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临床试验/NCT04069741
NCT04069741终止不适用

Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
2
主要终点
Numerical Pain Rating Scale

研究概览

简要总结

This study evaluates a Decision Aid to help patients with de Quervain's tenosynovitis decide how to treat their condition.

For patients with symptoms of depression, half the participants will receive a psychological intervention (Toolkit) to improve depression and pain from de Quervain's tenosynovitis.

The investigators hypothesize that both the Decision Aid and the Toolkit will be feasible, and that the Toolkit will improve pain and function compared to usual care.

详细描述

The investigators are doing this research to see if they can improve the management of patients with de Quervain's tendinopathy. In the first part of this study, a Decision Aid (DA) has been developed to help participants make choices about their treatment.

Decision aids are designed to provide patients with balanced, complete, and understandable information about their options for management of their condition, as well as risks and benefits, in order to help them determine their preferences according to their values. Research has shown that patients felt more knowledgeable and better informed with a more active role in decision making after using DAs.

Additionally, research has shown that depression affects pain and disability experienced by patients with de Quervain's tenosynovitis. In the second part of our study, the investigators want to see whether a web based skills intervention (Toolkit) is more effective than usual medical care in improving pain and disability in patients with de Quervain's tenosynovitis and symptoms of depression.

The Toolkit is delivered online and can be accessed at home. Similar skills interventions in patients with musculoskeletal injury have been shown to improve pain and function.

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
None

入排标准

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

入选标准

  • Adults (≥18 years) diagnosed with de Quervain's tenosynovitis
  • English fluency and literacy
  • Ability to give informed consent

排除标准

  • Inability or unwillingness to participate in decision aid (DA) and/or Toolkit-depression
  • Major medical comorbidity expected to worsen in the next 6 months
  • Comorbid chronic pain condition
  • Antidepressant medications changes in the past 6 months
  • Severe and untreated mental health conditions or active substance dependence
  • Secondary gains such as litigations or worker compensation procedures that may interfere with patients' motivation for treatment
  • No online device available to use the DA and Toolkit-depression

结局指标

主要结局

Numerical Pain Rating Scale

时间窗: 6 months

This scale measures the patient's pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain).

QuickDASH score (Disabilities of the Arm Shoulder and Hand)

时间窗: 6 months

This questionnaire measures individual's ability to complete daily tasks and the severity of their symptoms. The scoring scale ranges from 0 (no disability) to 100 (most severe disability).

次要结局

  • Patient Health Questionnaire 9(6 months)
  • Pain Catastrophizing Scale(6 months)

研究者

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

Neal Chung-Jen Chen

Interim Chief of the Hand & Arm Center

Massachusetts General Hospital

研究点 (2)

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