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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arthritis, Psoriatic, Psoriasis

Intervention / Treatment
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* Behavioral: Immune Strength


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 14 Computer and internet access A valid email address Able to speak & read English Able to understand & sign informed consent Exclusion Criteria: PHQ9 score > 14 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>Assigned to Immune Strength program | Behavioral: Immune Strength<br>* Immune Strength is a 12 week online program that provides content, strategies, and guidance on how to improve your immune system and increase your mental wellbeing, with a focus on stress, sleep, nutrition, and exercise. In addition to the online program, each participant will be paired with a Cleveland Clinic Coach who will communicate with the participant via email. The Coach will help guide the participant throughout the program and provide encouragement and guidance for making behavior changes for making a more resilient immune system.<br>|
| Active Comparator: Control Group<br>Assigned to 12 week waitlist, receiving usual care. Study participants assigned to the wait list will receive access to Immune Strength 12 weeks after study commencement. | Behavioral: Immune Strength<br>* Immune Strength is a 12 week online program that provides content, strategies, and guidance on how to improve your immune system and increase your mental wellbeing, with a focus on stress, sleep, nutrition, and exercise. In addition to the online program, each participant will be paired with a Cleveland Clinic Coach who will communicate with the participant via email. The Coach will help guide the participant throughout the program and provide encouragement and guidance for making behavior changes for making a more resilient immune system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Patient Health Questionnaire-9 score (PHQ-9) at intervention completion. | The PHQ-9 is used as a screening tool for assessment of the severity of depressive symptoms. | PHQ-9 score will be collected at baseline after consent is signed and then immediately after the intervention is complete. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | PROMIS are a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults. | PROMIS measure scores will be collected at the start of the intervention and immediately after the intervention is complete. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, Psoriasis, Mental Health, Well being