An Early Phase 1 interventional study of Cognitive Remediation and Control (Placebo) in Hoarding Disorder and Attentional Impairment, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-20.
Sponsored by Hartford Hospital · Early Phase 1, Interventional, and Treatment
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.
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).
32 studies on the registry are indexed under Hoarding Disorder; 5 are open to participants now.
This study's planned enrollment of 20 is below the median of 37 across 28 interventional studies indexed under Hoarding Disorder.
Browse Hoarding Disorder studies →Hartford Hospital is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 5 (36%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Cognitive Remediation
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.
Behavioral: Control (Placebo)
A computerized cognitive remediation program focused on attentional training will be used.
The control condition will involve relaxation training.
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).
Time frame: Week 0 (Baseline) and Week 8 (Endpoint)
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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