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| Name | Class |
|---|---|
| National Psoriasis Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | Assigned to Immune Strength program |
|
| Control Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Strength | Behavioral | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Husni, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D011565 | Psoriasis |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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|
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |