Cognitive Rehabilitation and Exposure Therapy for Veterans With Hoarding Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Saving Inventory Revised
研究概览
简要总结
This project will utilize a novel behavioral intervention for hoarding disorder that takes into account age and neurocognitive factors. The goal of this project is to gain knowledge on how treatment components may or may not work for Veterans with hoarding disorder. Further, the investigators hope to increase understanding of functional and long term outcomes in response to hoarding treatment.
详细描述
Objective
The investigators propose to conduct a randomized controlled trial comparing six months (26 sessions) of Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) treatment to a robust comparator, six months of Exposure Therapy alone, in 136 participants with HD.
Research Design: Assessments will be administered at baseline, during treatment (sessions 7, 13, 21), post-treatment, and 3- and 6-month follow-up, thus, all participants will be enrolled for one year.
Methodology: The primary objective is to evaluate whether CREST significantly reduces hoarding symptoms and improves functional capacity and quality of life when compared to exposure therapy alone. The investigators will also examine the impact of treatment mediators; treatment adherence, changes in executive functioning, avoidance, symptom severity on outcomes. Age and executive functioning will also be explored as potential moderators. Finally, by repeatedly measuring treatment targets, the investigators will examine time to maximum treatment effect in an effort to understand mechanisms of change.
Clinical Relationships: By providing a treatment for many Veterans with HD, the investigators can alter the course of their symptom trajectory and negative consequences, resulting in both healthcare costs savings and improved quality of life for Veterans.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Veterans age 18-85
- •Hoarding Disorder diagnosis outlined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)6 as measured by the Structured Interview for Hoarding Disorder (SIHD)67
- •HD as a primary diagnosis
- •Stable on medications for at least 12 weeks, with no pharmacologic changes expected or made during the 12-month study
- •Voluntary consent to participate
排除标准
- •Diagnosis of:
- •psychotic disorder
- •substance abuse disorder as measured by the Mini-International Neuropsychiatric Interview (M.I.N.I.)68
- •Current or history of any neurodegenerative disease
- •Active suicidal ideation
- •Concurrent participation in psychotherapy or ET for HD, or prior history of CREST for HD
结局指标
主要结局
Saving Inventory Revised
时间窗: Baseline to 6 month-follow-up (12 months total)
Hoarding symptom severity (primary outcome) will be measured using the Savings Inventory-Revised (SI-R)56, a 23-item self-report measure used to assess common hoarding symptoms. Subscales include clutter, acquisition, and difficulty discarding. The SI-R has demonstrated good internal consistency, divergent validity, concurrent validity, and test-retest reliability in clinical samples with hoarding. The total score will be used for analyses. Total of 23 items divided into 3 subscales, each item Likert scale ranges from 0-4 (0= not at all, 4= extreme), Clutter Subscale (9 items): scores greater than 13 indicate clinical significance (Max score=36), Difficulty Discarding/Saving Subscale (7 items): scores greater than 13 indicate clinical significance, Acquisition Subscale (7 items): scores greater than 15 indicate clinical significance (Max Score= 28). Total Max score = 92. A Total score greater than 40 is a typical score for people experiencing challenges with hoarding behaviors.
次要结局
- UCSD Performance-Based Skills Assessment (UPSA)(Baseline to 6 months post-treatment (on average 1 year))
- UCSD SORT Test(Baseline to 6 months post-treatment)
- Specific Levels of Functioning Test (SLOF)(Baseline to 6 months post-treatment)