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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 20 - Computer and internet access - A valid email address - Able to speak & read English - Able to understand & sign informed consent

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Intervention Group 		Assigned to Immune Strength program
  • Behavioral: Immune Strength
    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.
Active Comparator
Control Group 		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
    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.

Recruiting Locations

The Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Sandra Hodnick, MBA
216-444-6039
hodnics@ccf.org

More Details

NCT ID
NCT05571696
Status
Recruiting
Sponsor
Elaine Husni

Study Contact

Sandra Hodnick, MS
216-444-6039
hodnics@ccf.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center