跳至主要内容
临床试验/NCT05254015
NCT05254015Enrolling By Invitation不适用

Cognitive Rehabilitation and Exposure Therapy for Geriatric Hoarding

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
150
试验地点
2
主要终点
Change in Saving Inventory-Revised (SI-R)

研究概览

简要总结

Hoarding disorder (HD) is a chronic, progressive, and debilitating psychiatric condition that leads to devastating personal and public consequences, particularly for older adults. This confirmatory efficacy trial will advance our knowledge of the mechanisms of action in the treatment of HD as well as reduce symptom severity, disability, and community consequences.

详细描述

Hoarding disorder (HD) is a chronic, progressive, and debilitating psychiatric condition that leads to devastating personal and community consequences, particularly for older adults. HD is defined by persistent difficulty discarding or parting with possessions due to distress associated with discarding, urges to save, and/or difficulty making decisions about what to keep and what to discard. As a result, clutter accumulates and fills active living areas, preventing the normal use of space and resulting in distress and disability. Community epidemiological reports estimate the prevalence of clinically significant hoarding symptoms at 7% in individuals over age 60 and even higher rates in those over age 70. HD is the only neuropsychiatric condition that progresses in severity and population prevalence with age apart from dementia.

Inhibition and cognitive switching have been identified as key deficits in older adults with HD. These executive functioning areas are consistent with the RDoC cognitive control domain and particularly the goal selection, updating, representation, and maintenance subconstruct. Findings suggest that these deficits may contribute to the symptomatic expression of HD, degree of functional impairment, and modest responses to HD treatment. Furthermore, anticipatory and experiential fear and anxiety, consistent with the RDoC constructs of acute and potential threat, lead to sustained problems with discarding items and clutter accumulation. When these constructs are targeted, our group has produced clinically and statistically significant outcomes.

Consistent with NIMH strategic goal 3.1, to arrive at effective treatment approaches for unmet therapeutic domains in behavioral science, this project seeks to conduct the first confirmatory efficacy trial for older adults with HD. We propose a RCT comparing CREST to a case management control condition for 150 adults age 50 and older with HD. We are examining age as a moderator and will therefore include both midlife and late life participants. An evaluation of treatment outcome, including hoarding severity and functional outcomes, will be conducted at baseline (0 months), mid-treatment (3 months), end of treatment (6 months), 3-month (9 months) and 6-month follow-up (12 months). Participants will receive 26 weekly 60-minute individual sessions over the course of 32 weeks maximum (6-7.5 months). They will receive 50% in home and 50% office visits. We will examine factors that mediate improvement in CREST (improved inhibition/cognitive switching and reduction in fear/anxiety of discarding items) through physiological, behavioral, self-report, and paradigm assessments. Individual factors (e.g., age and other demographic factors, baseline cognitive control, baseline hoarding severity) and treatment factors (e.g., session attendance) will be evaluated as moderators. The specific aims include determining confirmatory efficacy of CREST, mechanisms of CREST effects, and moderators of CREST. If successful, this project would lead to an effectiveness trial in a real world setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Blinded controlled trial

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults age 50 and older
  • voluntary informed consent for participation
  • DSM-5 diagnosis of HD
  • HD as a primary, most severe diagnosis
  • stable on medications for at least 8 weeks

排除标准

  • current psychosis or mania as measured by the Mini-International
  • current or history of any neurodegenerative disease
  • substance use disorder
  • current use of benzodiazepine medication
  • suicidality
  • current participation in exposure-based therapy

结局指标

主要结局

Change in Saving Inventory-Revised (SI-R)

时间窗: through study completion, an average of 1 year

Hoarding symptom severity will be measured using the Saving Inventory-Revised (SI-R), a 23-item self-report measure used to assess common HD symptoms. Subscales include excessive clutter, compulsive acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, concurrent validity, divergent validity, and test-retest reliability in clinical samples with HD. The total score will be used for analyses.

Change in Self-report Clutter Image Rating (CIR)

时间窗: through study completion, an average of 1 year

The Clutter Image Rating Scale (CIR) is a measure using a series of 9 photographs each of a kitchen, living room, and bedroom with varying levels of clutter. Participants and the rater independently select the photograph that most closely resembles each of the three rooms in the home. Internal consistency, test-retest reliability, inter-rater reliability, and correlations with validated HD measures for the CIR were high.

次要结局

  • PROMIS-43 Profile v2.(through study completion, an average of 1 year)
  • UCSD Performance-Based Skills Assessment (UPSA-2)(through study completion, an average of 1 year)
  • UCSD SORT Test (U-SORT)(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Ayers

Professor

University of California, San Diego

研究点 (2)

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