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临床试验/NCT04712474
NCT04712474进行中(未招募)不适用

In-home Decluttering Augmentation of Group Cognitive-behavior Therapy for Hoarding Disorder: The Joining Forces Randomized Controlled Trial

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
Saving Inventory-Revised (SI-R)

研究概览

简要总结

The primary aim of trial is to determine the clinical efficacy of in-home decluttering augmentation of group CBT for reducing hoarding severity in adults with HD. The trial takes place in Sweden.

详细描述

Cognitive behavioral therapy (CBT) is the current evidence-based treatment for HD but the majority of sufferers remain symptomatic after CBT with impairing levels of clutter in their homes. Home visits, with a focus on in-home decluttering, have in previous research been shown to be a promising intervention when combined with CBT. However, augmenting CBT with subsequent home visits has not yet been tested in a randomized controlled trial (RCT). In response to this, in this trial, we aim to investigate the efficacy of a coordinated intervention, consisting of CBT and in-home decluttering for HD, in an RCT. In this trial, 90 participants with HD will initially receive 12 sessions of CBT through a psychiatric outpatient service. After CBT, participants will be randomized to receive either 10 home visits in 10 weeks, or to a wait list condition. Our hypothesis is that augmenting CBT with home visits will lead to a reduction in hoarding symptoms and clutter and improved daily functioning compared to wait list. We will also investigate the cost-economical aspects of the intervention. Results from this trial have the potential to reveal whether in-home decluttering should be added to CBT in order to reduce symptoms of hoarding and improve function in indviduals with HD.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 years or older.
  • •Hoarding disorder as primary psychiatric condition.
  • •Willing and able to understand and complete consent and study procedures.
  • •Living in the Stockholm county (Sweden) and within a 1-hour commute by public transport from the social services office.

排除标准

  • •Concurrent CBT or having received CBT for HD during the last two years, for a minimum of 8 sessions including active strategies for reducing acquisition and practice of discarding with a qualified therapist or 8 previous in-home decluttering sessions with a qualified social worker.
  • •Unable or unwilling to allow study staff into home for home assessment.
  • •Animal hoarding or squalid (i.e. extremely unhygienic) home conditions that are deemed to put the personnel at risk during the in-home decluttering.
  • •A diagnosis of organic brain disorder, intellectual disability, psychosis, bipolar disorder without stable medication or with symptoms within the last 6 months, anorexia nervosa or alcohol/substance dependence or abuse.
  • •Major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks.
  • •Immediate risk to self or others, requiring urgent medical attention, such as high suicidality risk.
  • •Participant not able to read and communicate in Swedish.
  • •Currently at high risk for eviction (for instance having received a "rättelseanmaning" by the housing company or Swedish court).
  • •Potential participant lives in the same household as an already included participant.

研究组 & 干预措施

In-home decluttering

Experimental

Study participants receive weekly sessions of in-home decluttering for 10 weeks.

干预措施: In-home decluttering practice (Behavioral)

Delayed treatment

No Intervention

Study participants receive weekly session of in-home decluttering after a 10 week delay.

结局指标

主要结局

Saving Inventory-Revised (SI-R)

时间窗: Change from baseline (week 0) to post-treatment (week 10),

The SI-R is a 23-item questionnaire with 3 sub-scales: 1) difficulty discarding, 2) excessive clutter, and 3) excessive acquisition.

Clutter Image Rating Scale (CIR)

时间窗: Change from baseline (week 0) to post-treatment (week 10).

Three sets of photographs, each comprising 9 photos of a room with varying levels of clutter. A selection is made as to which photograph best resembles the room of the participant.

次要结局

未报告次要终点

研究者

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

Volen Ivanov

Principal Investigator

Karolinska Institutet

研究点 (1)

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