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

Elaine Husni

Status: Enrolling

Conditions: Psoriasis; Arthritis, Psoriatic

Treatments: Behavioral: Immune Strength

Study type: Interventional

Funder types: Other

Identifiers

NCT05571696

IRB#21-320

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

Assigned to Immune Strength program

Treatment:

Behavioral: Immune Strength

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Immune Strength