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临床试验/NCT05571696
NCT05571696已完成不适用

Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases

Elaine Husni2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion.

研究概览

简要总结

Despite advances in effective psoriatic disease treatment, the disease still has a serious impact on mental health and well-being of millions of patients. Up to 20.7% of patients report poor mental health, compared to 7.1% of the general population. Mental health treatment involves a combination of medication and talk therapy to address such issues. However, there is increasing evidence that optimizing behaviors such as sleep, physical activity, stress, and nutrition are critical components in improving mental health too. Numerous online health programs have evolved to help patients optimize such behaviors but very little exists for patients with psoriatic diseases. The "Immune Strength" 12 week program utilizes online electronic coaching (eCoaching) with weekly access to a wellness professional to provide a low-cost, high-touch, personalized intervention that patients can access 24/7. In conjunction with traditional clinical care, the goal of this program is to leverage the convenience, affordability, scalability and effectiveness of an online eCoaching program to improve key physical behaviors, thereby reducing the mental health burden experienced by psoriatic disease patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

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

  • Patient of Cleveland Clinic
  • Adults (=18 years of age)
  • Diagnosis of psoriasis or psoriatic arthritis by a board certified physician.
  • PHQ9 score between 5 and 20
  • Computer and internet access
  • A valid email address
  • Able to speak & read English
  • Able to understand & sign informed consent

排除标准

  • PHQ9 score > 20
  • History of major depressive disorder
  • Currently receiving psychotherapy for major depressive disorder (MDD), anxiety or psychotic disorder
  • On a wait-list for psychotherapeutic treatment
  • Received treatment for a severe psychiatric illness in the previous 6 months
  • Demonstrate a notable suicidal risk at study visit

结局指标

主要结局

Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion.

时间窗: PHQ-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete.

The PHQ-9 is used as a screening tool for assessment of the severity of depressive symptoms.

次要结局

  • Patient-Reported Outcomes Measurement Information System (PROMIS)(PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete.)

研究者

发起方
Elaine Husni
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elaine Husni

Staff Rheumatologist

The Cleveland Clinic

研究点 (2)

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