Mind Matters: A High Touch, Low Cost Approach to Improving Mental Health Outcomes in Patients With Psoriatic Diseases
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
- 否
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
Elaine Husni
Staff Rheumatologist
The Cleveland Clinic
