophr Bull. 1998;24(1):147-52. — View Citation

Medalia A, Dorn H, Watras-Gans S. Treating problem-solving deficits on an acute care psychiatric inpatient unit. Psychiatry Res. 2000 Dec 4;97(1):79-88. — View Citation

Medalia A, Revheim N, Casey M. The remediation of problem-solving skills in schizophrenia. Schizophr Bull. 2001;27(2):259-67. — View Citation

Mick E, Faraone SV, Spencer T, Zhang HF, Biederman J. Assessing the validity of the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form in adults with ADHD. J Atten Disord. 2008 Jan;11(4):504-9. Epub 2007 Oct 12. — View Citation

O'Connell RG, Bellgrove MA, Dockree PM, Lau A, Fitzgerald M, Robertson IH. Self-Alert Training: volitional modulation of autonomic arousal improves sustained attention. Neuropsychologia. 2008 Apr;46(5):1379-90. doi: 10.1016/j.neuropsychologia.2007.12.018. Epub 2007 Dec 27. — View Citation

O'Connell RG, Bellgrove MA, Dockree PM, Robertson IH. Cognitive remediation in ADHD: effects of periodic non-contingent alerts on sustained attention to response. Neuropsychol Rehabil. 2006 Dec;16(6):653-65. — View Citation

Rohling ML, Faust ME, Beverly B, Demakis G. Effectiveness of cognitive rehabilitation following acquired brain injury: a meta-analytic re-examination of Cicerone et al.'s (2000, 2005) systematic reviews. Neuropsychology. 2009 Jan;23(1):20-39. doi: 10.1037/a0013659. Review. — View Citation

Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. Erratum in: Biol Psychiatry. 2003 Sep 1;54(5):585. — View Citation

Samuels JF, Bienvenu OJ, Grados MA, Cullen B, Riddle MA, Liang KY, Eaton WW, Nestadt G. Prevalence and correlates of hoarding behavior in a community-based sample. Behav Res Ther. 2008 Jul;46(7):836-44. doi: 10.1016/j.brat.2008.04.004. Epub 2008 Apr 13. — View Citation

Sartory G, Zorn C, Groetzinger G, Windgassen K. Computerized cognitive remediation improves verbal learning and processing speed in schizophrenia. Schizophr Res. 2005 Jun 15;75(2-3):219-23. Epub 2004 Nov 13. — View Citation

Steketee G, Frost R. Compulsive hoarding: current status of the research. Clin Psychol Rev. 2003 Dec;23(7):905-27. Review. — View Citation

Stevenson CS, Whitmont S, Bornholt L, Livesey D, Stevenson RJ. A cognitive remediation programme for adults with Attention Deficit Hyperactivity Disorder. Aust N Z J Psychiatry. 2002 Oct;36(5):610-6. — View Citation

Tolin DF, Frost RO, Steketee G, Fitch KE. Family burden of compulsive hoarding: results of an internet survey. Behav Res Ther. 2008 Mar;46(3):334-44. doi: 10.1016/j.brat.2007.12.008. Epub 2008 Jan 3. — View Citation

Tolin DF, Frost RO, Steketee G, Gray KD, Fitch KE. The economic and social burden of compulsive hoarding. Psychiatry Res. 2008 Aug 15;160(2):200-11. doi: 10.1016/j.psychres.2007.08.008. Epub 2008 Jul 1. — View Citation

Tolin DF, Frost RO, Steketee G. An open trial of cognitive-behavioral therapy for compulsive hoarding. Behav Res Ther. 2007 Jul;45(7):1461-70. Epub 2007 Jan 16. — View Citation

Tolin DF, Kiehl KA, Worhunsky P, Book GA, Maltby N. An exploratory study of the neural mechanisms of decision making in compulsive hoarding. Psychol Med. 2009 Feb;39(2):325-36. doi: 10.1017/S0033291708003371. Epub 2008 May 19. — View Citation

Tolin DF, Robison JT, Gaztambide S, Blank K. Anxiety disorders in older Puerto Rican primary care patients. Am J Geriatr Psychiatry. 2005 Feb;13(2):150-6. — View Citation

Wagle AC, Berrios GE, Ho L. The cognitive failures questionnaire in psychiatry. Compr Psychiatry. 1999 Nov-Dec;40(6):478-84. — View Citation

Wexler BE, Anderson M, Fulbright RK, Gore JC. Preliminary evidence of improved verbal working memory performance and normalization of task-related frontal lobe activation in schizophrenia following cognitive exercises. Am J Psychiatry. 2000 Oct;157(10):1694-7. — View Citation

Wexler BE, Hawkins KA, Rounsaville B, Anderson M, Sernyak MJ, Green MF. Normal neurocognitive performance after extended practice in patients with schizophrenia. Schizophr Res. 1997 Aug 29;26(2-3):173-80. — View Citation

Woods SP, Lovejoy DW, Ball JD. Neuropsychological characteristics of adults with ADHD: a comprehensive review of initial studies. Clin Neuropsychol. 2002 Feb;16(1):12-34. Review. — View Citation

Wykes T, Reeder C, Corner J, Williams C, Everitt B. The effects of neurocognitive remediation on executive processing in patients with schizophrenia. Schizophr Bull. 1999;25(2):291-307. — View Citation

Wykes T, Reeder C, Williams C, Corner J, Rice C, Everitt B. Are the effects of cognitive remediation therapy (CRT) durable? Results from an exploratory trial in schizophrenia. Schizophr Res. 2003 Jun 1;61(2-3):163-74. — View Citation

* Note: There are 55 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Week 0 (Baseline) and Week 8 (Endpoint)
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